BOSTON
PUBLIC
tlBRftRY
ORGAN TRANSPLANTS
HEARINGS
BEFORE THE
SUBCOMMITTEE ON
INVESTIGATIONS AND OVERSIGHT
OF THE
COMMITTEE ON
SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
NINETY-EIGHTH CONGRESS
FIRST SESSION
APRIL 13, 14, 27, 1983
[No. 16]
Printed for the use of the
Committee on Science and Technology
»-
ORGAN TRANSPLANTS
HEARINGS
BEFORE THE
SUBCOMMITTEE ON
INVESTIGATIONS AND OVERSIGHT
OF THE
COMMITTEE ON
SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
NINETY-EIGHTH CONGRESS
FIRST SESSION
APRIL 13, 14, 27, 1983
[No. 16]
Printed for the use of the
Committee on Science and Technology
23-029 O
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1983
For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402
COMMITTEE ON SCIENCE AND TECHNOLOGY
DON FUQUA, Florida. Chairman
ROBERT A. ROE, New Jersey
GEORGE E. BROWN, Jr., California
JAMES H. SCHEUER, New York
RICHARD L. OTTINGER, New York
TOM HARKIN, Iowa
MARILYN LLOYD, Tennessee
DOUG WALGREN, Pennsylvania
DAN GLICKMAN, Kansas
ALBERT GORE, Jr., Tennessee
ROBERT A. YOUNG, Missouri
HAROLD L. VOLKMER, Missouri
BILL NELSON, Florida
STAN LUNDINE, New York
RALPH M. HALL, Texas
DAVE McCURDY, Oklahoma
MERVYN M. DYMALLY, California
PAUL SIMON, Illinois
NORMAN Y. MINETA, California
RICHARD J. DURBIN, Illinois
MICHAEL A. ANDREWS, Texas
BUDDY MacKAY, Florida
TIM VALENTINE, North Carolina
HARRY M. REID, Nevada
ROBERT G. TORRICELLI, New Jersey
FREDERICK C. BOUCHER, Virginia
J. H. Poore, Executive Director
Robert C. Ketcham, General Counsel
Regina A. Davis, Administrator
David S. Jeffery, Minority Staff Director
LARRY WINN, Jr., Kansas
MANUEL LUJAN, Jr., New Mexico
ROBERT S. WALKER, Pennsylvania
WILLIAM CARNEY, New York
F. JAMES SENSENBRENNER, Jr.,
Wisconsin
JUDD GREGG, New Hampshire
RAYMOND J. McGRATH, New York
JOE SKEEN, New Mexico
CLAUDINE SCHNEIDER, Rhode Island
BILL LOWERY, California
ROD CHANDLER, Washington
HERBERT H. BATEMAN, Virginia
SHERWOOD L. BOEHLERT, New York
ALFRED A. (AD McCANDLESS, California
TOM LEWIS, Florida
Subcommittee on Investigations and Oversight
ALBERT GORE, Jr.,
HARRY M. REID, Nevada
HAROLD L. VOLKMER, Missouri
ROBERT A. ROE, New Jersey
RICHARD J. DURBIN, Illinois
JAMES H. SCHEUER, New York
Tennessee, Chairman
JOE SKEEN, New Mexico
ALFRED A. (ALJ McCANDLESS, California
CLAUDINE SCHNEIDER, Rhode Island
Robert B. Nicholas, Chief Counsel/Staff Director
Steven A. Owens, Counsel
James E. Jensen, Investigator
Donald L. Rheem, III, Minority Technical Consultant
(II)
CONTENTS
WITNESSES
April 13, 1983:
H<Ten?easse1ed E' F°rd' * Representative in Congress from the State of Page
BiILie ^j1' With ST°n' **%$? Haili'Capt- Jo^'a BlSric£'^ift"di^ii:
tor, Adriane; James Williams, M.D., associate professor of surgery,
University of Tennessee College of Medicine, Memphis, Tenn.; and
Cxary Hall transplant coordinator, University of Tennessee College of
Medicine, Memphis, Tenn s fi
School of Medicine, Stanford, Calif.; Thomas E. Starzl, M.D., professor
of surgery, University of Pittsburgh School of Medicine, Pittsburgh,
Pa.; and G Melvil e Williams, M.D., professor of surgery Johns Hop-
kins Hospital, Baltimore, Md jr,wumu.XMjp
Donald W. Denny director of organ procurement,' 'transplantation' 'office;
W S Vn Pltts^rgh School of Medicine, Pittsburgh, Pa, William
W. Ptaff, M.D past president Southeast Organ Procurement Founda-
tion, University of Florida College of Medicine, department of surgery
alertfwar^ick Rf11 Raym0nd Coleman> founding president, donor
April 14, 1983: ' 126
HMas'sachuIs0eatteey' * Representative in the Congress from the State of
Michele Jones, kidney transplant recipient; David Ogden, M.D., profes-
sor of medicine, chief, renal section, University of Arizona Health
H,wT CAenter; andT Thel™ King Thiel, vice chairman and executive
director, American Liver Foundation. 919
fnXrathf^°/ganf ^r°n,' Executive Director, Presidents' Commission
R.W 1 py °f Ethical Problems in Medicine and Biomedical and
Behavioral Research; Dr James Childress, professor of religious studies
Un1vPrSevSSn0frv medlcal education, department of religious studies,
University of Virginia; and Dr. Robert M. Veatch, professor of medical
town Universit1"6363 scholar' Kennedy Institute of Ethics, George-
Da£d Rnf ki^' IP"' o^'^he7chie'Fmedic^ 281
ppn'tPr C^i ?Va^f' ,res^arc^ scientist, health and population study
ft. lerInSftltut6' S%at$e' Wash'; and John McCabe, legal coun-
Chic o 111 Conference of Commissioners on Uniform State Laws,
April 27, 1983:' 374
^S^^^J^^s^' Secretary for Health' Department 499
C. Everett Koop, M.D Surgeon General, U.S. Public H^ih&iriceZZZ 514
Carolyne K. Davis Administrator, Health Care Financing Administra-
turn; accompanied by Dr. Donald Young .... 591
£ • " ?e£ry'lU' MD;. Acting Assistant Secretary of Defense [health
aitairs], Department of Defense; accompanied by Alexander Rodriquez,
M.D medical director O-Champus; and Robert L. Gilliat, Esq., Assist-
Defense1161"3 °Unsel tmanP°wer and health affairs], Department of
Hon. Dale Bumpers, a U.S.' Senator i^m"the Stete of Aribixis^s"'.;;!!;;!;!;;;;;;;; 588
(Hi)
IV
April 27, 1983— Continued
Dr. H. David Banta, M.D., Assistant Director for Health and Life Sci- Page
ences, Office of Technology Assessment 591
Kenneth W. Sell, M.D., Ph. D., American Association of Tissue Banks 637
Peter Safar, M.D., university professor and director of resuscitation re-
search center, University of Pittsburgh 647
Dr. Richard A. Rettig, professor and chairman, department of social
sciences, Illinois Institute of Technology 696
Dr. Jeffrey M. Prottas, visiting professor, center for health policy analysis
and research, Florence Heller Graduate School, Brandeis University 709
Winifred B. Mack, president, North American Transplant Coordinators
Orcra, ization, SUNY at Stony Brook 752
Appenc^.-v. Additional material submitted for the record 769
ORGAN TRANSPLANTS
WEDNESDAY, APRIL 13, 1983
House of Representatives,
Committee on Science and Technology,
Subcommittee on Investigations and Oversight,
„,, , Washington, D.C.
9 J?epSUKCOmi£ttee mj*> Pursuant to call, at 10 a.m., in room
2325, Rayburn House Office Building, Hon. Albert Gore, Jr. (chair-
man of the subcommittee) presiding.
Mr. Gore. The subcommittee will come to order
I would like to welcome all of our witnesses and guests
pJ wiTi!71111* u,he subco™m.ittee be^ns 3 dayg of hearings to
evaluate the problems in obtaining organs for transplant surgery.
Each of us has been moved by the stories of families seeking life-
savings organs for their critically ill loved ones. And no sooner has
one family s plight been resolved, when it seems as if another, and
then another, comes forth to stand in their place
I am sure that many of you have wondered, as I have, why there
isn t some system to help meet these compelling needs in a more
rational way. Certainly there has to be a better way than relying
on bursts of media publicity during what is an emotionally difficult
time for the patient s family. It was for this very reason, especially
H^LiT PerKsonally contacted to assist in such a search" that I
directed the subcommittee staff to conduct the investigation which
has brought us here today.
nJl WiU n° d°ubt ?0me M a surPrise to many of us here that some
organ procurement systems are already in place. These systems
Th£ ?itiaUy dTevel0ped by local sur^cal tea™ to find transplant-
Pnn1n^heyS> In many.cases, these local agencies were poorly
Xnflv tZanSWfr fhB ™reasm8 demands for kidneys and, more
recently, demands for other organs brought about by the great
strides in transplant surgery. We will hear this morning from iome
?o tm t °^ait Pr°cu.rement. agencies who have struggled valiantly
to fill a constantly increasing demand for transplantable organs,
trli1??1 ^m°St ei?mtnt Panel of surgical pioneers who will de-
scribe the advances in this life-saving area of science.
^or!Llr0ny ° ^he problem facing us, as we look at the present
shortage of available transplantable organs, is that we have a
flwSSL 0fA°/gans ™ the face. of Plenty. Let me cite some figures to
n wS PneSe£> approximately 5,000 kidneys are being trans-
fc 1 T^aUy- ?1Ve t}\ousands P^ents who are suitabll candi-
s«vfL hLi dney *ransPJants are currently maintained on life-
saving dialysis waiting for a suitable kidney. The potential life
quality improvements for these patients from successful transplant
surgery and the cost savings potential are enormous.
A similar situaton exists for liver transplants. Dr. Starzl— from
whom we will hear shortly— and his group at the University of
Pittsburgh have performed 111 liver transplants in the 2-year
period ending in January. Let me correct that and make it 112 be-
cause Dr. Starzl has been up all night transplanting yet another
liver, and comes to this hearing room from the operating room.
During this same time span, another 54 patients died while waiting
for a donor liver.
Artificial hearts may, in time, provide hope for those thousands
who could benefit from a heart transplant— currently there are 100
heart transplants per year — but development of artificial livers,
kidneys, and organs of similar complexity are many, many years
away.
An estimated 20,000 Americans will die this year from head inju-
ries, brain tumors, and other circumstances that leave organs
usable for transplantation. Only a small percentage of those people
actually donate their organs, even though a Gallup poll taken some
years ago indicated that 70 percent of all Americans were willing
to have their organs donated for transplantation at the time of
death.
Relatively few people actually sign a donor card or some other
designated document for organ donation. In Maryland, for exam-
ple, where the donor card is placed on the back of the driver's li-
cense, a recent survey showed that only 1.5 percent participated.
Nationally, what is the net result of this disparity between pro-
fessed intention and actual action by potential donors? Figures
from a Center for Disease Control study— which we will also hear
about today — found that 2 percent of the patients who die in
American hospitals could be considered suitable donors, yet organs
are actually being obtained from less than one-fifth of those poten-
tial donors.
Testimony during the next 2 days — and then on the third day,
April 27— will describe the efforts of those who toil in this field. We
will be hearing from experts in organ procurement and donor so-
licitation efforts, as well as from some of the families who have had
direct experience with the system. We will also hear testimony
from expert witnesses who will discuss the bioethical and legal
issues involved. On the third and final day, we will hear from the
Department of Health and Human Services and from a variety of
witnesses who will suggest changes to improve the present systems.
I am extremely hopeful that these hearings will provide a focal
point for improvements in the process and procedures for obtaining
organs for transplantation so that families will no longer feel com-
pelled to mount a solitary nationwide campaign.
I want to call on my colleagues for opening statements, but let
me note first that we are going to have a change in the sequence of
the panels. Panel 2 is going to come first — Mrs. Billie Hall with her
son, Brandon, age 13 months; Dr. James Williams, associate profes-
sor of surgery at the University of Tennessee, Memphis; Mr. Gary
Hall, transplant coordinator at the University of Tennessee, Mem-
phis; and Capt. John H. Broderick, and Mrs. John Broderick, with
their daughter, Adriane, age 28 months from Minden, La.
The reason for the change is good news, happy news. The long-
awaited donor for Brandon Hall was located at 7 a.m. this morning.
Mrs. Hall and her son will be flying back to Tennessee, along with
Dr. Williams and Gary Hall, for surgery this afternoon. It is a very
happy announcement. We are delighted you can be here with us
for a short time before you have to go. We are going to change the
panels for that reason.
Let me call on the ranking minority member of this subcommit-
tee, Mr. Skeen.
Mr. Skeen. Thank you very much, Mr. Chairman.
The 3 days of hearings beginning today take the subcommittee
into one of the most impressive areas of recent scientific break-
throughs. Nowhere is the human drama surrounding science great-
er than it is for organ transplants. The fate of waiting organ recipi-
ents, hoping that somewhere in the United States someone with
matched organ characteristics has had the vision and the charity
to provide for the donation of their organs after death, is always a
poignant story.
I know, because my niece, who will be testifying tomorrow, has
recently undergone kidney transplant surgery after 3 years of bi-
weekly dialysis treatments. I know the pain and trauma of adjust-
ing to a lifestyle completely dependent on a machine. I am learning
now, 2 months after Michelle's surgery, how the recent break-
through in transplant technology can make a bright and hopeful
new life from one burdened with debilitating medical treatments or
death.
Let me congratulate and express my gratitude to those members
of the medical community with us during our hearings for bringing
us to the point we are today. It seems such a short time ago that I
lost my sister to glomerulonephritis. She died in 1962; she was 28
years old. There were no options then, despite the best attention of
the medical profession. There simply wasn't anything they could
do.
The situation is illustrative of the rate or pace of change current-
ly underway in the scientific community. We are seeing it more
and more on this committee as major breakthroughs occur almost
every day. In less than two generations, we have progressed from a
situation where someone such as my sister was left with no option
but death, to the situation today where my niece, Michelle, has the
option of life either by machine or by transplant surgery. Certainly
there is a lot to be grateful for, and much more to look forward to.
The key to what some observers are referring to as a Renais-
sance in transplant surgery is the drug cyclosporine. First used in
Great Britain in 1978, this drug fights the body's rejection of trans-
planted organs, thereby improving the 1-year survival rate. The
chances for successful transplants for such organs as heart, lung,
kidney, and liver have more than doubled in the last 5 years.
With the improvements in surgical techniques and new drugs,
over 5,000 people benefited from organ transplants in 1981. The
number is growing all the time, and more organ recipients are ex-
periencing successful transplants. The future of this field of re-
search is, in my opinion, without limit. A decade from now, we will
find a medical community capable of major feats of not only trans-
planting organs, but of reconstructing damaged ones as well. The
benefits to many Americans will be truly astounding.
Our subcommittee applauds all of our witnesses, doctors, and pa-
tients alike, and we welcome you to Washington. We also bid you
farewell if you need to get out of here for that transplant today,
and we appreciate your time that you have given us. It is my hope
that we might be able to listen to you in these 3 days and find
some way to help this process along. Most of the networking for
organ donors and recipients has been from the ground up, and the
support organizations you now have are very impressive. If you
think the Federal Government can help, I would like to hear about
it. Under the leadership of our chairman, Mr. Gore, I am confident
that the subcommittee will take the necessary and proper steps to
aid in this progress.
Thank you, Mr. Chairman.
Mr. Gore. Thank you very much.
Congressman Scheuer has an opening statement.
Mr. Scheuer. Thank you, Mr. Chairman. I will make it brief. I
know we are all eager to get to the witnesses.
We are at a wonderful point in time. I want to thank you for
your leadership in bringing us all together. These transplants that
were once unthinkable are now a practical therapeutic alternative
to such expensive and life debilitating procedures as renal dialysis.
Now the transplant technology is here to stay, thanks to the drug
cyclosporine that has apparently solved the rejection problems.
We in Congress must evaluate and analyze how the Federal Gov-
ernment can aid in organ procurement and how we can make sure
that every patient who needs an organ for a transplant has one.
We must also examine the adequacy of the medicare coverage for
transplants, both in terms of the procedures and the length of time
that the benefits are available.
In no way should the Federal reimbursement mechanism act as
a disincentive to transplants which are far more live-saving, far
more live-enhancing, and far cost effective than conventional ther-
apies.
Let me congratulate you again on scheduling this remarkable
hearing, Mr. Chairman.
Mr. Gore. Thank you very much.
Congresswoman Schneider.
Mrs. Schneider. I would like to thank you, Mr. Chairman, for or-
ganizing and pulling together what I think is a very timely and in-
teresting hearing. I think all we need to do is to look at the news-
papers or turn on the television set and see the remarkable ad-
vances that have occurred in the area of organ transplants.
The thought of vital organs, such as livers, hearts, and kidneys,
being transplanted routinely at our Nation's best medical centers is
a tribute to how far transplant technology has evolved since its
earliest days a decade and a half ago. The works of Doctors Shum-
way, Starzl, and Williams — to name some of the leaders — combined
with the R&D of the pharmaceutical industry in perfecting a pow-
erful, yet safe and practical drug, cyclosporine, demonstrates great
hope and promise of modern medicine.
Now that the medical technology is so very advanced, we have to
make certain that its support system in terms of organ procure-
ment keeps pace. One of the witnesses later today, I am proud to
say, is from my State of Rhode Island, and very actively involved in
helping connect the supply with demand. I think it would certainly
be a tragedy if, after realizing that we have the technological
breakthrough medically and pharmaceutically, that we don't take
full advantage by affording this remarkable therapy to all needy
patients.
I feel certain that, through the work of the subcommittee and
elsewhere in Congress, we can have a very meaningful impact on
the availability of transplant surgery, and I look forward to the tes-
timony of our distinguished witnesses at this morning's hearing.
Thank you very much.
Mr. Gore. Thank you very much.
Mrs. Hall, if you and Brandon could come to the witness table.
We are delighted to have you here. Captain Broderick, I would like
you and Adriane to join them at the center of the table there. Dr.
Williams, you are already at the witness table. Mr. Hall, if you
could join us as well.
By way of introduction, let me say that Mrs. Billie Hall lives in
Walnut, Miss., with her son, Brandon, age 13 months. Brandon has
been awaiting a liver transplant for quite a long time now. As I
mentioned before, there was happy news just this morning which
will take Mrs. Hall and Dr. Williams and Mr. Gary Hall back to
Tennessee.
Capt. John Broderick and his daughter, Adriane, age 28 months,
live in Minden, La. They are also patients at the UT Health Center
with Dr. Williams, who is joining us. We also have Gary Hall, who
is the transplant coordinator at the University of Tennessee.
To introduce our Tennessee witnesses, I am honored to recognize
our distinguished colleague, Congressman Harold Ford.
STATEMENT OF HON. HAROLD E. FORD, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mr. Ford. Thank you very much, Mr. Chairman and other mem-
bers of the subcommittee, for your kind words and for granting me
the opportunity to introduce two distinguished professionals from
the great State of Tennessee and from my district at the Medical
Center.
Before I continue my introduction of our Tennessee guests, let
me say that I, too, am cognizant of the fact that there are problems
related to the organ procurement for transplants. Not long ago, my
office in Memphis, Tenn., was contacted by our local media to help
in the search for a liver donor for a child hospitalized in my dis-
trict. I was shocked and dismayed to learn that a media campaign
of that magnitude had to be launched in order to procure a suit-
able donor.
I commend both Chairman Gore and the Committee on Science
and Technology for this hearing today and for this subcommittee
taking the time out of its busy schedule to arouse the awareness
from the congressional standpoint, as well as public awareness, of
the problems associated with organ procurement for transplants.
The University of Tennessee's Center for Health Sciences has
made a giant stride in the science of organ transplants. It is one of
the three major centers engaged in liver transplants, and the only
designated kidney transplant center in west Tennessee. Since May
19, 1982, when the center conducted its first liver transplant, seven
other transplants have been successful in that medical center.
It is my distinct pleasure to introduce Dr. James W. Williams,
who heads the surgical team at the University of Tennessee that
has performed five liver transplants since last May; and Mr. Gary
Hall, the university's transplant coordinator. Without the invalu-
able services and knowledge of these two professionals, much of the
progress that we have made in our hometown would not be there.
We are proud today to have the two before this subcommittee in
the Congress.
Once again, let me say that it is my sincere pleasure to introduce
them, and to know that we do have a donor as of 7 o'clock this
morning for the son of Mrs. Hall.
Thank you, Mr. Chairman and the members of this subcommit-
tee.
Mr. Gore. Thank you very much, Congressman.
We want to hear first from Mrs. Billie Hall. Mrs. Hall, I know
this is a dramatic day for you. It is our hope, as I know it is yours,
that the experience you have been through will be of some benefit
to others who will be undergoing the same challenge of finding a
donor for a child who needs an organ to live. We are delighted to
have you here on this special day. If you could share some thoughts
with us, we would appreciate it.
STATEMENTS OF BILLIE HALL, WITH SON, BRANDON HALL;
CAPT. JOHN H. BRODERICK, WITH DAUGHTER, ADRIANE;
JAMES WILLIAMS, M.D., ASSOCIATE PROFESSOR OF SURGERY,
UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE, MEM-
PHIS, TENN.; AND GARY HALL, TRANSPLANT COORDINATOR,
UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE, MEM-
PHIS, TENN.
Mrs. Billie Hall. Thank you very much for having us. I thank
you not only for Brandon, but for everybody else who is here with
children that have Brandon's problems.
I would like to tell you a few things that happened to Brandon
over the last 13 months. Brandon was 2 weeks old when we found
out that he has biliary atresia. He had surgery at that time, and
they were hoping that the surgery that they did would correct the
problem long enough, at least until he could get big enough for a
transplant.
He did fine for 3 or 4 months, and then he started having bleed-
ing problems around his stomach. Dr. Whittington, Brandon's
doctor, told me that to live, Brandon would have to have a trans-
plant. He told us that we would have to have so much money to get
Brandon in the hospital. Brandon has SSI, and I don't have any in-
surance. He told me that medicaid would not pay. So, we were
faced with another problem. We had to get at least $30,000 togeth-
er to get Brandon in the hospital.
We have a small religious radio station in Walnut, and they got
behind us, and we worked for 5 months and raised $81,000. We
were fortunate. God was with us. There are so many people who
won't be as fortunate as we have been. There needs to be some-
thing done about the medicaid helping these children. It is so terri-
ble to see a child die because they do not have the money to pay
for getting help for their child. We did raise the money.
In December, Brandon started losing weight. He was going down
every day. They were afraid they were going to have to put him on
the list for a donor then. But we started feeding him with NG-2
and he gained weight back up to 19 pounds. We thought we were
in good shape then, but he started retaining fluid. He just started
doing real bad.
I am sorry.
Mr. Gore. That is all right.
Mrs. Billie Hall. This is a good day.
Mr. Gore. It is an emotional day. We understand.
Mrs. Billie Hall. Brandon's birthday was in March. The week
after his birthday, Dr. Williams and Dr. Whittington put Brandon
on the search list for a liver. They thought at that time that he
had 1 month or maybe 2 months before he would need the donor.
So, they weren't pushing it. They just had him on the search list.
A couple of weeks ago, Brandon started retaining fluid again and
running a fever and just having several recurring things happen-
ing to him, like the fluid and everything. So, they put him on the
rush list. They put him on top priority for a donor.
Thank God, this morning we did get one. We are one of the very
few that are so fortunate to find a donor. There needs to be so
much more public awareness. Until people know the need for these
children, we are going to have these problems. We have had so
many people behind us, so we are very fortunate. You can look
around. There are so many people here with children just like
Brandon that needs the surgery just as bad as my son does.
If there is anything that can be done to help to make more
public awareness or get a better system set up, we do need it. They
need it. We have got ours. With God's help, we are going to make
it. But there are so many here who might now. So, please, if there
is anything that you can do to help these others, we would appreci-
ate it so much.
Thank you.
Mr. Gore. Thank you, Mrs. Hall.
When these hearings were announced, we found that a lot of
people came with children who we didn't expect to come. But there
are a number of mothers and fathers with children who came to
these hearings for precisely the reasons you just outlined.
Our next witness is the father of a young child, Adriane, age 28
months, who is awaiting a transplant. Captain Broderick, we all
wish that you and your family could share in the joy that Mrs.
Hall feels this morning. The sharp disparity between the two expe-
riences you all are having today points up again the need for a na-
tionwide rational system to help families in this distress out. So, we
would be delighted to hear from you, Captain Broderick.
Captain Broderick. Thank you.
I have a short statement.
Mr. Gore. Captain Broderick, let me say for the record that you
are a captain on active duty in the U.S. Army; is that correct?
Captain Broderick. Yes, sir.
8
Mr. Gore. You are stationed where?
Captain Broderick. Louisiana Army Ammunition Plant.
Mr. Gore. Thank you very much. Please proceed.
Captain Broderick. Our daughter, Adriane is now 28 months old
and has biliary atresia. She was born November 30, 1980, in
Athens, Greece. She also exhibited jaundice on birth. Unfortunate-
ly, because of the environment we were in, it was not discovered as
quickly as Brandon's. She was flown to a military hospital in Ger-
many where the possibility of biliary atresia was diagnosed. Her
military physicians at that time were not very optimistic regarding
her survival, and indicated she would probably die within several
months without major surgery.
She was then transferred to Walter Reed Army Medical Center
where additional tests confirmed the diagnosis of biliary atresia.
Since the Army medical system at that time could not perform the
corrective surgery, she was transferred to Children's Hospital Na-
tional Medical Center in Washington, D.C., in February 1981.
There it was decided a Kasai procedure would be necessary in
order to find bile ducts large enough to prevent her liver from dys-
functioning and allow bile flow. At that time, she only had a 50-
percent chance of success. The operation was performed by Dr.
Kathryn Anderson. After some complications, she responded to the
surgery and was released in March 1981.
I was then stationed in Alabama, and her condition again began
to deteriorate in April. As a result, she was admitted to Vanderbilt
University Medical Center in May. Dr. Wallace Neblett revised the
original Kasai procedure, but the advancing cirrhosis she developed
made the operation very difficult. Her prognosis upon release was
poor. It was felt her liver would fail, and she would die within a
year.
She suffered increased bleeding from a portoenterostomy in
June, and was again readmitted to Vanderbilt for additional sur-
gery in February 1982.
After she was released, she was followed by numerous military
and civilian physicians in an attempt to stabilize or delay the ad-
vancing deterioration of her liver.
In August 1982, after examination by Dr. John Andersen of the
University of Texas Health Science Center at Dallas, the possibility
of a liver transplant was discussed as the only way to save her life.
We then traveled to the University of Tennessee Center for the
Health Sciences in Memphis. At that time it was one of the few
centers doing transplants. Dr. James W. Williams confirmed her
prognosis, and suggested Adriane would be an ideal candidate for a
liver transplant. After a long period of hopelessness, watching her
slowly die from this disease, a transplant gave us our first hope for
her continued survival.
Little did we know that her continually deteriorating medical
condition and the difficulty in finding a suitable organ for trans-
plantation were not the only obstacles to overcome in saving her
life.
As an active-duty member of the Armed Forces, CHAMPUS [Ci-
vilian Health and Medical Program for the Uniformed Services] is
responsible for providing medical care for my family if the normal
military medical system cannot provide that care. After allowing
coverage for three major operations, we were surprised to learn
CHAMPUS would only pay for her to die in a hospital and not for
the liver transplant which would save her life. If at any point a
transplant was necessary, I was personally responsible for the bills.
Since $65,000 is the cost of admittance for the hospital doing the
transplant, my only available means of getting the necessary funds
to save my daughter's life would be public fundraising or medicaid.
Further investigation revealed three reasons why my daughter's
medical condition was disallowed by CHAMPUS.
The first is, since there are a limited number of centers who are
actively doing the procedure, liver transplantation cannot be readi-
ly replicated, nor be provided with a predicted level of success at a
significant number of facilities and, therefore, it does not meet the
generally accepted standards of usual professional medical practice
in the general medical community.
The question as to whether this procedure is routine is not for
me to answer, but I assume the testimony the physicians from the
various centers will give will adequately demonstrate that liver
transplantation is an accepted standard of usual professional medi-
cal practice for treatment of severe liver dysfunction.
The second consideration is that other federally funded health
programs, as well as other third-party payers also consider the pro-
cedure to be investigational.
Based upon my research and the research of others, this is based
upon an outdated National Institutes of Health survey conducted
in October 1980, which states the liver transplant success rate is
approximately 38 percent. This survey was prior to the use of cyclo-
sporine A, and only mentions cyclosporine A as being used in limit-
ed human trials, specifically Dr. Starzl's work. The success rate is
obviously higher. As far as other federally funded health programs,
I have received limited Massachusetts medicaid coverage because
of Senator Kennedy's personnel's efforts. And it is my understand-
ing numerous States like New York and Pennsylvania consider
liver transplants therapeutic.
From my own experience, the University of Tennessee has in-
formed me the only major insurance carrier who has not provided
coverage at that hospital is CHAMPUS.
The final consideration is the high cost of the procedure, typical-
ly $50,000 to $60,000, versus the expected long-range benefit to be
derived. I, personally, find this argument repugnant, since it de
facto has set a dollar value to my daughter's life. It would appear
CHAMPUS is all too willing to pay for her to die, at a greater cost
than for her to live. The expected long-range benefit is her life. If
economics is the consideration, then the transplant is cost effective,
a position reinforced by the Surgeon General of the United States.
There are three hurdles in my opinion that we have to overcome.
The first is finding the funds to get your child into the hospital; the
second — obviously Brandon has met that hurdle — is finding a liver;
the third — typified by Jamie Fiske — is surviving the actual sur-
gery.
Why is the reimbursement issue important to us? Without the
funds to gain admittance, I cannot even achieve the first hurdle.
In conclusion, Adriane is still suffering from the debilitating ef-
fects of her biliary atresia, and ultimately she will succumb to liver
10
failure, probably within 18 months. She does have hope for contin-
ued survival with a good quality of life if she receives a successful
liver transplant. This, of course, is dependent upon our ability to
afford the operation.
Your recommendations that liver transplantation is not investi-
gational, combined with improved methods of organ procurement,
and the legislation currently in Congress which allows widespread
acceptance of the procedure, can save numerous lives from liver
disease — possibly Adriane's.
That concludes my oral testimony, sir.
Mr. Gore. Captain Broderick, so I understand your testimony,
before we complete the panel, CHAMPUS is the health plan pro-
vided by the U.S. Government to active-duty members of the mili-
tary, and the U.S. Government, through CHAMPUS, has refused to
pay for your daughter's liver transplant, in part because it would
cost $50,000 to $60,000; is that correct?
Captain Broderick. Yes, sir.
Mr. Gore. We will certainly have some questions about that
when the panel has concluded.
[The prepared statement of Captain Broderick follows:]
11
Our daughter, Adriane is now 28 months old and has biliary atresia. She
was born November 30, 1980 in Athens, Greece. Her jaundice on birth did not
clear up after several weeks, and she was flown to a military hospital in
Germany where the possibility of biliary atresia was diagnosed. Her military
physicians were not optimistic regarding her survival^ and indicated she
would probably die within several months without major surgery.
Adriane was then transferred to Walter Reed Army Medical Center, where
additional tests confirmed the diagnosis of biliary atresia. Since the Army
medical system could not perform corrective srugery, she was transferred to
Children's Hospital., National Medical Center in Washington, DC, in February
1981.
There it was decided a KASAI procedure would be necessary in order to
find bile ducts large enough to permit bile flow from the liver.
With only a 50% chance of success, the operation was performed by Dr.
Kathryn Anderson. After some complications., she responded to the surgery and
was released in March 1981.
Then stationed in Alabama, her condition began to again deteriorate in
April. As a result, she was admitted to Vanderbelt University Medical Center
in May. Dr. Wallace Neblett revised the original KASAI procedure, but the
advancing cirrhosis she developed made the operation difficult. Her prognosis
upon release was poor - it was felt her liver would fail, and she would die
within a year.
She suffered increased bleeding from a portoenterostomy in June, and was
agaln readmitted to Vanderbelt for additional surgery.
12
After she was released., she was followed by numerous military and civilian
physicians in an attempt to stabilize or delay the advancing deterroration of
her liver.
In August^ 1982, after examination by Dr. John Andersen of the University
of Texas Health Science Center at Dallas, the possibility of a liver transplant
was discussed as the only way to save her life.
We then travelled to the University of Tennessee Center for the Health
Sciences in Memphis, one of the few centers doing transplants. Dr. James W.
Williams confirmed her prognosis, and suggested Adriane would be an ideal
candidate for a transplant. After a long period of hopelessness., watching
her slowly die., a transplant gave us our first hope for her continued survival.
Little did we know that her continually deteriorating medical condition and
the difficulty in finding a suitable organ for transplantation were not the
only obstacles to overcome in saving her life.
As an active-duty member of the armed forces., CHAMPUS is responsible for
providing medical care for my family if the normal military medical system
cannot provide certain care.
After allowing coverage for three major operations, we were surprised to
learn CHAMPUS would only pay for her to die in a hospital and not for the
liver transplant which would save her life. If at any point a transplant was
necessary, I was on my own for the bills.
Since $65,000 is the cost of admittance for the hospital doing the
transplant, my only available means of getting the necessary funds to save my
13
daughter's life would be public funding raising or Medicaid, Further
investigation revealed three reasons why my daughter's medical condition
was disallowed by CHAMPUS.
The first is since there are a limited number of centers who are actively
doing the procedure, liver transplantation cannot be readily replicated nor be
provided with a predicted level of success at a significant number of facilities,
it does not meet the generally accepted standards of usual professional medical
practice in the general medical community.
The question as to whether this procedure is routine is not for me to
answer., but I assume the testimony the physicians from the various centers have
given adequately demonstrate that liver transplantation is an accepted standard
of usual medical practice for treatment of severe liver dysfunctions.
The second consideration is that "other federally funded health programs,
as well as other third-party payors also consider the procedure to be inves-
tigational."
This is based upon an outdated NIH survey conducted in October of 1980
which states the liver transplant success rate is approximately 38%. This
survey was prior to the use of Cyclosporin A, and only mentions Cyclosporin A
as being used in limited human trials. The success rate is obviously higher.
As far as other federally funded health programs., I have received limited
Massachusetts Medicaid coverage because of Senator Kennedy's efforts, and it
is my understanding numerous states like New York and Pennsylvania consider
liver transplants therapeutic. From my own experience, the University of
Tennessee has informed me the only major insurance carrier who has not provided
14
coverage at that hospital is CHAMPUS.
The final consideration is "the high cost of the procedure^ typically
$50,000 - 60^000^ versus the expected long-range benefit to be derived."
I personally find this argument repugnant since it defacto has set a dollar-
value to my daughter's life. It would appear CHAMPUS is all too willing to
pay for her to die, at a greater cost, than for her to live. The expected
long-range benefit is her life. If economics is the consideration then the
transplant is "cost-effective," a position reinforced by the Surgeon General
of the US.
Why is the reimbursement issue important - without the funds to gain
admittance, improved procedures for liver procurement are unnecessary.
In conclusion, Adriane is still suffering from the debilitating effects
of her biliary atresia, and ultimately she will succumb to liver failure,
probably within 18 months.
She does have hope for continued survival with a good quality of life if
she receives a successful liver transplant. This of course is dependent on
our ability to afford the operation.
Your recommendations that liver transplantation is not investigational,
with improved methods of organ procurement., and the legislation currently in
Congress which allows wide-spread acceptance of the procedure, can save
numerous lives from liver disease - possibly Adrianes'.
That concludes my oral testimony.
15
BIOGRAPHICAL SKETCH
JOHN M. BRODERICK
CAPTAIN, UNITED STATES ARMY
John M. Broderick, III, was born in Ft Dix, NJ, on 30 May 1956. He
graduated from High School in Bellingham, Massachusetts. He earned a
Bachelor of Arts Degree from Providence College in 1978.
He began his active duty career in June 1978 as a Second Lieutenant in
the Ordnance Corps, and graduated from the Ordnance Officer's Basic
Course (phase II - nuclear) as Distinguished Graduate.
From February 1979 to April 1982, he served in the 558th USAAG, Greece.
In April 1982, he returned to Redstone Arsenal, Alabama, and was assigned
to the 515th Ordnance Co.
In 1983, he graduated as the Honor Graduate, Ordnance Officer Advanced
Course. He is presently assigned to the Louisiana Army Ammunition Plant,
Shreveport, Louisiana.
Personal Data
Born: 30 May 1956 - Ft Dix, NJ
SSN: 014-48-5891
Parents: John M. and Sara P. Broderick, Jr.
Wife: Janet M. Broderick
Children: Adriane Marie Broderick
Home Address
19 Colin P. Kelly Drive
Minden, Louisiana 71055
Phone: (318)459-5309
16
Mr. Gore. Our next witness is Dr. James Williams, associate pro-
fessor of surgery at the University of Tennessee College of Medi-
cine. Dr. Williams, we are honored to have you with us today.
Please proceed with your testimony.
Dr. James Williams. Mr. Chairman and members, thank you for
allowing us the opportunity to come to Washington and speak with
you on this issue we consider to be very important to the health of
a growing number of Americans.
I want to personally express my thanks to Mrs. Hall for her her-
culean efforts to come here, and her almost unbelievable compo-
sure on her day of days, regardless of the outcome.
The development of liver transplantation at the University of
Tennessee Center for the Health Sciences is outlined in my written
testimony.
In summary, we initiated our liver transplant program in May
1982, a project based on extensive laboratory and clinical prepara-
tion. Since that time, a little less than a year now, we have per-
formed a total of seven transplants, three of the patients have been
discharged home, and two other patients, recently done, are await-
ing discharge.
This very gratifying start illustrates the concept that liver trans-
plantation can be performed successfully by more than a few select
centers. Several other centers are now organizing liver transplant
programs. Given adequate preparation, these programs will prove
similary successful and dispell the myth that liver transplantation
is merely a clinical experiment.
As a new liver transplant program, we face two major problems.
The first problem, encountered by approximately half the patients
referred to us, is the lack of financial support for the procedure.
All Federal agencies, including CHAMPUS and medicare, and
many private insurance carriers refuse to cover the procedure be-
cause of its experimental status.
The second problem we have encountered is the frequent difficul-
ty in finding a liver donor, particularly for a small child. Since the
child with end-stage liver disease has a relatively short period of
time to live, and since the donated liver is viable for a only a short
time once it is removed from the cadaveric donor, and since the
number of pediatric donors itself is small, the urgency of the need
for a donor can literally reach life and death magnitude. The wit-
nesses here today, Brandon and Mrs. Hall, as well as Adriane
Broderick, illustrate these two problems as graphically as they
could possibly be illustrated.
Mrs. Hall, confronted with a fatal illness in her child, has been
able to raise the necessary money and assure her son's admission
to a transplant center. Several other patients we have seen, howev-
er, in this same situation, have not been so successful and have
since succumbed.
What can be done at a national level to assist in solving these
problems? I don't have any magic solutions, but I have a few sug-
gestions for your consideration. One, in the area of donor availabil-
ity, public awareness and public understanding of the problems in-
volved is important— is probably the most important thing we can
pursue at this stage. The general public, I don't believe, realizes
the seriousness of the problem, nor the precious quality of this re-
17
source, donated solid organs. Organ donation always comes at a
tragic time. It is not a time when the family can think rationally.
These decisions have to be made at a prior time. This is in the
realm of public education, public relations, ways of educating the
public.
A second route to take is in hospital involvement. There are a
number of hospitals in this country in which organ donation occurs
rarely, is rarely considered. In smaller hospitals, the knowledge for
the need is not disseminated. I think we have to need to have a
uniform policy in our hospitals about the approach to organ dona-
tion. If the intensive care unit nurses or someone designated within
those units were given the opportunity or the job or the responsi-
bility for doing this to everyone, presenting the opportunity for
organ donation for every family with a relative or member of their
family dying, I think we would see increased availability of organs.
This would ritualize the process, defuse some of the emotionalism,
and make it a regular part of the care of this type of person.
In the area of funding, I would encourage us to make some steps
toward assuring uniformity in our hospital insurance carriers. A
number of carriers have, in my opinion, hidden behind the term
"experimental." This term is too vague in a time of inovation,
when new things are happening all of the time. If we excluded pay-
ment on the basis of experimental or newness, we would never do
anything new, we would never make any advances. So that needs
to be defined.
For those who do not have insurance — which probably represents
a large segment of children, because children happen to be the de-
pendents of young working people, many time changing jobs and
changing insurance companies, and a new insurance company may
not pick up the tab for a pre-existing illness — we still have a
number of people who don't have coverage at all. We could consid-
er doing these transplants with funding through the clinical re-
search center system.
I don't know how much money that would take, but it would ac-
complish three things. One, it would take care of the patients who
need a liver transplant in this country. Second, it would improve
the research and developmental support that we all agree is
needed. Third, it would do this without creating any new laws,
without creating any new bureaucracy, and without committing
funds for an indefinite period of time. This would be research-relat-
ed money.
I appreciate the opportunity to come to Washington to testify,
and I will be happy to answer questions should they arise. Thank
you.
Mr. Gore. Thank you very much, Dr. Williams.
We will hold questions until Mr. Hall has had an opportunity to
testify.
[The prepared statement of Dr. James Williams follows:]
18
LIVER TRANSPLANT PROGRAM AT
THE UNIVERSITY OF TENNESSEE
CENTER FOR THE HEALTH SCIENCES
The liver transplant program at the University of Tennessee began in
May of 1982, becoming the third active program in this country and the first
program to become organized in the Cyclosporine era. This program has evolved
in a major university setting and draws extensively from the expertise of
physicians and technicians in a wide variety of medical and scientific
disciplines. This broad background of support is extremely valuable, since
the problems encountered with patients in end-stage liver disease can be
both numerous and complex. Having accounted for this broad support, I would
like to concentrate this testimony on the development of the surgical aspects
of this program, and the problems encountered by the family of a small child
needing a liver transplant.
A kidney transplant program at the University of Tennessee began in 1970
and has been responsible for the development of an active organ retrieval
effort, as well as the performance of approximately 350 renal transplants.
This effort, based on the treatment and follow-up of patients receiving kidney
transplants, has provided the liver program with considerable experience in
transplantation biology and the management of immunosuppressed patients.
The author's interest in transplantation began in 1978, when he spent
six weeks at the University 'of Colorado observing the program under the
direction of Thomas Starzl, M. D. Fortified by the belief that a similar program
could be initiated elsewhere, we began preparations for a liver program at the
University of South Florida in Tampa. When it became apparent that this could
not be accomplished in that institution, the University of Tennessee accepted
our offer to start a program in Memphis.
19
Liver Transplant Program April 13, 1983
Congressional Testimony Page Two
Preparation for this program included recruitment of two skillful
surgeons experienced in kidney transplantation and general surgery. Over a
two year period, these surgeons and I carefully dissected the liver in
several cadavers in order to become familiar with the frequent variations in
liver anatomy and the technical aspects of multi organ retrieval. During
and preceding this two year period, we conducted a series of canine liver
transplant experiments, investigating the use of Cyclosporine. In addition
to the experimental data generated, these experiments provided valuable
technical experience in liver preservation and in the actual performance
of the transplant operation, which has been heavily drawn upon in the
subsequent clinical series.
Based on this laboratory and clinical preparation we began our
program and performed the first liver transplant in May of 1982, using
Cyclosporine as the mainstay of immunosuppression. In the nine months
since that time we have transplanted seven patients, three of whom have
been discharged home and two are awaiting discharge. We currently have two
patients with end-stage liver disease awaiting a suitable donor.
The results of our program support the concept that hepatic transplanta-
tion is a procedure of genuine therapeutic benefit. The patients selected for
transplantation at our institution have had end-stage liver disease and were
expected to live only a few weeks or months . The experience from our
institution indicates that, with careful preparation, a new program can
provide liver transplantation therapy in a safe and efficacious manner.
Enough details of the surgery and care of the patients are known so that
duplication of these results should be expected at other similar institutions.
20
Liver Transplant Program April 13, 1983
Congressional Testimony Page Three
It is, therefore, our opinion that liver transplantation should no longer
be considered experimental. This designation, used by several Federal and
private health care providers, denies transplantation to approximately one-
half of the patients referred to us with end-stage liver disease.
The child appearing before your committee, Brandon Hall, is a one year
old boy with a disease called biliary atresia. This is a condition, present
from infancy, in which the bile ducts normally connecting the liver to the
intestine are absent. Since bile is denied entry into the intestine, the
child becomes jaundiced and the liver experiences progressive scarring and
progressive loss of function. Symptoms of this disease include itching,
increased susceptibility to infection, fluid retention, vitamin malabsorption,
bleeding problems, growth failure and others. This condition occurs approxi-
mately in one in every 8,000 to 12,000 births and proves fatal in the majority
of affected children before the age of 3 years. Therapy for this condition
includes both surgical attempt at bile drainage (helpful in a small number of
children) and the treatment of symptoms produced by the obstructed bile flow.
Since the liver is progressively destroyed by this condition, the only hope
for extended life is a successful liver transplant.
Liver transplantation is a complicated, lengthy and tedious procedure.
The current evidence suggests that it can be successful in up to 60% to 70%
of the patients.
Liver transplantation in children is complicated by two features. The
first feature is the relative scarcity of suitable donors for children. The
second feature is the disproportionately high incidence of clotting of the
artery supplying small livers in these children. This is a fatal complication
unless another liver can be quickly found.
21
Liver Transplant Program April 13, 1983
Congressional Testimony Page Four
Last year Brandon's mother, Mrs. Billie Hall, was told that her six
month old son could not survive without a liver transplant. In addition to
the uncertainties regarding the future of her child, she was also told that
financing was a major problem. Since she had no insurance and the medical
care she had been receiving was afforded by Medicaid, she was told that her
child could not have a transplant unless she could raise the money herself.
In an all out appeal, Mrs. Hall was able to raise approximately $75,000.00,
and thereby, provide her son with access to this therapy. When we saw the
child for the first time, he weighed approximately eleven pounds and appeared
to be in poor condition. Through the therapy initiated by Dr. Peter Whitington,
Pediatric Gastroenterologist at LeBonheur Children's Hospital at the University
of Tennessee Center for the Health Sciences, Brandon has been able to grow and
gain weight. However, in the past few weeks his growth has stopped and
complications related to a failing liver have appeared. He is becoming
increasingly jaundiced, lethargic, and has constant fever of 101° to 102°.
Brandon Hall is now on the urgent list awaiting a new liver. Providing
a liver can be found, we believe his chances for long-term, indefinite survival
are good. Without the transplant he will live only a few weeks.
The future of liver transplantation will depend upon two broad areas of
advance. The first area will be improvements in the control of rejection
and improvements in the technical aspects of performing the surgery. This
will require research support. The second area of advance will come from public
awareness of the precious resource organ donation represents. Kidney and
cornea transplantation has been performed for over two decades and has afforded
thousands of people a richer and fuller life than otherwise possible.
22
Liver Transplant Program April 13, 19R3
Congressional Testimony Page Five
In many cases successful kidney transplants have undoubtedly improved life
expectancy as well, but an alternate form of life sustaining therapy (dialysis)
is available to patients with kidney failure. On the other hand, there is
no meaningful therapy short of transplantation for patients with end-stage
liver failure. Since the patient with end-stage liver disease has a
relatively short period of time to live, and since the donated liver is
viable for only a short time, once it is removed from a cadaveric donor,
new urgency is being progressively placed upon organ procurement. Based
on vital statistics defining both the incidence of death from liver disease
and the number of potential organ donors, it appears that the supply of
needed livers can be readily met. Meeting this- need, however, will come
through public education and efforts such as this committee is promoting.
Thank you for the opportunity of appearing before your committee.
Yours truly,
James W. Williams, M. D.
Associate Professor of Surgery
JWW:lc
23
Mr. Gore. Mr. Gary Hall is the transplant coordinator with the
University of Tennessee College of Medicine in Memphis. Welcome,
Mr. Hall.
Mr. Gary Hall. Thank you, Congressman Gore, for the opportu-
nity to appear this morning.
Mr. Gore. Congratulations on your success this morning, Mr.
Hall.
Mr. Gary Hall. Thank you. That really is the success of the co-
operative efforts that go on at all times among transplant coordina-
tors in this country. It is not my success, it is our success.
I have been requested to relate the activities or our organ pro-
curement program in locating suitable organs for transplantation.
My specific remarks will outline my activities related to finding a
suitable liver for a small pediatric recipient, such as Brandon Hall,
and the general approach to organ procurement at the University
of Tennessee.
Rarely are organ donors "found" by organ procurement coordina-
tors; rather, organ donors are brought to the attention of coordina-
tors as a result of a referral by health professionals not normally
involved in organ procurement.
Locating a suitable liver for a small pediatric recipient — or really
any recipient — involves a two-pronged effort: first of all, a local
effort, an ongoing systems approach that will be described later;
and two, a nationwide effort. This nationwide effort involves listing
the patient, along with acceptable donor parameters, on a national
telephone system called the North American Transplant Coordina-
tors Organization 24-Alert phone system; 24-Alert is an acronym
for the phone number of this system, and is accessible from any
telephone in the world. Mr. Don Denny, director of organ procure-
ment at the University of Pittsburgh which administers this
system, will comment later during these hearings relative to the
mechanics of that system.
In particularly urgent cases, such as the one involving Brandon
Hall, various organ donor programs are directly contacted to make
them aware of our need and requested not to reject infants as
organ donors in contrast to the usual policy — infant kidneys are
rarely needed for transplants. In these situations, our program ac-
cepts full fiscal responsibility for the organ retrieval procedure
where there is considerable doubt as the transplantability of the
donor's kidneys. To date, we have been successful in procuring a
suitable organ for every eligible patient awaiting liver transplanta-
tion at our center.
Our local organ procurement program, similar to organ procure-
ment programs in other areas, has been marginally successful in
retrieving an adequate number of organs for transplant.
The various attachments to this testimony represent our efforts
to develop an understanding of the inhibitions physicians and
nurses in our community have toward participating in organ pro-
curements. For a very long time now, organ procurement has been
struggling to be universally recognized in our medical community
as a valid and legitimate endeavor. Often those in authority in the
hospitals in our area, upon which we rely for eligible organ donor
referrals, either acquiesce or are apathetic to our requests to be
24
permitted to educate and inform nurses and physicians working in
hopital areas where organ donors are most likely to be found.
In contradistinction to the lack of uniform affirmative support
for organ donation on the part of hospitals in our area, we have
the definite impression that a majority of physicians and critical
care unit nurses favor cadaveric organ donation. This impression is
confirmed by positive responses to the survey questions concerning
physicians' and nurses' attitudes toward personal organ donation-
attachments one and four.
Despite these favorable attitudes, it is clear that a majority of
donors are not identified and referred to the transplant program.
Furthermore, it is the perception of most critical care nurses that a
majority of eligible donors under their care are not identified nor
are their families advised of their right to exercise the organ donor
option — attachments two and four.
In attachment four can be found data suggesting that consider-
able uncertainty exists on the part of critical care nurses as to
their hospital's position on organ donation. This fact further sug-
gests possible contributing causes of the nurses' uncertainty about
the identification of eligible organ donors.
Due to the lack of a uniform systems approach, organ procure-
ment coordinators spend most of their time selling through in-serv-
ice seminars and unscheduled visits to critical care units to ac-
quaint critical care nurses with organ donation procedures. These
sessions generally include an emotional appeal to the nurses to ap-
proach families of eligible organ donors or, at the very least, to con-
tact the organ procurement coordinator and permit them to discuss
donation with the potential donor's family.
The foregoing is not intended as an indictment of hospitals, phy-
sicians or nurses, nor is it intended to characterize them as apa-
thetic toward the needs of patients awaiting transplantation. These
institutions and professionals have some real and legitimate con-
cerns about their participation in facilitating organ donation.
These concerns may be summarized as follows:
One, the majority of organ donations occur in acute care hospi-
tals not associated with organ transplant programs. Consequently,
the focus of attention of these hospitals and staff is on aspects of
patient care not related to transplantation. Organ donation does
not directly benefit their patient population.
Second, there exists a general belief on the part of the physicians
and nurses that organ donation does not enjoy widespread public
support. That this notion has merit was confirmed in a public opin-
ion survey conducted by the Gallup Organization earlier this year.
This survey performed, for the National Kidney Foundation, found
that only 40 percent of those polled— 44 percent of white partici-
pants, and only 20 percent of black participants— indicated they
were either very or somewhat likely to want their own kidneys do-
nated after their death. Our experience in Memphis, where the
proportion of blacks in the population approaches 50 percent, con-
firms the findings of the Gallup survey. Approximately 20 percent
of black families approached about organ donation ultimately con-
sent to it. This circumstance serves to discourage physicians and
nurses treating a black patient who dies, and is otherwise suitable
for organ donation, from approaching that patient's family.
25
Finally, a continued major concern is the issue of public accept-
ance of brain death as the death of the person. Most physicians and
a majority of legislators accept the idea that an individual who has
suffered irreversible cessation of total brain function, regardless of
the continuance of function of other organ systems, is legally dead.
The level of certainty among critical care nurses is somewhat less
than that of physicians. It is not surprising, therefore, that a sub-
stantial proportion of families have difficulty accepting the expla-
nation that one is dead when they feel a pulse and see them
breathing, albeit that these processes are mechanically maintained.
It requires a concerned, compassionate and committed physician
and/or nurse to spend sufficient time with the family to help them
understand that their relative is truly dead. Family acceptance of
brain death of the individual is absolutely essential before a discus-
sion of organ donation can ensue and be expected to result in con-
sent for organ donation.
In conclusion, two things will have to occur before an adequate
number of organs for transplant will be available, in my opinion.
One, the adoption of uniform policy and procedures by all acute
care hospitals specifically delineating organ donor criteria and ap-
propriate procedures to ensure that the families of all eligible
organ donors are afforded the opportunity to donate. It is impera-
tive that all physicians and nurses staffing the emergency rooms
and intensive care units in these institutions be thoroughly versed
in such policies and procedures.
Second, adequate funding must be provided for an ongoing, con-
sistent and professionally done public education program. This pro-
gram's goal should be to help the public understand that brain
death is death and, further, to persuade and motivate a majority of
Americans to become organ donors.
Thank you for the opportunity to appear here today.
Mr. Gore. Thank you, Mr. Hall.
[The prepared statement of Mr. Gary Hall follows:]
26
ORGAN PROCUREMENT PROGRAM AT
THE UNIVERSITY OF TENNESSEE
CONGRESSIONAL TESTIMONY
I have been requested to related the activities of our Organ Procurement
Program in locating suitable organs for transplantation. My specific remarks
will outline my activities related to finding a suitable liver for a small
pediatric recipient, such as Brandon Hall, and the general approach to Organ
Procurement at The University of Tennessee.
• Rarely are organ donors "found" by organ procurement coordinators; rather,
organ donors are brought to the attention of coordinators as a result of a
referral by health professionals not normally involved in organ procurement.
Locating a suitable liver for a small pediatric recipient involves a two
pronged effort: (1) a local effort - an on-going systems approach that will be
described later; and (2) a nationwide effort. This involves listing the
patient, along with acceptable donor parameters, on a national telephone system
called, "The North American Transplant Coordinators Organization 24-Alert" phone
system. 24-Alert, an acronym for the telephone number of this service, is
accessible from any telephone in North America. Mr. Don Denny, Director of
Organ Procurement at The University of Pittsburg, administers the system, and
will comment during these hearings relative to the mechanics of this system.
In particularly urgent cases, such as the one involving Brandon Hall.
Various organ donor programs are directly contacted to make them aware of our
need and requested not to reject infants as organ donors in contrast to the
usual policy (infant kidneys are rarely needed for transplants). In these
situations our program accepts full fiscal responsibility for the organ
retrieval procedure where there is considerable doubt as to the transplan-
tability of the donor's kidneys. To date, we have been successful rn procuring a
suitable organ for every eligible patient awaiting liver transplantation at our
center.
Our local organ procurement program, similar to organ procurement programs
1n other areas, has been marginally successful in retrieving an adequate number
of organs for transplant.
The various attachments to his testimony represent our efforts to develop
an understanding of the inhibitions physicians and nurses 1n our community have
toward participating 1n organ procurement. For a very long time now, organ pro-
curement has been struggling to be universlally recognized in our medical com-
munity as a valid and legitimate endeavor. Often those 1n authority 1n the
hospitals 1n our area, upon which we rely for eligible organ donors, either
acquiesce or are apathetic to our requests to be permitted to educate and
Inform nurses and physicians working 1n hospital areas where organ donors are
most likely to be found.
In contradistinction to the lack of uniform affirmative support for organ
donation on the part of hospitals within our area, we have the definite
Impression that a majority of physicians and critical care nurses favor cada-
veric organ donation. This Impression 1s confirmed by positive responses to
survey questions concerning physicians and nurses' attitudes toward personal
organ donation (Attachments One and Four)
27
Despite these favorable attitudes, it is clear that a majority of donors
are not identified and referred to the Transplant Program (Attachment Three).
Furthermore,, it is the perception of most critical care nurses that a majority of
eligible donors under their care are not identified nor are their families
advised of their right to exercise the organ donor option (attachments Two and
Four).
In Attachment Four can be found data suggesting that considerable uncer-
tanity exists on the part of critical care nurses as to their hospital's position
on organ donation. This fact further suggests possible contributing causes of
the' nurses' uncertainty about the identification of eligible organ donors
(Attachment Four).
Due to the lack of a uniform systems approach, organ procurement coor-
dinators spend most of their time selling, through, in-service seminars and
unscheduled visits to critical care units to acquaint critical care nurses with
organ donation procedures. These sessions, generally include an emotional
appeal to the nurses to approach families of eligible organ donors or, at the
very least, to contact the organ procurement coordinator and permit them
to discuss the donation with the potential donor's family.
The foregoing is not intended as an indictment of hospitals, physicians or
nurses, nor is it intended to characterize them as apathetic toward the needs of
patients awaiting transplantation. These institutions and professionals have
some real and legitimate concerns about their participation in facilitating
organ donation. These concerns, may be summarized as follows:
I. The majority of organ donations occur in acute care hospitals not
associated with organ transplant programs. Consequently, the
focus of attention of these hospitals and staff is on aspects of
patient care not related to transplantation. Organ donation does not
directly benefit their patient population.
II. There exists a general belief on the part of physicians and nurses
that organ donation does not enjoy widespread public support. That
this notion has merit was confirmed in a public opinion survey con-
ducted by the Gallup Organization earlier this year. This survey,
performed for The National Kidney Foundation, found that only 40% of
those polled (44% of white participants and 20% of black participants)
indicated they were either very or somewhat likely to want their own
kidneys donated after their death. Our experience in Memphis, where
the proportion of blacks in the population approaches 50%, confirms
the findings of the Gallup Survey - approximately 20% of black fami-
lies approached about organ donation ultimately consent. This cir-
cumstance serves to discourage physicians and nurses treating a black
patient who dies, and is suitable for organ donation, from approaching
the patient's family.
III. A continued major concern is the issue of public acceptance of brain
death as the death of the person. Most physicians and a majority of
legislators accept the idea that an Individual who has suffered
irreversible cessation of total brain function, regardless of the con-
tinuance of function of other organ systems is legally dead. The
28
level of certainty among critical care nurses is somewhat less that
that of physicians (Attachments One and Four). It is not surprising
therefore, that a substantial proportion of families have difficulty
accepting the explanation that one is dead when they feel a pulse and
see them breathing, albeit that these processes are mechanically
maintained. It requires a concerned, compassionate and committed phy-
sician and/or nurse to spend sufficient time with the family to help
them understand that their relative is truly dead. Family acceptance
of brain death as death of the individual is absolutely essential
before a discussion of organ donation can ensue and be expected to
result 1n consent for organ donation.
In conclusion, two things will have to occur before an adequate number of
organs for transplant will be available:
I. The adoption of uniform Policies and Procedures by all acute care
hospitals specifically delineating organ donor criteria and
appropriate procedures to ensure that the families of all eligible
organ donors are afforded the opportunity to donate. It is imperative
that all physicians and nurses staffing the emergency rooms and inten-
sive care units in these institutions be thoroughly versed in such
Policies and Procedures.
II. Adequate funding must be provided for an on-going, consistent, pro-
fessional done Public Education Program. This program's goals should
be to help the public understand that brain death is death and,
further, to persuade and motivate a majority of Americans to become
organ donors.
Thank you for the opportunity of providing this testimony to your
committee.
Gary Hall
Transplant Coordinator
29
ATTACHMENT NUMBER ONE
PHYSICIAN SURVEY
During the late autumn and early winter of 1979, the attached questionnaire
pertaining to physician attitudes towards organ donation was mailed to approxi-
mately 1,500 physicians in Memphis and Shelby County, Tennessee. The mailing
list comprised those physicians who were active members of the Shelby County
Medical Society and resided in Shelby County. This questionnaire was patterned
after one utilized by the Nashville Transplant Program in 1972 (see attached
reprint.) A total of 574 physicians responded to the questionnaire, approxima-
tely 38%.
DEMOGRAPHICS OF RESPONDENTS
Age
Age
Number
Percent
29 or less
135
23.5
30-34
115
20.0
35-39
68
11.8
40-44
60
10.5
45-49
40
7.0
50-54
47
8.2
54-59
48
8.4
60-64
30
5.2
65 or over
29
5.1
Sex
Sex Number
Male 507
Female 51
Not Answered 16
Race
Race
Number
Percent
88.3
8.9
2.8
Percent
Caucasian 481
83.8
Negro 9
1.6
Oriental 11
1.9
Not Answered 73
12.7
Religion
Religion Number Percent
Protestant
387
67.4
Catholic
71
12.4
Jewish
59
10.3
Other
Christian
13
2.3
Other
Asian Sects
11
1.9
None
22
3.8
Not answered
11
1.9
Speciality
Speciality Number Percent
Surgical
126
22.0
Non-Surgical
432
75.3
Not answered
16
2.8
Present
Position
Position
Number
Percent
House Staff
159
22.7
Faculty
101
17.6
Private
Practice
262
45.6
Other
50
8.7
Not answered
2
0.3
30
The following tables indicate the responses tabulated to each of the six
questions:
8. CADAVERIC RENAL TRANSPLANTATION IS:
A. Effective 168(29.3%)
B. Effective in selected cases 372 (64.8%)
' C. Still experimental 16 ( 2.8%)
D. Dangerous or useless 3 ( 0.5%)
Not answered 15 ( 2.6%)
There were no differences in responses by Demographics except for medical
specialties in which 45.1% of those identifying themselves as surgeons marked the
"A." response as opposed to only 24.8% of the non-surgeons and 31.2% of those
not indicating their speciality.
9. ATTITUDE TOWARD KIDNEY DONATION AFTER MY DEATH:
A. Organ donor card signed 246 (42.9%)
B. Willing, but card unsigned 211 (36.5%)
C. Would not sign, but donation acceptable
if family consents 80 (14.1%)
D. Opposed to kidney donation after my
death 27 ( 4.8%)
Not answered 10 ( 1.8%)
Considering the "A." and "B." answers as positive responses and the "C."
and "D." as negative responses, there were no differences in positive vs. nega-
tive responses by age, sex, race, religion, speciality or position. However,
when isolating the "A." Responses according to the above demographics several
significant differences emerge. In the 40-44 age group, 58.3% claimed to have
signed their organ donor card. There were no significant differences by sex.
Although the numbers for non-caucasians were small, only 15% of this group vs.
42.9% of the Caucasians vs. 50.7% of those not indicating their race claimed to
have signed a donor card. The only other significant difference found related
to the religion of the respondent: 52.9% of Catholics vs. 30.5% of the Jewish
physicians marked response 'A."
31
10. ATTITUDE TOWARD FAMILY KIDNEY DONATION AFTER THEIR DEATH:
A. All of age have signed the organ
donor card 109 (19.0%)
B. Not signed, but I would encourage them
to do so 251 (43.9%)
C. I am neutral on the mater of their
signing a card 192 (33.2%)
D. Opposed to kidney donation after their
death 11 ( 1.9%)
Not answered 11 ( 1.9%)
Regarding "A." and "B." as positive responses and "C." and "D." as negative
responses, there were found to be no significant differences by age, sex or
medical speciality of the respondent. Again, the responses among non-Caucasians
were few (20), but only 35% of non-Caucasians vs 64.9% of Caucasians responded
positively to question 10. Among religious denominations, 50.9% of Jewish phy-
sicians and 54.5% of "Other" groups and "None" combined vs 68.6% of Catholic
physicians and 65.6% of Protestant physicians responded positively. Seventy-one
and four tenths percent of house staff vs. 57.0% of faculty and 59.7% of private
practice physicians responded positively.
11. ATTITUDE TOWARD PATIENTS UNDER MY CARE:
A. Would encourage them to sign organ
donor card 286 (49.7%)
B. If moribund, would encourage family
to consent to donation 165 (28.7%)
C. If moribund, would advise family of
right to donate, but not encourage 82 (14.5%)
D. Would not discuss matter with
family at all 25 ( 4.2%)
Not answered 16 ( 2.8%)
32
There were no significant differences identified when analyzing the data by
the various demographic stratifications.
12. CONCERNING THE DIAGNOSIS OF BRAIN DEATH:
A. Am familiar with and accept criteria
of brain death 448 (78,1%)
B. Mot familiar with criteria, but would
accept specialist's diagnosis 10/ U8.t>%)
C. Death not related to brain function,
but rather to cessation of circulation ,,,,_»
and respiration 7 ( 1'"'
0. No opinion _ 8 ( lA%)
Not answered 4 ( °*n)
No differences in responses were identified among the various demographic
stratifications.
13. CONCERNING THE MEDICO-LEGAL ASPECTS OF ORGAN DONATION:
A. State laws provide Medico-Legal
protection for organ donation ±5» U'.»*i
B. Not familiar with laws, but feel
potential legal liability is minimal 321 (55./%)
C. Medico-Legal liabilities are major
obstacle to organ donation ^3 i s.otj
D. No opinion 59 (10.2%)
Not answered 3 ( °'5%)
Although there were no significant differences in the responses by
groups combined.
The above survey results should be interpreted with caution since the level
of reI5on.es does not represent a majority of physicians within the area sur-
vived However, the proportionate level of participation is within expected
eve?; compared to othVsurveys with similar format and method of distribution.
33
UNIVERSITY OF TENNESSEE
COLLEGE OF MEDICINE
JAMES W PATE M D
Professor ft Chairman
LOUIS G BRITT. M D
Professor a Deputy
DEPARTMENT OF SURGERY
95 I Court Avenue
Memphis, Tennessee 38163
* Uimflm ft
\tl.^
Dear Doctor:
Your help in taking a few minutes to complete the enclosed questionnaire would be deeply
appreciated. For your convenience, this form has been layed out to permit ease in return. Of course,
return postage has been prepaid.
This study is being conducted under the auspices of the University of Tennessee Renal
Transplant Program for the purpose of developing a better understanding of the prevailing views and
opinions of physicians in the Mid-South toward renal transplantation and organ donation.
Please rest assured that individual responses will in no way be identified as to their source,
thus insuring strict anonymity
Thank you in advance for your time and cooperation.
Sincerely yours,
Louis G. Britt, M.D.
Director, Renal Transplantation
RENAL TRANSPLANT QUESTIONNAIRE
General Information 10
(Circle Appropriate Response in Questions 1 through 5)
ATTITUDE TOWARD FAMILY KIDNEY DONATION
AFTER THEIR DEATH (check one)
1 YOUR AGE: < 30. 30-34; 35-39; 40-44; 45-49, 50-54;
55-59; 60-64; 65+
SEX:
Race: Caucasian
Negro Oriental
4. RELIGION: Catholic Jewish
Other (please specify)
Prostestant
5 YEARS IN PRACTICE: < 2; 2-5; 6-10; 11-15; 16-20;
21-25; 25+
MEDICAL OR SURGICAL SPECIALTY
PRESENT POSITION (Check One)
a. Private Practice
b. House Staff
c Full Time Medical School Faculty
d. Other (please specify)
Organ Donation Information
8 CADAVERIC RENAL TRANSPLANTATION IS: (check one)
a. Effective
b Effective in selected cases .
c. Still experimental
d. Dangerous or useless
9. ATTITUDE TOWARD KIDNEY DONATION AFTER MY DEATH:
(check one)
a. Organ donor card signed
\ b. Willing, but card unsigned
c. Would not sign, but donation acceptable if
family consents
d. Opposed to kidney donation after my death.
[
12.
13.
a All of age have signed the organ
donor card
b. Not signed, but I would encourage them
to do so
c. I am neutral on the matter of their
signing a card
d. Opposed to kidney donation after their death
ATTITUDE TOWARD PATIENTS UNDER MY CARE: (check one)
a. Would encourage them to sign Organ
donor card
b. If moribund, would encourage family to consent
to donation
c If moribund, would advise family of right to donate,
but not encourage
d. Would not discuss matter with family at all
CONCERNING THE DIAGNOSIS OF BRAIN DEATH (check one)
a. Am familiar with and accept criteria of
brain death
b Not familiar with criteria, but would accept
specialists diagnosis
c. Death not related to brain function, but rather to
cessation of circulation and respiration
d. No opinion
CONCERNING THE MEDICO-LEGAL ASPECTS OF ORGAN DONATION
(check one)
a. State laws provide medico-legal protection
for organ donation
b. Not familiar with laws, but feel potential legal
liability is minimal
c. Medico-legal liabilities are major obstacle to
organ donation
d. No opinion
34
Physicians' Attitudes Towai
Donation
HARRY S. AURAM. MO. ROGER VANDF.R /.\VAA(.
H. KEITH JOHNSON. MD.t Nashville, Term
This material may be protected
bv Copyright Law (Title 17 U.S CM"
d Organ
l'lil). ;md
Tur. %\ rrLV of cadaveric homografls for renal
transplantation depends not only upon public
attitude toward oigan donation but upon tlie
physician who provides care for the dying.
Although the former has received some atten-
lion,1"3 the physician's viewpoint has not. This
study represents an initial attempt to explore
iliis area.
Method
In Ociober 1972 we circulated by mail a
questionnaire to 1,100 physicians in Nashville.
Tfim. and surrounding Davidson County
(Table 1). In a covering letter we assured strict
anonymity and enclosed an addressed, stamped
envelope. Aside from general information (age.
sex. race, religion, present medical position,
medical or surgical specialty, years in practice),
we diiccted four questions (with five graded
multiple choice answers for each) toward the
physician's attitudes involving the effectiveness
of cadaveric renal allogiafis, the donation of
his own kidneys in the event of his death, his
family's donation of their kidneys after death,
and the manner in which he discussed organ
donation with dying patients or their families.
Finally we asked for other comments.
Respondents
A total ol 542 physicians responded to the
questionnaire or 49.37, of the 1,100 question
naires. A recent study' of factors which influ-
ence physi<ians' response to mailed question-
naires indicated response rates varying from
34.23% to 57.07% according to the format
(including both design and reproduction pro-
cess) and postage (primarily first class com-
iriom the Department ol ritchialry (Dr. Abram). the De-
itariiticiil ol ll.oitatmica (Dr. Zwaag), and the Department ol
Undone. Vanrlcrbilt Univcnity School ol Medicine. Naih-
,ille. Teem J72J2.
Reprint irqunn 10 Dr. Abraro II the above adore*!.
l-ie'rnied at The American Society lor Artificial Internal
Oi|ani. Clncajo. April 4. 1974.
pared with bulk or third class). Within that
siiuly the format and postage most similai 10
those used in this report had a response rate of
5-1.47% among a sample si*c of 3RD. Hence, a
response rale of 4!l.3% should be considered
within the expected range.
Of the respondents. 93.97, were men, 5.570
were women, and three or 0.07,, refused 10
state their sex. Ninety-five and nine tenths
percent of the respondents were while. Fne
respondents refused to state their rate. As the
icsponse rate was thus very low among the
nonwhile physicians in Davidson County, ihis
study provides no reliable information about
the influence of race upon physicians' alti-
tudes toward cadaver donation. Clearly the
largest percentage (G7.27„) of the respondents
were Protestant. A majority wcrcintci ns and
residents as is evident from the large number
(104) of individuals younger than 29. Half, or
50.77,. of the respondents were engaged in
nonsurgical specialties; 32.170 wcic engaged
in specialties requiring some singled pro-
cedures; and 17-2','n were engaged in other spe-
cialties or failed io answer (Tables 2 1).
Responses
The multiple choice answers to cadi of the
four basic questions described earlier were
arrangetl in dccicasing order from a most
favorable attitude to a least favorable attitude
toward cadaveric renal donation. In those cases
where the physician marked more than one
answer to a specific question, the answer show-
ing the most favoiable attitude was selected.
For analytical purposes, those opinions ex-
pressing belief that renal transplants aie effec-
tive or moderately effective were giouped
together; opinions that transplants would soon
or hail potential to be effective were grouped;
and negative opinions and refusals io answer
were grouped. Most tespondents (85.8%) be-
SOUTHIRN MEDICAL JOURNAL, APRIL 1975— Vol 68. No. 4
443
35
PHYSICIANS' ATTITUDES TOWARD ORGAN DONATION— Abram et al
TABLE 1
IR\N5rLANT QUESTIONNAIRE
Cfifal Information
I. Your age 2. ki-
V rate 4. id if
3. Present position (check one):
a. House staff
t>. Fulltime medical school faculn
c. Pi i vale praci.ee
U. Other
MciIh a I or surgical sr>cciali>-
\ears in practice
i'ni'c.itr Donation Infc matron
ft. 1 consider tcn.il transplantation using cadaver sili.guln (duck one):
a. An effective and pto\tn method or treatment
b A moderate!) effective mrtln>d of ireatment in selected caves
c. Still in the experimental stage but will toon become a pio\en method of iiejtmcnt
d. An efcpeiinuntal pro* r dure with poteniial for becoming a prnvrn method of treatment but some years
oil
e. A dangerous or use lets procedure of no clinical value
Concerning donating m> own ktdnos in th« event of death (check one):
a. I have signed and earn the Uniform Anatomical Cifl Act Caid
I Hould sign anJ cair> the Uniform Anatomical Gift Act Card if presi-nted to me— ■
1 vould hesitate but prub^blv sign such a card—
I would not sign such a card but do not feel upset at the thought that rov famil> might donate mv
kidnevi after mv death
e. Under no circumstances w-tiauortrr would I want my kidne)* used as cadaver organs
Concerning members of rm (ainiK donating their kidneys after death (check one):
a. Those of age have all signed the Anatomical Cifl Act Caid
b. I would encourage them lo sign stu h a card
C. 1 would be neutral on the matter of their signing a card, believing such a decision is a personal
I would discourage their signing a card but allow them to do wi if ibry pcrsisted-
1 would not allow them to donate their kidneys under am » iicumsianccs
Concerning patients who are under mv care (check one):
a. I would actively discuss the Anatomical Gift Act with ihem while they are in good health and encourage
them to donate their kidney* —
b If they ate moribund I would discuss the matter of donation with the patient's family and encourage
them to donate the kidneys after death
c. If ihey are moribund I would discuss the matter with the lamilv and tell them the kidneys could ho-
used without encouraging or discouraging them to make a decision one way or the other
d I would not discuss the matter with the family at all
e. I would forbid the family to allow donation even if thev Insisted to do »o — —
Comments: ,
lieved that renal transplantation is an effective Only 7.4% of the respondents had made pro
or moderately effective treatment (Table 5). vision for the donation of their organs (b>
The opinions on effectiveness were similar signing the Uniform Anatomical Gift Act
for all religions, for surgical vs nonsurgical card), although 54.1% or over half the respon-
specialties, and for all present positions (ie, dents indicated willingness to do so. Responses
house staff faculty, etc). Opinions on effective- indicating hesitance, refusal, dislike, or a re-
ness did differ, however, according to age. Of fusal to answer the question were grouped for
the physicians vounger than 40, 89.2% be- analytical purposes, all of these responses being
lieved transplan'ts to be an effective or moder- interpreted as a negauve attitude toward per-
ately effective treatment. The corresponding sonal donation of organs. The personal dona-
percentage for physicians 40 or older was "on status of the respondents was approxi-
82.2% The difference in these two percentages mately the same for all religions, for surgical
is statistically significant (p < .05). vs nonsurgical specialties, and for age (ie.
444 SOUTHERN MEDICAL JOURNAL, APRIL 1975— Vol 68, No. 4
36
PHYSICIANS' ATTITUDES TOWARD ORGAN DONATION-Ab-im e
I il
PHYSICIANS' ATTITUDES TOWARD ORGAN DONATION— Abtjm ct il
TABLE 2
ktur.ioM or RESPONDENTS
Religion
Protestant
Catholic
Je«*ith
Other .
"Christian"
Afnosiic
Albeit!
, None
Noi aniwered
Sumbet
JM
47
40
10
16
TABLE 4
PRESENT POSH ION
fr'frntagf
roution
Sumter
Trf«:
o: 2
Home ii iff
III
m
6 7
Faculty
1ST
iSS
7 4
Practice
C 1 1
389
16
Oilirt
41
M
30
Nn| jn-uned
1
•k
those younger than 40 as compared to those
older). The proportion who were already or
were willing to be donors did vary significantly
(p=<.02) according to the present position of
the respondent. House staff and faculty had
the largest proportions of positive responses
(70.9% and 63.5% respectively). Physicians in
private practice had the lowest proportion
(54.5%) who were already or were willing to be
donors. Respondents in positions other than-
house staff, faculty, or private practice respond-
ed positively 58.170 of the time (Table 6).
Sixty-one and six tenths percent of the re-
spondents expressed a neutral attitude about
members of their families being potential
donors. Only ten respondents said they would
discourage or forbid members of their families
from being potential donors. Responses con-
cerning family members did not differ signifi-
cantly with regard to the religion, specialty,
present position, or age characteristics of the
respondents (Table 7).
Those physicians who gave no answer to the
question concerning discussion of the Ana-
tomical Gift Act with patients or their families
were excluded from the analysis since their
TABLE 3
ACE OF RESPONDENTS
29 or younger
JO M
JS 39
40 44
45 49
50 54
55 59
60 64
65 69
70 74
75 +
Not aniwered
104
90
92
65
. 57
41
SS
25
9
I
6
192
16.6
17.0
12.0
10 5
89
65
4 6
1.7
15
I.I
0.6
number included many physicians who had,
little direct contact with patients. The propor-
tion of respondents (excluding those who did
not answer the question) who claim to dit-cuSS
the Gift Act with all (heir patients is 28.6/?
This proportion did differ significantly with
respect to age (p<.05), but not with respect to
present position, specialty, or religion. Fewer
respondents younger than 40 discussed the Gift
Act with their patients than older respondents
the percentages being 22.7% and 36.1«J re-
spectively (Table 8).
Discussion
The above findings point to some pielinu-
nary but noteworthy trends. The number of
physicians who have actually signed 'doiwr
cards is surprisingly small (7.4%), even though
a majority (54.1%) claim a willingness toAifn
a card if presented to them. Likewise, few phy-
sicians have family members who have signed
the Gift Act card (4.1%); another 31.7f, state
they would encourage ihcir family to do so
This finding suggests that accessibility of don-
or cards and increased public information nuy
improve the proportion of physicians and their
families who sign them. Several physician-
commented on the lack of information in
this area. As one stated, "The Anatomical
Gift Act card is a well kept secret from
the public and the medical profession at
large." After the completion of this study, the
State of Tennessee placed the statement.
"Organ Donor, Yes. . . No " on its driver >
TABLE 5
OPINIONS ON EFFECTIVENESS
Opinion
Effective
Moderately
Effective
Soon
Potential
Uaelea
Kot xniKcred
A urn 6c
204
261
si
S4
I
S.T
#J
p;
SOUTHERN MEDICAL JOURNAL, APRIL 1975— Vol 68, No. 4
445
37
fHYSICIANS' ATTITUDES TOWARD ORGAN DONATION-Abram ct al
TAILE 6
PLRSONAL DONOR STATUS
TABLE 8
DISCUSSION WITH PATIENTS
Slttuj
S
umcrr
rercrnl
fnyricianr' Answer
A umber
Fit, m,
Already
40
7.4
Discusi with all
143
264
Willing
29J
54 1
Disi iin with moribund
I9C
36 2
Hesitate
113
208
Discuss with family
127
234
Rrl»«
79
14 6
Not discuss
SI
5.7
Dislike
4
0.7
Forbid
Not inawrt
fd
19
24
Nor answered
'S
8 J
license. Such a move should increase signifi-
cantly the number of donors within the state.
It is also of note that those physicians in
house staff and faculty positions have a higher
proportion who are already or are willing to be
signers of the Gift Act card. These findings
may reflect that more exposure to transplant
programs stimulated interest and led to knowl-
TABLE 7
FAMILY DONOR STATUS
Already
Encourage
Neutral
Discourage
Forbid
Not inhered
A'umber
22
172
331
9
I
I'ercenl
4.1
31.7
61 I
17
0.2
1.3
edge of the need for potential donors. Al-
though \ounger physicians appear more
optimistic than older physicians concerning
transplantation as effective treatment, a small-
er percentage of them discuss the Anatomical
Gift Act with their patients. This finding mav
relate to the latter's greater life experience and
ease with patients, and perhaps to an accept-
ance of death not present in the younger
physician.
Reference!
I. Cleveland SE. Johnson DL: Motivation and readiness of
potential human tissue donors and nundonon. Piychoiom
Mid 32:225 231. 1970
2 Fellner CH. Schwartt SH: Altruism in disrepute : medical .
versus public attitudes toward the living organ donor. .V
Engl J Med 284 582 585. 1971
3 Tilrauss RM: The Gift Relationship, from Human llluo.l
to Socio/ Policy. New York, Pantheon DooLs. 1971
4. Cullen WH, Garrison CE: Factors influencing |..ichr.-
logical response to mailed questionnaires Health Srn> Rr;>
88 M0 514. 1973
♦46
SOUTHERN MEDICAL JOURNAL, APRIL 1975— Vol 68, No. 4
58
ATTACHMENT NUMBER TWO
CRITICAL CARE UNIT NURSE SUPERVISOR SURVEY
During the first quarter of 1981, the attached survey form was mailed to the
nursing supervisors of 6 emergency rooms and 12 intensive care units in 7 hospi-
tals in Memphis. Responses were received from the nursing supervisors of 2
emergency rooms (4 failed to respond) and 11 intensive care units (only one
failed to respond) in 7 hospitals.
Although the numbers involved in this survey were small, an insight was
gained into the perception of organ donation aspects by nursing supervisors
representing greater than 250 critical care nurses.
Question I. results indicated a reasonably good familiarity with hospital
policies concerning cadaveric organ donation. There appeared to be less cer-
tainty, however, when questioning whether staff were familiar with the policy
or whether procedures had been implemented to assure compliance.
The results of Questions II., III. and IV. are self-explanatory. The 10
"never" responses in Question V. would appear to be alarming until it is
realized that no patient's personal effects are retained in an intensive care
unit.
If the responses in Question VII., "most of the time" and "sometimes" are
read as "more than 50% of the time" and "less than 50? of the time", respec-
tively, then in about half the units responding the perception is that organ
donation is mentioned more than half of the time while in the remaining half of
the responding units organ donation is discussed with families in less than half
of the eligible cases.
Question VIII. refers to a bi-monthly newsletter produced and distributed by
the Transplant Coordinator to critical care nurses, physicians, social workers,
hospital chaplains and hospital administrators. The last issue was distributed
in May, 1982. Since that time, there has not been a single inquiry concerning
the whereabouts of subsequent issues.
Question IX. refers to a pamphlet designed to give to families of a patient
dying or deceased who is medically eligible for organ donation. This pamphlet
had been distributed previously to all 18 units surveyed.
Question X. is self-explanatory. Question XI. concerns itself with the matt
er of inservice educational seminars with critical care nurses in order to fami-
liarize them with the various aspects of their participation in organ procure-
ment. As a matter of practice, it is difficult if not impossible to be
permitted to provide inservice seminars in any critical care unit more often
than semi-annually. Obviously, if less than 50% of the nurses employed in a
unit attend each inservice seminar, it is not possible to acquaint all nurses
within any unit about organ donation within any year. Indeed, experience has
shown that less than 50% of the nurses in any critical care unit in Memphis have
ever attended an inservice program dealing with cadaver kidney donation.
The final question ties in with Question XI. demonstrating that rarely are
nurses afforded the opportunity to learn about organ donation.
39
Hospital Unit Name
N.A.=Not Answered
I. Does your institution have a policy regarding cadaver kidney donation?
Yes lQ No 3
A. If yes, have all your staff read the policy statement? Yes 6 No 4 N.A. 3_
B. If yes, has your unit implements procedures to assure compliance
within the policy statement? Yes 5 No 3 N.A. 5_
II. Does your institution have recommended criteria for brain death deter-
mination'' Yes 8 No 3 N.A. 2_
A. If yes, are staff and physicians attending within your unit aware of
Ihese criteria? Yes 8 No 0 N.A. 5
III. Is your staff aware of the death circumstances compatible with cadaver
kidney donation'' All are aware 1 Most 11 Some 1 None 0
IV. Is your staff aware of the medical suitability criteria for cadaver kidney
donation? All are aware 1 Most 10 Some 2 None
V. Does your unit search for a signed organ donor card on dead or dying
patients'' All of the time Q Most of the time 1 Sometimes 2 Never 10
VI. Who usually approaches the families of patients dying of a neurological
insult concerning kidney donation? Attending Physician 7 Nurse 3 Other
"Either" 3
VII. How frequently are the families of patients dying of a neurological insult,
Lut otherwise medically suitable kidney donors approached9
All of the time 0 Most of the time 6 Sometimes 5 Rarely 0 Never 1
"Unknown" 1
VlILDo you receive copies of the monthly U.T. Transplant Program Newsletter9
Yes 11 No 2
A. Does all your staff read these newsletters'' Yes 4 No 5 Most 1 Some 2^
N.A. 1
IX. Does your unit have a supply of "Gift of Life" pamphlets designed to give to
families of potential cadaver kidney donors? Yes 4 No 9
A. If yes, are all your staff aware of their placement in lhe unit7 Yes 3 No ^JN.A. 9
B. Also, if yes, how frequently are the pamphlets vised'' In every case 0
Most of Hie time Q Sometimes 4 Never 0
X. Ilov. would you describe the attitudes of your staff towards cadaver kidney
donation'' Favorable 9 Neutral_4_ Opposed 0
A. How would you describe the attitudes of most neurosurgeons attending
within your unit? Favorable 9 Neutral 3 Opposed 0 N.A. 1^
B. How would you describe the attitudes of other physicians attending patients
dying of a neurological insult? Favorable__7__Neutral 4 Opposed 0
N.A. 2
XI. When was the last time an inservice seminar concerning cadaver kidney donation
was conducted for members of your staff? < 3 mos. ago 3 3-Gmos. ago 1
tmos.-l yr ago 4_ > 1 yr. ago 4 "Probably Never" 1
A. What proportion of your staff attended the last inservice session'
< 10% 1_10%-20% 2 25%- 50% 3 50%-75% 3 75%- 100% 1_N.A. 3
XII. Do your new nurse orientation procedures provide a segment dealing with
cadavo.- kidnev procurement? Yes 4 No 9
40
Hoepital Unit Name
I Does your institution have a policy regarding cadaver kidney donation?
Yes _ No
A. If yes, have all your staff read the policy statement? Yes _ No
B. If yes, has your unit implements procedures to assure compliance
within the policy statement? Yes _ No
]i Does your institution have recommended criteria for brain death deter-
mination? Yes No
A. If yes, are staff and physicians attending within your unit aware of
these criteria? Yes No
HI. Is your staff aware of the death circumstances compatible with cadaver
kidney donation' All are aware Most Some None
IV. Is your staff aware of the medical suitability criteria for cadaver kidney
donation? All are aware Most Some None
V. Does your unit search for a signed organ donor card on dead or dying
patients' All of the time Most of the time Sometimes Never
VI. Who usually approaches the families of patients dying of a neurological
insult concerning kidney donation? Attending Physician Nurse Other_
VII How frequently are the families of patients dying of a neurological insult,
but otherwise medically suitable kidney donurs approached?
All of the time Most of the time Sometimes Rarely_
Never
No
'.ill. bo yuu receive copies of the monthly U.T. Transplant Program Newsletter"
Yes No
A. Does all your staff read these newsletters? Yes No
IX. Does your unit have a supply of "Gift of Life" pamphlets designed to give to
families of potential cadaver kidney donors9 Yes No
A. If yes, are all your staff aware of their placement in the unit' Yes_
II. Also, if yes, how frequently arc the pamphlets used'' In every case
Most uf the time Sometimes Never
X. llov. would you describe the attitudes of your staff towards cadaver kidney
donation? Favorable Neutral_ Opposed
A. How would you describe the attitudes of most neurosurgeons attending
within your unit? Favorable Neutral Opposed
II. How would you describe the attitudes of other physicians attending patients
dying of a neurological insult? Favorable Neutral Opposed
XI. When was the last time an inservice seminar concerning cadaver kidney donation
v,as conducted for members of your staff? < 3 mos. ago 3-6mo6. ago
( mos. - 1 yr ago > 1 yr . ago
A What proportion of your staff attended the last inservice session''
< 10% 10%-20% 25%-50% 50%-75% 75%- 100%
XII. Do your new nurse orientation procedures provide a segment dealing with
cadaver kidnev procurement? Yes No
41
ATTACHMENT NUMBER THREE
A STUDY TO IDENTIFY POTENTIAL ORGAN DONOR AVAILABILITY
During the period of April through August, 1981, in cooperation with the
Organ Procurement Unit of The Center for Disease Control, a study of the charts
of patients dying in 12 acute care hospitals during calendar year 1980 within a
15 mile radius of The University of Tennessee-Memphis was conducted in order to
assess the potential availability of organ donors.
' A chart reviewing instrument (containing this center's specific organ donor
medical acceptability criteria) was developed in concert with the C.D.C. Mr.
Michael Rich of the C.D.C. and Gary Hall, U.T. Transplant Coordinator visited
the various hospital administrators to obtain consent for the conduct of the
study. All hospitals agreed to participate.
The study was actually conducted by Gary Hall and was divided into four
phases: (1) Death Register Tabulations; (2) Patient Chart Review; (3)
Tabulation and Analysis of Chart Review Results; and (4) Report of Review
Results and Analysis to Participating Institutions.
l- Death Register Tabulation. In preparation for the actual chart review,
the Death Register for Emergency Room and In-hospital Deaths for each
of the 12 hospitals was reviewed. Patients dead on arrival were
excluded from the tabulations. Of the remainder, those deaths of
patients whose ages were less than one or greater than 59 years of age
were excluded. Finally, those deaths in which the Death Register noted
a cause of death (e.g. cancer, infection, etc.) which is a contrain-
dication to organ donation were excluded.
11 • Chart Review Results. Six hospitals were selected for inclusion in
this phase of the study. These six institutions accounted for 330
emergency room deaths and 4,463 in-hospital deaths or approximately 80%
of the total deaths tabulated from the 12 hospitals' death registers.
After the actual chart review was initiated, one of the hospitals was
eliminated from this phase when it was found that the patient charts
contained inadequate documentation to permit a reliable assessment of
any specific patient's medical suitability for organ donations. That
hospital's data (representing 110 emergency room deaths and 620 in-
hospital deaths) was then combined with the Death Register Data from
the six hospitals not selected for actual chart review.
The actual number of patient charts reviewed is indicated in the first
column of Section II. on the attached, "Chart Review Results" sheet. All 25
remaining emergency room death charts and 316 charts of patient dying after
admission to the hospital were reviewed (fourteen charts selected for review
were unavailable at the time of the review and another 57 charts from a single
institution were randomly selected out from the review since their inclusion
would have resulted in exceeding the preagreed limit of 150 charts for review
from a single institution).
42
Under the category of "Donors" in Section II. of the attached "Chart Review
Results" sheet are three columns which relate the chart review findings to
actual results in 1980. The "Identified" column denotes those deaths in which
the chart review found medically accepted brain-dead individuals (16 donors were
included in this column to account for the expected incidence among the 71
patient charts not reviewed). Charts of patients which had insufficient data or
in which there was not a clear indication of the existence of brain-death were
excluded. The "referred" column indicates the number of referrals of patients
who were medically acceptable for organ donation to the transplant program from
the five hospitals reviewed. The final column "Recovered denotes the number of
such referred patients who actually became donors.
The results obtained from the above review and tabulations were then applied
to the Death Register Tabulations from the other seven hospitals in which an
actual patient chart review was not conducted. These results were reflected in
Section II. a. of the attached "Chart Review Results" sheet.
Since there is no difference between the two groups of hospitals in terms of
the character of emergency room patient characteristics, a factor of 5% (the
proportion of E.R. deaths in Section II. found to be suitable for organ
donation) was applied to the E.R. deaths tabulated among the seven hospitals in
which the review was not conducted. In-hospital patient characteristics within
this qroup of seven institutions (with the exception of two hospitals repre-
senting a total of approximately 800 in-hospital deaths) is not the same as in
the five institutions actually reviewed. Accordingly, the proportion of in-
hospital deaths found to be suitable for organ donation 2.3+%) among the five
institutions actually reviewed was arbitrarily cut in half (1.2%) when applied
to the seven hospital group's data.
The resultant data included in Section III. (Combined Totals) is felt to be
a conservative assessment of the actual potential availability of donors among
the twelve acute care hospitals studied for calendar year 1980.
CONCLUSIONS: The incidence of medically acceptable cadaveric organ donors
in Memphis, lennessee, in calendar year 1980 was determined to be 140 (2.3% of
6 154 tabulated hospital deaths). During calendar year 1980 35 patients (an
estimated 25% of those available) who were medically acceptable for organ dona-
tion were referred to the Transplant Program. Thirteen patient fami les (37%)
refused organ donation with the result that 22 patients (63%) actually were
donors. The documented estimated referral efficiency (25%) does not account for
those cases where hospital personnel approached patient families about organ
domation, were refused and never therefore , contacted the Transplant Program.
However, candid conversations with key critical care nursing personnel support
the inescapable conclusion that a majority of suitable donors are never iden-
tified by attending hospital and medical staff and their families are not
advised of their right to donate.
43
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45
ATTACHMENT NUMBER FOUR
SURVEY OF CRITICAL CARE NURSES' ATTITUDES
TOWARDS ORGAN PROCUREMENT
A survey of critical care nurses' attitudes towards the various aspects
of organ donation and organ procurement was conducted during the late
autumn of 1982. Four hundred survey forms (a sample of which is attached)
were distributed through the unit nursing supervisors in 10 emergency
rooms and 18 intensive care units in 11 hospitals with instructions for
the form's completion and return of the surveys to Gary Hall, U.T. Transplant
Coordinator. One hundred Seventy-five completed surveys from 6 emergency
rooms and 7 intensive care units in 7 hospitals were returned. One
hospital (representing one E. R. and two intensive care units) refused
to participate. Effforts to retreive the surveys from the remaining 3 E. R.'s
and 9 intensive care units were abandoned after repeated attempts.
On the attached sheets are tabulated the responses in percentages for each
question. The last column tabulates the responses for all participants. In
the first four columns, responses are stratified according to the participants'
responses to two key questions- Question 4 under "Organ Donation Information"
("Attitude toward organ donation after my death") and Question 3 under "Brain
Death Information" hereinafter referred to as Question 3, Section II. The first
four questions are keyed as follows: Column I-those respondents who marked
"a" or "b" in Question 4, Section I and "yes" to Question 3, Section II;
Column II - those respondents who marked "a" or "b" in Question 4, Section I
and "no" on Question 3, Section II; Column III - those respondents who marked
"c" or "d" on Column 4, Section I and "yes" on Question 3, Section II; and
Column IV - those respondents who marked "c' or "d" on Question 4, Section I
and "no" on Question 3, Section II. The columnar percentages in each
question will not necessarily total 100% since the percentages listed
indicate the proportion of survey forms on which that choice was selected,
thereby accounting for more than one choice selected per question.
Analysis of the responses according to demographics has not been noted here
due to the following: (1) Age - no significant differences were found by
age grouping; (2) Sex - all but seven of those indicating their sex were
females; (3) Race - all but 12 of those indicating their race were white;
(4) Religion- all but 27 of those indicating their religion were Protestant,
and (5) Position - 141 of the 175 respondents were registered nurses.
A detailed analysis of the results will not be related here, but several
findings of importance and relevance will be noted. These findings suggest
that nurses' personal attitude toward organ donation and/or brain death do
impact on their willingness to participate 1n organ procurement. This conclu-
sion is confirmed by reviewing the results of the following questions:
(1) Question 2, Section I - under Column IV, 56% of the respondents
indicated they felt organ donation to be either valid only if the
patient has a signed organ donor card or "a fruitless and nonproductive
act."
46
(2) Question 3, Section I - about 90% of the respondents under columns I and
II (those with a favorable attitude toward personal organ donation) indicated a
willingness to take affirmative, independent action to encourage organ donation
with their patients or their families compared to only about 45% of the respon-
dents under columns III and IV (those with unfavorable attitudes toward personal
organ donation) who would take such action.
(3) Question 7, Section I - this question concerns the nurse's perception of
the frequency with which the families of patients under their care who are
medically suitable for organ donation are approached. The most distressing
finding is that 76% of all respondents indicated that families of potentially
eligible organ donars are approached "sometimes", "rarely", or "never"!
Another way of expressing this point is that three quarters of the nurses
perceive that less than half the eligible patients under their care ever
have an opportunity to become donors.
In addition to nurses' inhibitions to unequivocal participation in organ
procurement emanating from personal attitudes toward organ donation and
brain death, Question 9, section I indicates considerable uncertainty as to the
hospitals' postion with respect to organ donation. Although this fact does
not solely account for considerable uncertainty regarding eligible donor
identification (as determined from the responses to question 10 ( and 11),
it would seem to follow that if one is not sure of his employer's
position or support for a program, he is less likely to acquaint himself
with that program's needs and requirements.
Finally, the results of this survey do serve to reassure this transplant
program that their exists in Memphis widespread medical community support for
and participation in facititating organ donation. However, the survey confirms
our conviction developed from the previous hospital patient death chart
review that a majority of eligible donors are never identified and the
families not offered the organ donation option.
47
TABLUATED RESULTS
CRITICAL CARE NURSES' SURVEY
ORGAN DONATION INFORMATION
1.(80)
11.(30)
111.(22)
IV. (27)
TOTAL (175)
1. a.
41%
40%
23%
15%
33%
b.
60%
47%
77%
63%
58%
* c.
1%
10%
5%
7%
4%
d.
0
3%
0
11%
3%
n.a.
1%
0
5%
4%
3%
2. a.
69%
67%
50%
30%
58%
b.
20%
17%
32%
11%
21%
c.
10%
20%
14%
52%
19%
d.
0
0
0
4%
1%
n.a.
1%
0
5%
4%
3%
3. a.
39%
40%
14%
7%
26%
b.
48%
57%
32%
37%
41%
c.
34%
40%
68%
52%
34%
d.
1%
3%
5%
7%
3%
n.a.
1%
0
0
4%
5%
4. a.
70%
47%
_
_
42%
b.
30%
53%
-
-
24%
c.
_
_
64%
74%
22%
d.
_
_
36%
26%
10%
n.a.
-
-
-
-
3%
5. a.
64%
50%
32%
41%
51%
b.
28%
23%
9%
7%
19%
c.
10%
27%
50%
41%
25%
d.
0
0
9%
11%
3%
n.a.
0
0
0
0
1%
6. a.
38%
37%
18%
19%
30%
b.
52%
47%
59%
41%
52%
c.
6%
3%
9%
11%
7%
d.
1%
17%
9%
22%
8%
e.
30%
30%
45%
26%
34%
f.
25%
20%
23%
11%
19%
9-
4%
0
5%
4%
5%
h.
4%
0
5%
4%
3%
n.a.
1%
7%
0
0
3%
7. a.
1%
0
0
0
2%
b.
20%
3%
5%
4%
19%
c.
42%
47%
27%
15%
46%
d.
16%
40%
41%
44%
27%
e.
4%
7%
23%
41%
3%
n.a.
2%
3%
5%
0
4%
48
TABULATED RESULTS
CRITICAL CARE NURSES' SURVEY
ORGAN DONATION INFORMATION
1.(80) 11.(30)
111.(22)
IV. (27)
TOTAL (175)
8. a.
8%
13%
9%
19%
14%
' b.
4%
10%
32%
19%
12%
c.
2%
0
-
4%
2%
d.
5%
0
5%
4%
5%
e.
72%
70%
18%
30%
53%
f.
8%
3%
27%
22%
11%
n.a.
2%
3%
9%
11%
7%
9. a.
55%
47%
41%
26%
47%
b.
1%
3%
9%
7%
3%
c.
44%
50%
45%
63%
46%
n.a.
0
0
5%
4%
3%
10. a.
71%
40%
64%
33%
57%
b.
29%
60%
32%
67%
41%
n.a.
0
0
5%
0
3%
11. a.
68%
33%
55%
48%
54%
b.
30%
63%
41%
52%
41%
n.a.
2%
3%
5%
~
5%
BRAIN DEATH INFORMATION
1. a.
9%
3%
0
7%
6%
b.
66%
67%
73%
48%
63%
c.
24%
13%
23%
33%
22%
d.
0
3%
5%
15%
3%
n.a.
1%
13%
0
4%
7%
2. a.
69%
90%
73%
67%
69%
b.
19%
3%
27%
22%
17%
c.
0
0
0
0
0
d.
11%
7%
0
4%
9%
n.a.
1%
0
0
7%
5%
3. a.
100%
0
100%
0
59%
b.
0
100%
0
100%
34%
n.a.
0
0
0
0
7%
n. a. = not answered
numbers 1n parenthesis next to the column headings denote number of
respondents in each category.
49
Dear Colleague:
The maintenance of a viable organ retrieval program is essential in the effort
to meet the needs of the many victims of end-stage organ failure who'are currently
waiting for the chance to be transplanted in the greater Memphis region. Fundamental
to the success of this program is the willingness of acute care personnel to participate
in the referral of potentially suitable organ donor candidates. As a member of an
acute care team, your opinions and perceptions of the various elements involved in
solid organ donation are vitally important.
Attached is a confidential questionnaire designed to gather your impressions.
Please take a few brief moments to candidly give us your opinions and return the com-
pleted form to your unit supervisor. Your responses will be used to help us become
more aware of your satisfaction with the program and thereby help us to improve our
performance. Please feel free to add any additional comments or suggestions.
Thank you very much for your time and cooperation.
mA .
(ry^HalirVTransplant Coordinator
Renal/Hepatic Transplant Progran
SOLID ORGAN DONATION QUESTIONNAIRE
GENERAL INFORMATION
1. Your Age: 2. Sex:
3. Race: 4. Religion (optional)
5. Position (RN, LPN, etc.) "
6. Years in practice
7. Hospital:
8. Unit (e.g. 10th floor, ICU) :
ORGAN DONATION INFORMATION
(Please check only one response)
1. Cadaveric solid organ transplantation is:
a. Effective and proven.
b. Effective in selected cases.
A. Attitude toward organ donation after my
death:
_a. Organ Donor Card signed.
_b. Have not signed card, but willing to.
_c . Would not sign card, but idea of
donation acceptable if my family agi
_d. Opposed to organ donation after my
death.
_c. Experimental, but soon to be proven.
d. Dangerous, no clinical value.
2. I consider organ donation to be:
5. Concerning organ donation of a member of
my family:
_a. I have discussed organ donation with
them and am willing to follow their
wishes.
_b. I would be willing to donate their
organs even though I have not discussed
it with them.
_c. I have never thought about consenting
to organ donation for a family member.
_d. I would never donate their organs,
regardless of their intentions.
a. A valid and humanitarian act in
all eligible cases.
_b. A valid and humanitarian act for the
family even if patient's wishes unknown
_c. A valid and humanitarian act only if
patient has signed donor card. ~
_d. A fruitless and nonproductive act.
3. Concerning patients under my care:
(Check any)
_a. Would encourage them to sign organ
card.
_b. If moribund, would encourage family to
consent to donation.
6. The request of organ donation should be
made: (Check any)
a. In every eligible case.
_b. Only after the family accepts that the
patient will not survive.
_c. Only if family is not too upset.
_d. Only if family requests it.
_e. By patient's physician.
_f. By patient's nurse
_g. Only by a member of retrieval team.
h. Other
, _ 7. How frequently are the families of patients
c. Would refer such patients and families to
retrieval program for their guidance.
_d. Would never discuss matter with patients
or families nor refer them to organ ret-
rieval program.
under your care who are medically
eligible for donation approached?
a. Always; b. Most times;
_c- Some times; d. Rarely;
e. Never.
50
8. My Personal reservations about organ
donation are:
a. I may not really be dead when my
organs are removed.
b. I can't accept the idea of my body
being "cut on" after I die.
c.'l am dubious about the worth of
organ donation.
d. lire doctors will not be aggressive
-in treating while I'm alive if I'm
an organ donor.
e. No reservations.
~f. Other
9. Does your hospital have a policy regard-
ing solid cadaveric organ donation?
a. Yes; b. No; c. Don't know
10. Are you aware of the death circumstances
compatible with cadaveric solid organ
donation?
a. Yes; b. No.
)]. Are you aware of the medical suitability
criteria frr cadaveric solid organ donat-
io rib?
__a. Yes; b. No.
iil'.MN UKATH JNTOIIMATION (Check one)
]. The criteria physicians use in my hospital
to declare brain death are:
a. Absent respirations, fixed-dilated pup
ils, no response to painful stimuli.
b. Al] of ^. above and flat IXC's or
angiography.
c. Depending on circumstances, either a.
or b.
d.. No standard criteria.
2. The patient Jeclared brain dead should:
a. He removed from artificial support
only after the family consents to it.
b. Be removed from artificial support
without involving the family in the
decision.
c. lie treated aggressively regardless of
tiie family's wishes.
d. Other
J. In my opinion, it is acceptable to remove
a brain-dead donor's organs after the pat-
ient is declared brain dead and before the
heart stops beating:
a. Yes; b. No.
Comments and Suggestions:
51
Mr. Gore. I am going to hold my questions to the panel to a
minimum, and I would ask my colleagues to do so as well, because
of the doctor's travel plans.
First of all, just briefly, we are going to go into the specific sug-
gestions that you, Dr. Williams and you, Mr. Hall have provided to
us in detail later in this hearing today and tomorrow. But I want
to elicit from you two points.
First of all, Dr. Williams, your experience is that of a doctor who
spent, I believe, 6 weeks under Dr. Starzl and then came back and,
on your own, upgraded the skills that you learned in a relatively
brief time with Dr. Starzl and then implemented this new program
at the Medical Center in Memphis. That experience suggests that
we are likely to see a dramatic increase in the number of centers
and in the number of transplant operations in the next few years
all across the country. Is that correct?
Dr. James Williams. Yes.
Mr. Gore. As a result, the demand for transplantable organs is
likely to increase dramatically as well; is that correct?
Dr. James Williams. Yes.
Mr. Gore. And the experiences that Mrs. Hall has had and that
Captain Broderick has had are going to become quite commonplace
in the United States unless we figure out a way to respond to it on
a national basis; is that correct?
Dr. James Williams. Yes.
Mr. Gore. All right.
One of the hurdles that your patients face is money. You have
got the problem of paying for the operation, you have the problem
of procuring the transplantable organ, and you have the problem of
insufficient awareness on the part of the American people as to
how important it is for people to be willing to donate organs after
they die; correct? Those are the three hurdles?
Dr. James Williams. Yes.
Mr. Gore. In your case, Captain Broderick, you face that first
hurdle. Your child can't qualify as a candidate in this particular
program because you don't cross that first threshold. You don't
have a way to pay for the operation. You are an active-duty cap-
tain in the U.S. Army, and the U.S. Government refuses to pay the
amount of money necessary to save your child's life. Is that cor-
rect?
Captain Broderick. Yes, sir.
Mr. Gore. I find that really hard to believe. Without objection, I
would like to put into the record of this hearing a letter from the
Assistant Secretary of Defense, Dr. John F. Beary III, to you, Dr.
Williams, where he says a second consideration in denying approv-
al of this procedure is the fact that other federally funded health
programs, as well as other third-party payers, consider the proce-
dure to be investigational. An additional concern is the high cost of
the procedures, typically $50,000 to $60,000, versus the expected
long-range benefit to be derived.
[The information follows:]
52
ASSISTANT SECRETARY OF DEFENSE
WASHINGTON. D C 20301
0 4 WAR 1S63
JF_ ALTH AFf AIFU
James W. Williams, MD.
Associate Professor
The University of Tennessee,
Center for the Health Sciences
Memphis, Tennessee 38163
Dear Dr. Williams:
Lieutenant General Mittemeyer, in response to your December 3, 1982 letter,
has asked me to review our policy regarding coverage of liver transplants by
CHAMPUS. Although there is no question that there are patients who have
derived benefit from liver transplants,, there are several factors I have
considered which lead me to conclude that the procedure is still properly
classified as investigational.
First, there are very few facilities in the United States which have liver
transplant programs. Although the University of Pittsburgh, for example, has
had great success with liver transplants, a number of other facilities have
had high mortality rates in performing the procedure. Thus, since the
procedure cannot be readily replicated nor be provided with a predictable
level of success at a significant number of facilities, it does not meetTthe
"generally accepted standards of usual professional medical practice in the
general medical community" criteria required to be a covered service under the
CHAMPUS program.
A second consideration is the fact that other federally funded health programs
as well as other third-party payors also consider the procedure to be
investigational. An additional concern is the high cost of the procedure,
typically 450,000-60,000, versus the expected long-range benefit to be derived.
It is unfortunate that denying liver transplants as a covered service under
CHAMPUS will result in hardships on some of our service members. However, in
keeping with ray responsibilities as Acting Assistant Secretary of Defense for
Health Affairs, I cannot recommend that CHAMPUS benefits be expanded to cover
liver transplants until the procedure becomes more widely accepted and
practiced by the medical community. We must attempt to assure that high
quality care is provided to our beneficiaries in all situations.
I appreciate your concern in this matter.
F. Beary, III, M.D.
Acting Assistant Secretary
cc: Lieutenant General Mittemeyer
53
Mr. Gore. I share your reaction to that as repugnant, Captain
Broderick, and I will recommend at the conclusion of this hearing
today — not waiting for the committee report — that this subcommit-
tee immediately, as a subcommittee, call upon the U.S. Govern-
ment and the Defense Department who runs this CHAMPUS pro-
gram to immediately change its policy and allow for the payment
for this procedure. It is not investigational or experiemental. It is
necessary to save your child's life. I will ask my colleagues to join
in that recommendation later today.
Mr. Hall, it is true, is it not, that with so many patients, with so
many people needing organs to be donated, that the availability of
funds is a factor that institutions take into account — they must, of
necessity, take that into account; is that correct?
Mr. Gary Hall. That is correct.
Mr. Gore. As Mrs. Hall leaves and gets on the plane to fly back
to Memphis, Captain Broderick is still faced with the problem of
trying to pay for this operation. This really shouldn't be a consider-
ation for professionals such as you and Dr. Williams; is that cor-
rect?
Mr. Gary Hall. No, it shouldn't.
Mr. Gore. All right. I am sorry to rush through my questions,
but because of the time constraint, I wanted to do that.
Congresswoman Schneider.
Mrs. Schneider. Thank you.
I would like to know from any member of the panel if you are
aware of whether or not the American Medical Association or the
American Hospital Association is intimately involved in developing
uniform policy?
Mr. Gary Hall. We have no knowledge of that at this time.
Mrs. Schneider. And the AMA is not involved in a uniform
policy?
Dr. James Williams. Not that I am aware of directly.
Mrs. Schneider. It certainly seems to me that that is one good
place to start. I don't know that this body would be in a position or
even inclined to make mandatory requirements on the hospitals,
but it seems that you folks have certainly delineated how we could
get around this problem.
I am anxious to know how we in Congress might be able to assist
you, Mr. Hall, in improving the rate of donation of organs for
transplant surgery? Is there something we could do in this body?
Mr. Gary Hall. I thought about that. I don't know that any sort
of mandatory regulations are in order. I think that this body can
be influential in encouraging the various parties that have to coop-
erate in an organ procurement procedure to get together at a na-
tional level and at the various regional and local levels to try to
come to grips with solving the problems of oversight and omissions
that occur every day in this country, in that donors are not identi-
fied, and a family is not offered the option to donate.
Dr. James Williams. If I might add just one comment to what
Mr. Hall said, it is a problem of education, educating the public.
There is not a person in this group here who, when they die, there
will be any question about what happens to their organs. We know
what can happen. The general public doesn't know. The technology
has rapidly advanced. People who are now of child-bearing age and
54
of donor age were educated at a time when liver transplantation or
heart transplantation did not occur. So, the technology, I think —
the feasibility of doing these things has not been disseminated, it is
not understood. So it is clearly a matter of public education.
Mrs. Schneider. Obviously, the public media has an enormous
role to play, more so than the Members of Congress.
I am anxious also to know about your interpretation. How long
have we been transplanting livers, how many years?
Dr. James Williams. I would like to leave those questions to Dr.
Starzl, the person who is going to testify later. He is the father of
this effort. He has taken it from the very beginning and literally
pushed it into the position that it is today.
Mrs. Schneider. Very fine.
Most of my other questions, Mr. Chairman, have to do with the
medical aspects, so I will hold my questions for the next panel.
Mr. Gore. Fine.
Congressman Scheuer.
Mr. Scheuer. I will defer questions until the next panel, Mr.
Chairman.
Mr. Gore. Fine.
Mr. Scheuer. I do want to say that I deeply share your sense of
outrage and sense of deep concern about the posture of the Federal
Government in denying this life-enhancing and life-saving therapy
to patients who would otherwise die.
Mr. Gore. Congressman Durbin.
Mr. Durbin. I would just like to ask the panel in general if there
has been any effort or discussion about putting together regional
centers for coordination of hospital activities so that there will be,
at least on a regional basis, some sort of outreach to small commu-
nities and the medium-size hospitals that may not be aware of the
need?
Mr. Gary Hall. The organ procurement evolved as a result of
the need for kidney transplantation, and organ procurement that is
directed as close to home as possible has generally been found to be
the most effective. I don't know that there are any efforts afoot to
develop any regional programs, other than regional organ sharing
programs which will be addressed later.
Mr. Durbin. Thank you very much.
I will hold any further questions for the next panel.
Mr. Gore. Congressman Dan Glickman.
Mr. Glickman. Thank you, Mr. Chairman.
I would like to ask you if you think the Government should
engage in some sort of national data bank for disclosure of organs
for transplant? I understand there are regional networks, which
you touched on briefly, but perhaps Mr. Hall or somebody else may
want to talk about it. Should the Federal Government establish a
national coordinating information data bank for available organs
for transplant?
Mr. Gary Hall. I can't make a judgment on that.
Mr. Glickman. Is the existing system adequate? I understand the
southeastern area of the United States, and Florida in particular,
has a pretty good system.
Dr. James Williams. I think the problem is not in matching the
donor with the potential recipient. The problem is identifying and
55
getting the donor. Once the family has given permission for the re-
moval of those organs, from then on, the existing data banks, com-
puter banks, are able to match the suited recipient.
Mr. Glickman. Is there anything the Federal Government can do
to encourage donor participation?
Dr. James Williams. Those are the things that I am not by train-
ing equipped to say. I can identify the things I would like to have
done, but who does it, I
Mr. Gore. Would my colleague yield?
Mr. Glickman. Yes.
Mr. Gore. The third panel today is going to provide us with a
number of suggestions, some of which the subcommittee will be in-
cluding in its recommendations, I anticipate.
Following up on your question to Mr. Hall about a nationwide
system, how many separate organ procurement systems did you
contact in Brandon Hall's case, Mr. Hall?
Mr. Gary Hall. It was in excess of 30.
Mr. Gore. So you have to go to 30 separate organ procurement
networks in your search for an organ for this child.
How many organs are available for transplant but are unusable
because they don't get matched with a recipient in time? Isn't it
about 25 percent?
Mr. Gary Hall. That is true with kidneys. It is not quite that
high. But that is true with kidneys. I have no information relative
to other organs.
Mr. Gore. No figures on livers?
Mr. Gary Hall. Those that are actually excise and not used.
Mr. Gore. Presumably that percentage could be reduced if we
had one network instead of you having to search through 30 sepa-
rate networks; is that a reasonable assumption?
Mr. Gary Hall. The figure of 20 percent is really not an accu-
rate figure. Most of those organs that are discarded are not discard-
ed for lack of finding an available recipient, they are discarded for
other reasons. Only about a 5-percent figure is a more accurate
figure for organs discarded for lack of an available recipient at a
specific time.
Mr. Gore. I see.
Before closing, Mrs. Hall, I understand that three of Brandon's
nurses from LeBonheur Hospital paid their own way to come to the
hearing today with you and Brandon. Have you been receiving
pretty good medical treatment back in Memphis?
Mrs. Billie Hall. We always received good medical treatment at
LeBonheur. You wouldn't believe how good they are to us.
Mr. Gore. Captain Broderick, I understand that Adriane's case
has attracted the interest and attention of the White House, and
you have received some special attention there; is that correct?
Captain Broderick. I personally have not had any contacts with
the White House, sir.
Mr. Gore. I didn't ask that question to elicit that answer. It was
based on a mistaken assumption. I do know that they have an om-
budsman over there who works practically full time just on this
matter.
Dr. Williams?
56
Dr. James Williams. Yes; we have been in contact with Mr.
Battan, and it appears as though the President is very interested in
this problem and is applying pressure to CHAMPUS as well.
Mr. Gore. We are going to apply some pressure today. I hope and
expect a unanimous subcommittee action.
Let me thank all of you for helping in this effort to improve the
system for acquiring organs for transplantation.
We wish you good luck and God speed, Mrs. Hall and Brandon.
Mrs. Billie Hall. Thank you.
Mr. Gore. Captain Broderick, we will be doing everything we
possibly can to assist you in your continuing efforts on behalf of
your daughter, and also on behalf of other families around the
country that are in this same predicament.
Captain Broderick. Thank you very much, sir.
Mr. Gore. Thank you all.
Our next witnesses include some of the most distinguished doc-
tors in the entire world. With your indulgence, and you have al-
ready shown us a great deal, I must tell you that we have a vote on
the floor of the House. We will recess for approximately 6 minutes,
and then we will come back.
[Recess.]
Mr. Gore. The subcommittee will come back to order.
We are truly honored to have on this panel distinguished physi-
cians. Dr. Shumway and Dr. Starzl are truly the pioneers in their
respective fields, the leading transplant surgeons in their world.
Dr. Shumway almost single-handedly rescued the heart transplant
procedure from a disappointing start in another decade and made
it the life-saving procedure that it is today.
Dr. Tom Starzl single-handedly pioneered the liver transplant
procedure which, as we have heard, is becoming, if not common-
place, then certainly a regular part of medicine's ability to save
lives.
Dr. G. Melville Williams, in addition to being a distinguished sur-
geon, is the president of the American Association of Transplant
Surgeons.
To all three witnesses, let me extend on behalf of the subcommit-
tee our thanks for your willingness to come and join us in this
effort. We know it is most unusual for you, Dr. Shumway and you,
Dr. Starzl, to speak publicly. You are often too busy in the operat-
ing room and, for other reasons, you just don't speak out publicly.
We appreciate very much your willingness to come here — particu-
larly, Dr. Starzl, in light of the fact you were up all night. We don't
appreciate you any less, Dr. Shumway. But the fact that you were
willing to come here after having been up all night on a liver
transplant operation really testifies to your recognition of how
great the need is for this country to move forward.
Without further ado, Dr. Shumway, we will begin with you.
57
STATEMENTS OF NORMAN SHUMWAY, M.D., PROFESSOR OF SUR-
GERY, STANFORD UNIVERSITY SCHOOL OF MEDICINE, STAN-
FORD, CALIF.; THOMAS E. STARZL, M.D., PROFESSOR OF SUR-
GERY, UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE,
PITTSBURGH, PA.; AND G. MELVILLE WILLIAMS, M.D., PROFES-
SOR OF SURGERY, JOHNS HOPKINS HOSPITAL, BALTIMORE,
MD.
Dr. Shumway. Thank you.
I speak for the entire panel that we are grateful for this opportu-
nity to say a few things about the transplantation of tissues in
each of our particular specialties.
First, let me make a few general comments regarding the
present status of heart and heart-lung transplantation. I would like
then to focus on the somewhat special problems associated with
heart and heart-lung donors.
During the last decade, tremendous progress has been made in
the science and practice of transplantation. New drugs have
become available to control more effectively the immune response
to transplanted tissues. As a matter of fact, since we began the use
of cyclosporine A in December 1980, there has not been a single in-
stance of clinically diagnosable rejection of the allografted heart. In
other words, no patient has shown any signs of cardiac failure as a
result of the transplanted tissue. There are some deleterious side
effects of cyclosporine A, principally related to kidney function, but
the drug can now be synthesized, and its nephrotoxic properties
should soon be deleted from sister compounds.
The developing technology for organ preservation has widened
the pool of donors. Hearts can not be transported probably up to
2,000 miles with every expectation that the transplant will perform
satisfactorily immediately. Further work is progressing nicely in
this area of research, and the day will come when hearts can be
preserved to the same temporal limits enjoyed now by renal and
liver grafts.
Last year, in the United States alone, approximately 100 patients
underwent cardiac transplantation, 30 at Stanford. The 1-year sur-
vival rate now stands at 80 percent, and fully 90 percent of all pa-
tients having heart transplants at Stanford leave the hospital in
stable condition. This statistic contrasts markedly with the 22 per-
cent 1-year survival 15 years ago, which was the first year of clini-
cal heart transplantation at Stanford University.
Of 260 patients having cardiac transplants, 106 at Stanford are
alive and well now between 13 xk years and 2 weeks following the
procedure. Suffice it to say that transplantation of the heart is now
on the same therapeutic footing as kidney transplants. Medical
centers all over the world are re-entering the field, and many clin-
ics are producing results comparable to our own. This year, the
number of transplants should at least double last year's total with
further expansion to be expected later in the decade.
The hospital cost for a patient having heart transplantation at
Stanford is roughly twice that for a standard open heart surgical
procedure at Stanford. No professional fees have ever been charged
for any transplantation procedure, either heart or heart-lung.
58
Donor costs average $3,000 and are independent of whether the
donor is an on-site donor or in another hospital.
In the past, transplantation of the lungs have produced the most
dismal results of any kind of organ transplantation. Of 38 unilater-
al lung transplants, no patient lived as long as 10 months, and
most patients died within a few days to a few weeks after the pro-
cedure. Presently at Stanford, 8 of 11 patients having transplanta-
tion of both lungs along with the heart are alive and well, out of
the hospital and fully rehabilitated 2 months to 2 years after the
transplant. This complete turnaround in clinical results derives
from the concept of using the heart as the monitor of immunologic
events surrounding the transplanted cardiopulmonary axis. Actual
biopsy of the heart reveals precisely the status of the lungs with
respect to the host's immune reactivity, since the heart and lungs
are rejected pari passus.
Irrespective of any conceivable advance in artificial organs,
heart-lung transplantation is here to stay. The concept of a totally
implantable artificial heart with an inexhaustible, noiseless, non-
heat-producing energy source is one that we all respect, but its re-
alization is decades away. And anything man-made that could sub-
stitute for the entire cardiopulmonary axis is simply beyond con-
ceptualization. The early clinical results of heart-lung transplanta-
tion at Stanford are so gratifying that other centers are almost cer-
tain to develop their own programs. Twenty-one such transplants
have now been done worldwide, and next year we will see perhaps
another fifty.
California has a State law that declares the individual dead if
the brain is dead. The law wisely does not attempt to define brain
death, but it does consider the difference between brain injury,
even severe injury, and brain death. There are in use sophisticated
techniques for maintaining the function of other vital organs in
brain-dead individuals for extended periods of time.
At the University of California in San Francisco recently, a 27-
year-old brain-dead pregnant woman was maintained on a ventila-
tor with intravenous feedings for 2 months, with the delivery of a
3-pound, 31 weeks gestation live baby; life after death, as it were.
This remarkable case illustrates prolonged survival of the heart
and lungs in a brain-dead patient when appropriate care is given to
protect those organs from infection, atelectasis or collapse of the
lungs, and undue loss of circulatory volume.
At the outset of heart transplantation, many potential heart
donors were lost owing to medical and nursing neglect. Why put so
much effort into the care of patients who were already dead?
Through various educational programs and seminars where the re-
sults of transplantation of the heard and of the kidneys were dis-
cussed, intensive care units in most hospitals began to make the
necessary maneuvers to keep organs in transplantable condition.
The heart is the most prodigious consumer of oxygen of any organ
in the body, so its care in the potential donor must be precise and
thorough. Lungs are even more difficult to maintain in transplant-
able health. Teaching programs are now just starting in the San
Francisco Bay area to acquaint intensive unit personnel in certain
key hospitals with the essentials of pulmonary care in the potential
heart-lung donor.
59
With respect to donors, there are, of course, certain age restric-
tions. The youngest donor to be used for heart transplantation at
Stanford was 12 years, the oldest 51. Arteriograms are needed in
any donor greater than 35 years of age to rule out coronary artery
disease. In the State of California alone, there are 5,000 traffic
deaths each year. Not all or even a third of these are suitable for
donors, but the point is there are many more donors than are now
being utilized.
The public is, however, increasingly aware of the possibilities of
organ donation. In California, there are many renal transplant pro-
grams, and we collaborate with these centers to an extent that the
usual wait for a heart is no more than a few weeks. The delay for
an adequate heart-lung donor is much longer, but we hope to im-
prove the situation by our outreach training programs for intensive
care unit personnel.
In summary, then, transplantation of the heart is a proven
therapeutic intervention with a 5-year survival of at least 50 per-
cent, and 1-year survival rate that approaches 80 percent. Physi-
cians taking care of brain-dead individuals and the families of
brain-dead patients are becoming increasingly aware of the need
for transplantable organs. Additional programs are being inaugu-
rated to train health care personnel in the maintenance of various
organs in transplantable condition.
While there may be some future application for the artificial
heart as an interim device before transplantation, there is no such
mechanical substitute for the lungs, and the early results of trans-
plantation of the heart along with both lungs are even better than
for transplantation of the heart alone. So it is clear that the need
for adequate identification and care of donors is of tremendous and
ever-increasing importance.
Thank you.
Mr. Gore. Thank you very much, Dr. Shumway.
We will hold up on questions until the whole panel has complet-
ed its testimony.
[The prepared statement of Dr. Shumway follows:]
60
HEART AND HEART-LUNG TRANSPLANTATION
Norman E. Siwnmz* M&\ PhD
Professor and Chairman, Department of Cardiovascular Surgery
Stanford University School of Medicine
Stanford, California
FIRST, LET ME MAKE A FEW GENERAL COMMENTS REGARDING THE PRESENT
STATUS OF HEART AND HEART-LUNG TRANSPLANTATION. I WOULD LIKE THEN TO
FOCUS ON THE SOMEWHAT SPECIAL PROBLEMS ASSOCIATED WITH HEART AND HEART-
LUNG DONORS.
DURING THE LAST DECADE TREMENDOUS PROGRESS HAS BEEN MADE IN THE
SCIENCE AND PRACTICE OF TRANSPLANTATION. NEW DRUGS HAVE BECOME
AVAILABLE TO CONTROL MORE EFFECTIVELY THE IMMUNE RESPONSE TO
TRANSPLANTED TISSUE. AS A MATTER OF FACT, SINCE WE BEGAN THE USE OF
CYCLOSPORIN A IN DECEMBER OF 1980, THERE HAS NOT BEEN A SINGLE INSTANCE
OF CLINICALLY DIAGNOSABLE REJECTION OF THE ALLOGRAFTED HEART. TRUE,
THERE ARE SOME DELETERIOUS SIDE EFFECTS OF CYCLOSPORIN A, PRINCIPALLY
RELATED TO KIDNEY FUNCTION, BUT THE DRUG CAN NOW BE SYNTHESIZED, AND ITS
NEPHROTOXIC PROPERTIES SHOULD SOON BE DELETED FROM SISTER COMPOUNDS.
THE DEVELOPING TECHNOLOGY FOR ORGAN PRESERVATION HAS WIDENED THE
POOL OF DONORS. HEARTS CAN NOW BE TRANSPORTED PROBABLY UP TO 2000 MILES
WITH EVERY EXPECTATION THAT THE TRANSPLANT WILL PERFORM SATISFACTORILY
IMMEDIATELY. FURTHER WORK IS PROGRESSING NICELY IN THIS AREA OF
RESEARCH, AND THE DAY WILL COME WHEN HEARTS CAN BE PRESERVED TO THE SAME
TEMPORAL LIMITS ENJOYED BY RENAL AND LIVER GRAFTS.
LAST YEAR IN THE UNITED STATES ALONE APPROXIMATELY 100 PATIENTS
UNDERWENT CARDIAC TRANSPLANTATION, 30 AT STANFORD. THE ONE-YEAR
SURVIVAL RATE NOW STANDS AT 80 PERCENT, AND FULLY 90 PERCENT OF ALL
PATIENTS HAVING HEART TRANSPLANTATION AT STANFORD LEAVE THE HOSPITAL IN
61
STABLE CONDITION. THIS STATISTIC CONTRASTS MARKEDLY WITH THE 22 PERCENT
ONE-YEAR SURVIVAL 15 YEARS AGO, THE FIRST YEAR OF CLINICAL HEART
TRANSPLANTATION AT STANFORD UNIVERSITY.
ONE HUNDRED AND SIX OF 260 PATIENTS HAVING CARDIAC TRANSPLANTS AT
STANFORD ARE ALIVE AND WELL BETWEEN 13-1/2 YEARS AND TWO WEEKS FOLLOWING
THE PROCEDURE. SUFFICE IT TO SAY THAT TRANSPLANTATION OF THE HEART IS
NOW ON THE SAME THERAPEUTIC FOOTING AS KIDNEY TRANSPLANTATION. MEDICAL
CENTERS ALL OVER THE WORLD ARE REENTERING THE FIELD, AND MANY CLINICS
ARE PRODUCING RESULTS COMPARABLE TO OUR OWN. THIS YEAR THE NUMBER OF
TRANSPLANTS SHOULD AT LEAST DOUBLE LAST YEAR'S TOTAL WITH FURTHER
EXPANSION TO BE EXPECTED LATER IN THE DECADE.
THE HOSPITAL COST FOR A PATIENT HAVING HEART TRANSPLANTATION AT
STANFORD IS ROUGHLY TWICE THAT FOR A STANDARD OPEN HEART SURGICAL
PROCEDURE AT STANFORD. NO PROFESSIONAL FEES HAVE EVER BEEN CHARGED FOR
ANY TRANSPLANTATION PROCEDURE, EITHER HEART OR HEART-LUNG. DONOR COSTS
AVERAGE $3000 AND ARE INDEPENDENT OF WHETHER THE DONOR IS AN ON-SITE
DONOR OR IN ANOTHER HOSPITAL.
IN THE PAST, TRANSPLANTATION OF THE LUNGS, OF PULMONARY TISSUE, HAS
PRODUCED THE MOST DISMAL RESULTS OF ANY KIND OF ORGAN TRANSPLANTATION.
OF 38 UNILATERAL LUNG TRANSPLANTS NO PATIENT LIVED AS LONG AS TEN
MONTHS, AND MOST PATIENTS DIED WITHIN A FEW DAYS TO A FEW WEEKS AFTER
THE PROCEDURE. PRESENTLY AT STANFORD EIGHT OF ELEVEN PATIENTS HAVING
TRANSPLANTATION OF BOTH LUNGS ALONG WITH THE HEART ARE ALIVE AND WELL,
OUT OF THE HOSPITAL AND FULLY REHABILITATED TWO MONTHS TO TWO YEARS
AFTER THE TRANSPLANT. THIS COMPLETE TURNAROUND IN CLINICAL RESULTS
DERIVES FROM THE CONCEPT OF USING THE HEART AS THE MONITOR OF
IMMUNOLOGIC EVENTS SURROUNDING THE TRANSPLANTED CARDIOPULMONARY AXIS.
23-029 0-83-5
62
ACTUAL BIOPSY OF THE HEART REVEALS PRECISELY THE STATUS OF THE LUNGS
WITH RESPECT TO THE HOST'S IMMUNE REACTIVITY, SINCE THE HEART AND LUNGS
ARE REJECTED PARI PASSUS.
IRRESPECTIVE OF ANY CONCEIVABLE ADVANCE IN ARTIFICIAL ORGANS,
HEART-LUNG TRANSPLANTATION IS HERE TO STAY. THE CONCEPT OF A TOTALLY
IMPLANTABLE ARTIFICIAL HEART WITH AN INEXHAUSTIBLE, NOISELESS, NON-HEAT-
PRODUCING ENERGY SOURCE IS ONE THAT MUST BE RESPECTED, BUT ITS
REALIZATION IS DECADES AWAY. AND ANYTHING MAN-MADE THAT COULD
SUBSTITUTE FOR THE ENTIRE CARDIOPULMONARY AXIS IS SIMPLY BEYOND
CONCEPTUALIZATION. THE EARLY CLINICAL RESULTS OF HEART-LUNG
TRANSPLANTATION AT STANFORD ARE SO GRATIFYING THAT OTHER CENTERS ARE
ALMOST CERTAIN TO DEVELOP THEIR OWN PROGRAMS. TWENTY SUCH TRANSPLANTS
HAVE NOW BEEN DONE WORLDWIDE, AND NEXT YEAR WILL SEE PERHAPS ANOTHER
FIFTY.
CALIFORNIA HAS A STATE LAW THAT DECLARES THE INDIVIDUAL DEAD IF THE
BRAIN IS DEAD. THE LAW WISELY DOES NOT ATTEMPT TO DEFINE BRAIN DEATH,
BUT IT DOES CONSIDER THE DIFFERENCE BETWEEN BRAIN INJURY, EVEN SEVERE
INJURY, AND BRAIN DEATH. THERE ARE IN USE SOPHISTICATED TECHNIQUES FOR
MAINTAINING THE FUNCTION OF OTHER VITAL ORGANS IN BRAIN-DEAD INDIVIDUALS
FOR EXTENDED PERIODS OF TIME. ONE MIGHT IN POINT OF FACT ALMOST CONTEND
THAT THE DEFINITION OF DEATH TODAY MUST BE MADE IN TERMS OF AN ORGAN
SYSTEM THAT CANNOT BE TRANSPLANTED, I.E., THE CENTRAL NERVOUS SYSTEM.
OF COURSE PSYCHIATRISTS MIGHT TELL YOU THEY HAVE BEEN TRANSPLANTING THE
BRAIN EVER SINCE THE DAYS OF SIGMUND FREUD! AT THE UNIVERSITY OF
CALIFORNIA -HOSPITAL IN SAN FRANCISCO RECENTLY, A 27-YEAR-OLD BRAIN-DEAD
PREGNANT WOMAN WAS MAINTAINED ON A VENTILATOR WITH PARENTERAL OR
INTRAVENOUS FEEDINGS FOR TWO MONTHS, WITH THE DELIVERY OF A 3-POUND, 31
WEEKS GESTATION LIVE BABY; LIFE AFTER DEATH, AS IT WERE. THIS
63
REMARKABLE CASE ILLUSTRATES PROLONGED SURVIVAL OF THE HEART AND LUNGS IN
A BRAIN-DEAD PATIENT WHEN APPROPRIATE CARE IS GIVEN TO PROTECT THOSE
ORGANS FROM INFECTION, ATELECTASIS OR COLLAPSE OF THE LUNGS, AND UNDUE
LOSS OF CIRCULATORY VOLUME.
AT THE OUTSET OF HEART TRANSPLANTATION, MANY POTENTIAL HEART DONORS
WERE LOST OWING TO MEDICAL AND NURSING NEGLECT. WHY PUT SO MUCH EFFORT
INTO THE CARE OF PATIENTS WHO WERE ALREADY DEAD? THROUGH VARIOUS
EDUCATIONAL PROGRAMS AND SEMINARS WHERE THE RESULTS OF TRANSPLANTATION
OF THE HEART, AND OF KIDNEYS TOO, WERE DISCUSSED, INTENSIVE CARE UNITS
IN MOST HOSPITALS BEGAN TO MAKE THE NECESSARY MANEUVERS TO KEEP ORGANS
IN TRANSPLANTABLE CONDITION. THE HEART IS THE MOST PRODIGIOUS CONSUMER
OF OXYGEN OF ANY ORGAN IN THE BODY, SO ITS CARE IN THE POTENTIAL DONOR
MUST BE PRECISE AND THOROUGH. LUNGS ARE EVEN MORE DIFFICULT TO MAINTAIN
IN TRANSPLANTABLE HEALTH. TEACHING PROGRAMS ARE NOW JUST STARTING IN
THE SAN FRANCISCO BAY AREA TO ACQUAINT INTENSIVE CARE UNIT PERSONNEL IN
CERTAIN KEY HOSPITALS WITH THE ESSENTIALS OF PULMONARY CARE IN THE
POTENTIAL HEART-LUNG DONOR.
WITH RESPECT TO DONORS THERE ARE OF COURSE CERTAIN AGE
RESTRICTIONS. THE YOUNGEST DONOR TO BE USED FOR HEART TRANSPLANTATION
AT STANFORD WAS 12 YEARS OLD, THE OLDEST 51. ARTERIOGRAMS ARE NEEDED IN
ANY DONOR GREATER THAN 35 YEARS OF AGE TO RULE OUT CORONARY ARTERY
DISEASE. IN THE STATE. OF CALIFORNIA ALONE THERE ARE 5,000 TRAFFIC
DEATHS EACH YEAR. NOT ALL OR EVEN A THIRD ARE SUITABLE FOR DONORS, BUT
THE POINT IS THERE ARE MANY DONORS THAT ARE NOT NOW BEING UTILIZED.
THE PUBLIC IS, HOWEVER, INCREASINGLY AWARE OF THE POSSIBILITIES OF
ORGAN DONATION. IN CALIFORNIA THERE ARE MANY RENAL TRANSPLANT PROGRAMS,
AND WE COLLABORATE WITH THESE CENTERS TO AN EXTENT THAT THE USUAL WAIT
64
FOR A HEART IS NO MORE THAN A FEW WEEKS. THE DELAY FOR AN ADEQUATE
HEART-LUNG DONOR IS MUCH LONGER, BUT WE HOPE TO IMPROVE THE SITUATION BY
OUR OUTREACH TRAINING PROGRAMS FOR INTENSIVE CARE UNIT PERSONNEL.
IN SUMMARY, THEN, TRANSPLANTATION OF THE HEART IS A PROVEN
THERAPEUTIC INTERVENTION WITH A FIVE-YEAR SURVIVAL OF AT LEAST 50% AND A
ONE <:AK SURVIVAL THAT APPROACHES 80%. PHYSICIANS TAKING CARE OF BRAIN-
DEAD INDIVIDUALS AND THE FAMILIES OF BRAIN-DEAD PATIENTS ARE BECOMING
INCREASINGLY AWARE OF THE NEED FOR TRANSPLANTABLE ORGANS. ADDITIONAL
PROGRAMS ARE BEING INAUGURATED TO TRAIN HEALTH CARE PERSONNEL IN THE
MAINTENANCE OF VARIOUS ORGANS IN TRANSPLANTABLE CONDITION.
WHILE THERE MAY BE SOME FUTURE APPLICATION FOR THE ARTIFICIAL HEART
AS AN INTERIM DEVICE BEFORE TRANSPLANTATION, THERE IS NO SUCH MECHANICAL
SUBSTITUTE FOR THE LUNGS, AND THE EARLY RESULTS OF TRANSPLANTATION OF
THE HEART ALONG WITH BOTH LUNGS ARE EVEN BETTER THAN FOR TRANSPLANTATION
OF THE HEART ALONE, SO IT IS CLEAR THAT THE NEED FOR ADEQUATE
IDENTIFICATION AND CARE OF DONORS IS OF TREMENDOUS AND INCREASING
IMPORTANCE.
65
Mr. Gore. Dr. Starzl, I have already told you how much we ap-
preciate your being here. It really is an honor. Please proceed with
your testimony.
Dr. Starzl. Thank you, Mr. Gore.
I provided to the subcommittee copies of a written statement
which I won't read because I might fall asleep. What it really did
was to provide a summary for you of the developments in trans-
plantation, what has made this field possible, and it has really em-
phasized the kidney, which is the organ that has permitted the de-
velopment of the antirejection programs.
I was saddened to hear from Mr. Skeen of somebody who died in
1962, because that was the year when the great explosion occurred
with first use of Imuran and Prednisone together. And then the
subsequent landmarks have been 1966, which is the year that
triple drug therapy with antilymphocyte globulin [ALG] was intro-
duced in which ALG plus the other two agents was given in triple
drug therapy, and then, recently, as you heard, the cyclosporine-
steroid story.
Liver transplantation was first carried out, to answer a question
that you posed before, Congresswoman Schneider, in 1963, almost
exactly 20 years ago, the 1st of March. It is a procedure that has
prolonged life for many people, going back a number of years. The
oldest survival now is in the 14th postoperative year. I was a little
surprised this morning to see a young handsome teenage boy down
there, that redheaded boy at the end, who was treated 9 years ago
last Thanksgiving day. He broke up all of the Thanksgiving parties
going on.
Just as a parenthetical aside, you can't control the supply of
donors. I am sure Dr. Shumway has had the same experience. We
did Danny — who is from the Washington area — and then followed
him immediately with a young woman from San Francisco who has
subsequently had two children and who was sponsored by CHAM-
PUS. CHAMPUS paid for this procedure. By the way, the San
Francisco lady, the CHAMPUS symbol, is still living and still per-
fectly well. I think she is pregnant for the third time. Maybe that
is what induced them — CHAMPUS — to stop, I don't know. *
There are surgeons around the country, and many of them — Jim
Williams, whom you heard already, is a good example — who are
fully qualified to carry out liver transplantation. In fact, the Ten-
nessee group is an unusually good one because there are three
people down there who trained with us. One, many years ago, is
Lou Britt. Tom Peters spent 1 Vz years with us a few years ago. And
then there was Jim Williams, whom you heard today.
But why haven't they been able to function? The reason has been
this very problem of financing the cost of the enterprise. This is
really a big tragedy, because we have well-trained people capable
of carrying out liver transplantations all over the United States
who can't move forward. In fact, the people whom I have trained
have been able to function better and in the Far East and Europe
than they have in the United States.
I would like to look at the question of cost. It was an outrage to
Captain Broderick that a price tag should be put on his daughter. I
would like to look at the situation a little bit differently for those
who are only interested in money. Captain Broderick's child is in
66
the water. If he went into the sea and his rescue would cost $1 mil-
lion—we do it readily. He can't understand why his daughter who
is down can't be bailed out. But for those who don't believe that
kind of sentimental approach, there are studies out— one of them is
in process at the NIH which shows how much it costs to die from
end-stage liver disease.
I spoke to one of the officials at the NIH, whose name I think I
shouldn't disclose publicly because it would be a breech of confi-
dence, who told me that, to survive for 1 year after the first hem-
morrhage from esophogeal varices — which is one of the things that
happen to people with end-stage liver disease— the cost of survival
for insurance carriers or for the Government, or for whoever is
paying that bill, is $260,000, five times as much as a transplant.
In the American Journal of Surgery, in early 1981, there was a
study from Boston indicating that the cost of taking care of a pa-
tient who has bled the first time from an esophageal varix is
$57,000 if any kind of operation is needed. That is $57,000 down a
therapeutic cul-de-sac, because patients like that have no place to
go except the grave. The point is that it costs a lot to bury them,
far more — and perhaps as much as five times more— as it would
cost to save them.
What we are really getting to, I think, to crib a phrase that you
already used, we don't have the mechanisms of action in place. Jim
Williams, and perhaps some of the other people, with understanda-
ble bitterness have described how a ruling — not law — but some
kind of a guideline ruling by the medicare agency that liver trans-
plantation is experimental has been used as a refuge by cost-con-
scious HMO's and apparently by other Government agencies such
as CHAMPUS to avoid this responsibility. I think you are perfectly
correct in saying that there is powerful action being taken by the
White House to try to do something about that, as well as by
people in legislative bodies of both parties, to try to do something
about that situation.
Incidentally, I know for a fact that the same thing applies to car-
diac transplantation. The field has been distorted, or at least
caused to remain atrophic, because the same mechanism of denial
of payments for heart transplants has been used, it is experimen-
tal. That means that all of the Federal agencies deny payment on
those grounds. But the real problem comes when the cost-conscious
HMO's, the third-party private carriers say, "Well, look, the gov-
ernment has said it is experimental and we will not will not pay
because, if the Government says so, that must be so."
Mr. Gore. Dr. Starzl, let me interrupt you to say that it could be
changed administratively by the White House and by the adminis-
trators of these agencies. I might note for the record that, when we
started calling witnesses for this hearing, not long afterwards, we
heard back from NIH that they were going to schedule in June a
National Institutes of Health consensus development conference to
try to change this.
I think we have a bioethical imperative to change it even before
then. For patients in the condition of Captain Broderick's daughter,
we shouldn't have to wait for a conference 2 months from now. She
may not make it that long.
Excuse me for interrupting.
67
Dr. Starzl. I am glad you did. I think it is important.
People from all levels and from many agencies have been really
anxious to have the consensus development conference go forward.
I am personally anxious to have one go forward for hearts. I was
with your people, as you know, Norm Shumway, on that white
paper conference that developed a position in 1980, which actually
almost had the opposite effect of what we had hoped. It almost stul-
tified the growth of cardiac transplantation instead of helping it.
So I think this other avenue, which is really an effort to assure
third-party insurance carriers that this is a service, is probably a
better one rather than depending on government funding.
But the point that I was trying to make is that well-meaning
people in government can sometimes be the means by which a
shield, is created which prevents other private agencies from
taking up the burden.
The same thing applies to organ procurement. That is the point
that I really want to get to. As I am sure you will verify, there is
no visible means of support to get extra-renal organs. There is no
way to pay for hearts. There is no way to pay for livers. There is no
way to pay for pancreases or heart-lungs.
What we have done — and because some of us, Mel Williams and
I, have been in the kidney field for 20 years — is to call back old
debts from many people and to develop networks, professional net-
works, just talking amongst ourselves and we have been able to en-
graft our efforts upon existing renal programs which are funded
from Federal sources.
Here, also, there can be the stultifying effect of Government, be-
cause— and I think I got this information from Mel Williams about
a year ago, there was a letter sent or some kind of a for-your-infor-
mation document sent out from Aetna, which is the carrier for the
end-stage renal procurement program. It was a kind of a warning
to the transplant coordinators and to the renal transplant surgeons
who were out getting organs. It had some flash phrases, including
the fact that they had to understand that if they collaborated with
Norm Shumway and with me and others, there was no liability
coverage, for these extra-renal organs. And second, that they were
not covered for the expenses of the other organs.
There was another thing, too, that was very important. I think it
says something about the courage of the transplant coordinators,
whom you will be hearing from. They lost their personal liability
coverage. So as they ran around the country in small planes, if
something happened to them in the course of going out for livers or
hearts, they were not covered. This was all stated in the document
that went around. It really had a chilling effect on the transplant
coordinators.
Mr. Gore. Dr. Starzl, without objection, I would like to put that
document to which you refer in the record at this point.
I would like to clarify the record that, when you refer to extra-
renal organs and the problem you are discussing, you are talking
about a situation where kidneys are harvested from a donor, and
the other organs such as the heart, the liver, and the lungs, are not
retrieved for those who need them sometimes because there is no
funding mechanism for that retrieval.
68
Dr. Starzl. Or because there is resistance from people who fear
the consequences.
Mr. Gore. Including the lack of insurance and the warning from
the carrier of the national kidney program that they will lose their
insurance coverage if they retrieve other organs in addition to the
kidney.
Dr. Starzl. There was a such a document, yes. I think that is an
accurate summary. We can easily get that for you.
Mr. Gore. It is in the record at this point.
[The information follows:]
69
medicare
bulletin
OP-81-6 --- October 1, 1981
PRODUCT LIABILITY AND
MALPRACTICE COVERAGE
PRIMARY INTEREST: ORGAN PROCUREMENT AGENCIES
In June of this year Aetna informed all IOPAs by letter of
a potentially serious problem concerning the procurement of
organs other than kidneys. Our concern was with the costs
of a lawsuit which originated from the OPA's involvement in
procuring organs other than kidneys. Hopefully, you have
reviewed your specific situation with your Board of Dir-
ectors, Attorney, and Insurance Agent.
The Health Care Financing Administration - End Stage Renal
Disease has given us a policy decision on this issue. The
following paragraphs are their reply.
If the OPA has product liability and malpractice coverage
the Medicare Program will reimburse the cost of this insur-
ance. If you are named a party to a lawsuit which resulted
from the retrieval of tissue or an organ other than a
kidney the costs of legal fees, settlements and related
costs would not be reimbursed by Medicare.
If the OPA does not have product liability and malpractice
coverage the Medicare Program will reimburse the OPA for
legal fees, settlements and related costs for claims
arising from the retrieval of kidneys. This does not
include physician professional coverage for the procurement
of the kidney. However, should a lawsuit develop from
activity performed in the retrieval of any tissue or organ
that is not a kidney, the Medicare. Program will reimburse
none or these expenses.
Continued on the back
MR-68526
LIFE 8. CASUALTY
70
Therefore, if you have not already done so, we recommend
that you evaluate the possibility of these events taking
place with your Board of Directors, Attorney and Insurance
Agent. The range of options are:
1. After your evaluation you believe the risk to be
minimal and continue to retrieve other organs without
coverage .
2. You obtain product liability and malpractice coverage
for all organs and tissue.
3. You obtain an agreement with the other organization
(eye bank, skin bank, etc.) to assume the potential
liability.
4. You cease providing any services related to other
organs .
5. A variation of the above.
If we can be of assistance please contact Aetna at (203)
273-3999.
TA/tp
/Etna Life Insurance Company
Medicare Administration - M101
71
Dr. Starzl. I think that the reason that things have gone for-
ward as they have— and I am sure that Norm Shumway will verify
this as well— the reason that things went forward is that kidney
transplanters who have a big network, and maybe especially the
transplant coordinators, made this a crusade. The transplant coor-
dinators have discussed it at their meetings. They have asked me
and others, and we have willingly gone to participate, in their na-
tional meetings and to tell them how we can put aside some of
these objections to the procurement of extra-renal organs.
As a matter of fact, as you have heard from the coordinator, Mr.
Hall, from Tennessee, they — the coordinators — have themselves set
up this 24-Donor System which is an 800 number. This donor that
you heard about this morning came from that 800 system. Mr. Don
Denny, whom you will be talking to later, set up the 24-Donor
System. It is the most effective system that I know of. It covers the
country.
Solutions— I think if the barriers were removed that are imposed
by the existing guidelines, it would be an enormous step forward. I
think we ought to face squarely the fact that this is a new epoc.
What you said this morning, Norm, and what we have both said in
print, is that the decade of the 1980's is going to be remembered, I
think, as the time when transplantation really came to full fruition
and realizes the promise that did not materialize in the 1960's
when we all started in transplantation.
If we recognize that and if we remove these guideline barriers to
the implementation of programs— the programs will spring up. I
think there will be many liver programs if this consensus confer-
ence goes forward positively, and I am guessing 20 to 30. We are
very busy training people, or refreshing people who are already
trained, so that they can set up programs. I won't embarrass the
centers by mentioning their names, but there must be already
around 12 that are ready to go.
We have to carry out intensive education efforts, and we are
really trying to do that through journals. I think we have to reach
the physicians. Mr. Denny wrote, at their request, an editorial
about pediatric donor procurement for the Journal of Pediatrics
which will be coming out soon. But maybe especially we have to
educate lay people.
The figures that we have heard about, the low percentage of do-
nations amongst the black population— it is tragic if it is true. As
we heard last week at another meeting, the incidence of renal dis-
ease amongst the black population is higher, not lower, than in the
population in general, so there is a greater need for organs, not
less. Thus, there should be a stronger incentive than normal to
create attractive donor programs amongst blacks.
The 24-Donor System which I have mentioned, may not be the
final prototype, but it is a good prototype to start from because it
just started on its own in response to need.
I think to develop some way of bringing the extra-renal organs
on a level of parity with the kidney is quite important. The kidney
procurement programs are funded by the end-stage renal disease
program as a free-standing program and, somehow, it needs to be
written into law, I think, that other organs are needed and are per-
haps an even more priceless resource.
72
Mr. Gore. Thank you very much, Dr. Starzl. We will hold up on
questions.
[The prepared statement of Dr. Starzl follows:]
73
TESTIMONY:
THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
Organ transplantation including transplantation of the kid-
ney has been a realistic possibility only since 1962 when mul-
tiple agent therapy was first standardized. The first break-
through was in 1962 with the combined use of two drugs called
Imuran and Prednisone, to which a third agent called antilyrapho-
cyte globulin - - or ALG - - was added in 1966.
Using the double drug or triple drug combinations, accept-
able results became possible with renal transplantation between
family members. In contrast, the national average for one-year
kidney survival after renal transplantation using cadaver donors
has only been about 50 percent. Even such limited successes have
depended upon the use of high doses of steroids. The steroids
have such severe side effects that many centers exclude older-
patients from consideration for kidney transplantation, and in
some of the European contries no one over the age of 60 is admit-
ted for consideration.
Obviously, the transplantation of other organs including
those of the GI tract - - the liver, intestine, and pancreas - -
but also including the heart and lung must be from cadaver don-
ors. Thus, the same limitations imposed by suboptimal drug
treatment have inhibited the development of transplantation of
these other organs, including those of the GI tract. For almost
20 years, there seemed no way out of the dilemma. The drugs
being used were, on the one hand, unreliable in preventing rejec-
tion, and on the other excessively dangerous.
74
In 1976, Dr. Jean Borel, a basic scientist working at the
Sandoz Corporation in Basel, Switzerland, discovered and charac-
terized a new immunosuppressive drug called cyclosporine. This
drug was released for limited clinical trial in Britain in 1978,
and in 1979 it became available in the United States at two cen-
ters, including ours.
We realized almost from the outset with cyclosporine that
prednisone could be used in much smaller quantities than at any
time in the past, that rejection control was better, and with a
smaller risk to the patients.
Even during our learning phase (in 1980) the one - year
cadaver kidney survival rose to 80 percent. Our subsequent ex-
perience at the University of Pittsburgh On 1981) resulted in a
one - year cadaver kidney graft survival of greater that 90 per-
cent. The patient mortality in the first year of our Pittsburgh
trials was less than one percent.
Almost from the beginning of cyclosporine use, many of the
contraindications to kidney transplantation have been softened so
that people previously excluded because of advanced age or other
disease have now been accepted as candidates.
It was natural to extend this major advance in therapy to
recipients of other organs. The first trials with liver trans-
plantations under cyclosporine were begun in early 1980, 3 years
ago. The one - year liver graft and patients survival was twice
that achievable in previous times, ranging 65 - 70*. These re-
sults have been so encouraging that at the Unversity of Pitts-
burgh liver transplantation is now considered a service as op-
75
posed to an experimental procedure. We carried out 82 liver
transplantations in 1982, almost fo~u'r times the yearly number
ever previously possible in our nearly 20 years of work in this
field. In 1983, we expect to do more than 100.
The cyclosporine - steroid combination has also been used
since early 1981 both at Stanford University and at the Univers-
ity of Pittsburgh for heart transplantation.
The implication of these improvements in drug therapy are
apt to have a profound effect on health care delivery as this
applies to transplantation. In renal transplantation, the inter-
face between dialysis and transplantation will be drastically
altered when cyclosporine becomes generally available, and this
with a great cost savings to the tax payers who pay for the $2
billion a year end - stage renal disease program.
The wider application of transplantation techniques to peo-
ple with failure of the liver, heart, pancreas, intestine, and
other organs is a clinical reality today and now. It is likely
that cost savings can be engendered here also as well as provi-
sion of better health care. These developments will be dependent
on improvements of cadaveric organ procurement.
76
0270-9139/82/O2O5-0614$O2.0O/0
Hepatoloc*
Copyright © 1982 by the American Association for the Study of Liver Diseases
Vol 2, No 5, pp 614-6.36, 1982
Printed in USA
Evolution of Liver Transplantation
Thomas E. Starzl, Shunzaburo Iwatsuki, David H. Van Thiel,
J. Carlton Gartner, Basil J. Zitelli, J. Jeffrey Malatack, Robert R. Schade,
Byers W. Shaw, Jr., Thomas R. Hakala, J. Thomas Rosenthal, and
Kendrick A. Porter
Departments of Surgery, Medicine, and Pediatrics, University of Pittsburgh Health Center,
University of Pittsburgh, Pittsburgh, Pennsylvania 15261 and the Department of Pathology,
Saint Maiy's Hospital and Medical School, London, England
Two general kinds of liver transplantation have been
attempted clinically. With one approach, the host liver is
removed and replaced with a homograft (orthotopic liver
transplantation); alternatively, an extra liver is inserted
at an ectopic site (auxiliary homotransplantation). This
review concerns only orthotopic liver transplantation.
The first effort to replace a human liver was made at
the University of Colorado on March 1, 1963. That pa-
tient died as did four others during the next 7 months (1,
2) (Table 1). In September, 1963 and January, 1964, other
unsuccessful attempts at liver replacement were made in
Boston (3) and Paris (4) (Table 1). The first clinical trials
were not frivolously undertaken. Members of the Boston
and Denver teams had developed techniques for liver
replacement in dogs in the late 1950s and, in both labo-
ratories, research on liver transplantation had been con-
tinuously performed for more than 4 years.
Nevertheless, the consecutive failures in three institu-
tions halted all clinical trials until our sixth and seventh
equally unsuccessful attempts in October, 1966 and May,
1967. Finally, on July 23, 1967, the first extended survival
of a human recipient was achieved (5). The patient, a Vh-
year-old girl, lived for more than 13 months before dying
of metastases from the hepatocellular carcinoma for
which she had been treated. From then until the first
week of May, 1982, we have treated 230 more patients,
163 at the University of Colorado and 67 at the University
Health Center of Pittsburgh for a total of 237. The yearly
frequency of transplantation throughout our experience
is shown in Figure 1. The highest number of 30 was
reached in 1981; the number of new cases in 1982 is
projected at between 60 and 80.
A signal event in the development of orthotopic liver
This study was supported by grants from the National Institutes of
Health (AM 17260, AM-07772, AM-29961, and AM-30183) and from
the General Clinical Research Centers Program of the Division of
Research Resources, National Institutes of Health (RR0O051. RR-
00069, and RR-00084).
Address reprint requests to: Thomas E. Starzl. M.D., Ph.D., De-
partment of Surgery, University of Pittsburgh. 1084 Scaife Hall. Pitts-
burgh, Pennsylvania 15261.
transplantation occurred on May 2, 1968 when Calne and
Williams of the University Hospital at Cambridge and
the King's College in London, respectively, treated the
first patient in their program (6, 7) which had since
generated more than 125 well-studied cases. Calne's con-
tributions in experimental renal transplantation has been
a major factor in the early development (8) of chemical
immunosuppression, without which transplantation of
any organ was not realistic until 2 decades ago. The fact
that both men had the personal qualities to be able to
accept defeat or victory with equal grace was fortunate
since failure was the dominant theme with all such efforts
until recent times.
In this review, emphasis will be placed on the more
than 350 cases in these two series. However, between
1968 and 1978, other single attempts or small series were
reported from Boston (9, 10), Los Angeles (11), Montreal
(12), Bonn (13, 14), Sao Paulo (15), Calgary (16), New
York City (17), Richmond (18), Minneapolis (19), Man-
chester (20), and Oslo (21). It is probable that these
documented cases were a minority of those attempted in
that decade, exclusive of the English and Colorado series.
Since 1978, programs have been reopened or started new
from which important information can be expected. -In
the United States, clinical liver transplantation programs
are active at the University of Minnesota (J. S. jNajarian,
unpublished observations) and the University of Tennes-
see (J. W. Williams, unpublished observations). Series of
six or more cases each have been reported or are in
preparation from Holland (22), East Germany (23), West
Germany (24, 25), France (26), and the Republic of China
(H. Q. Hong, unpublished observations). The number of
cases in the West German series (25) has passed 50, but
the results have not yet been published in detail.
EARLY EXPERIMENTAL BACKGROUND
The first known efforts at experimental orthotopic
transplantation of the liver were made by Dr. Jack Can-
non of Los Angeles (27). This report was so brief that it
lacked a title, description of methods, and notation of the
animal species. The animals did not survive operation.
614
77
Vol.2. No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
615
Table 1 The First Trials of Orthotopic Liver Transplantations
Location
(ref.)
Age
lyrl
Survival
(days)
Main taiise of death
1
Denver (1)
3
Extrahepatic biliary atresia
0
2
Denver (1)
48
Hepatocellular cancer, cirrhosis
22
3
Denver (1)
68
Duct cell carcinoma
IV,
4
Denver (2)
52
Hepatocellular cancer, cirrhosis
&A
5
Boston (3)
58
Metastatic colon carcinoma
11
6
Denver (2)
29
Hepatocellular cancer, cirrhosis
23
7
Paris (41
75
Metastatic colon carcinoma
0
Hemorrhage
Pulmonary emboli, sepsis
Sepsis, pulmonary emboli, gastrointestinal
bleeding
Pulmonary emboli, ? hepatic failure, pul-
monary edema
Pneumonitis, liver abscesses, hepatic failure
Sepsis, bile peritonitis, hepatic failure
Hemorrhage
; j flelransplantation
I Primary Ortholopic Ttansplanlahon
n ill.
63 64 65 66 67 I
I 69 70 71 72 73 74
YEARS
5 76 77 76 79 80 81 82
Fig. 1. Yearly number of liver transplantations at the University of
Colorado (1963 to 1980) and the University of Pittsburgh (1981 to
1982) Note that retransplantation has been attempted frequently.
In June, 1958, a program of orthotopic transplantation of
the canine liver was initiated at the Peter Bent Brigham
Hospital under the direction of Dr. Frances D. Moore
(28), and in August, our first experiments in the same
species were begun at Northwestern University in Chi-
cago (29, 30).
The technical problems of liver replacement and the
features of rejection in untreated canine recipients were
delineated (28-31). Eventually, using immunosuppres-
sion with azathioprine (32-34) and antilymphocyte serum
or its antilymphocyte globulin (ALG) derivative (32,
35-38), chronic survival was achieved in mongrel dogs of
which one lived for almost 12 years (39).
In 1965, Gamier of Paris (40) made the important
observation that rejection of pig liver homografts was
mild in comparison to that in dogs. Several porcine
recipients lived for long times without immunosuppres-
sion. Workers in Bristol (41), Cambridge (42), and Denver
(32) promptly confirmed Garnier's work. The value of
the pig for transplantation research has been demon-
strated frequently in the investigations of Calne and his
associates.
Hundreds of significant experimental studies in various
species have since been published. Review of this work
will not be attempted although some of it has influenced
the clinical trials as will be noted later.
NOTATIONS ABOUT SURGICAL TECHNIQUES
IN HUMANS
A training period in the animal laboratories is an
important preparatory step for teams planning clinical
programs; however, not all of the experimental tech-
niques are identical in humans. Our methods of ortho-
topic liver transplantation (1, 5, 32, 43-52) and the mod-
ifications introduced by Calne et al. (6, 47, 53) have been
described.
The operation is simple in principle (Figure 2), but its
execution has been exceptionally difficult because of the
almost invariable debilitation of the recipients and the
profoundly abnormal vascularization patterns caused by
portal hypertension in endstage liver disease. Defects in
clotting have been present in most cases (1, 32, 54, 55),
and adhesions or other alterations secondary to previous
operations are often complicating factors. With such a
background, it is not surprising that the postoperative
care of many patients has been an exercise in resuscita-
tion (32). The most common difficulties have been pul-
monary insufficiency (requiring mechanical ventilation
for several months in some cases), renal failure with
massive fluid shifts, and persistent clotting abnormalities.
These problems are managed with conventional methods
of intensive care with emphasis on biochemical and he-
modynamic monitoring. Recovery can be expected from
encephalopathy and the hepatorenal syndrome (56).
The ability to survive this critical period depends upon
what has transpired in the operating room. Thus, in the
following remarks, we will touch upon details of surgical
technique which require reemphasis or points of view
which have changed from those expressed in the past.
Organ Procurement and Preservation
Until 1976, techniques for preserving the liver either
severely limited the acceptable time of cold ischemia or
were too complicated for use in outlying hospitals (32).
In 1976, simple methods that permitted reasonably long
storage were developed, and clinical trials were started.
We have employed an electrolyte (Collins) solution with
a composition similar to that found intracellularly (57).
The Cambridge-King's College team uses a plasma so-
lution for similar cold infusion of the homograft (58). In
dogs, the two methods yielded similar results (57) and
allowed safe preservation for up to 12 hr These tech-
78
316
STARZL ET AL.
Hepatolo<;y
Fig. 2. Completed orthotopic liver transplantation (A) Biliary tract reconstruction with choledochorholedochostomy. (B) Biliary tract
reconstruction with choledochojejunostomv. using a Roux limb.
niques permit shipment of livers from city to city. More
than two-thirds of the livers used in the Pittsburgh
program have been obtained outside of the normal pro-
curement area for this region; the longest transit being
from Phoenix, Ariz. Efficient air travel arrangements are
necessary; to meet this objective, several Pittsburgh cor-
porations have donated their private jet airplanes.
Liver procurement outside of the local area has de-
pended on cooperation with other procurement centers
whose main function was previously to provide cadaveric
kidneys. Fear that kidney grafts would be jeopardized by
giving too high a priority to the liver has been allayed by
standardization of techniques which protect all organs
equally and which can be adapted to the local surgeons'
wishes (59).
A midline incision is made from the pubis to the neck,
and the sternum is split. The structures entering and
leaving the liver are skeletonized, and the necessary
preliminary steps for kidney removal are taken in the
presence of an intact circulation. Then a cannula is
placed through the splenic vein into the superior mes-
enteric vein. Rapid infusion of cold lactated Ringers'
solution is used to start cooling of the liver. After 1 or 2
liters have been infused, cold Collins solution is infused
through the terminal aorta at the same time as the distal
thoracic aorta is cross-clamped and the cadaveric donor
is exsanguinated from a cannula previously placed in the
distal inferior vena cava. After removal, the cold liver is
flushed with Collins solution and protected by a plastic
bag which is placed in slushed ice. The performance of
kidneys removed from liver donors with this technique
was as good or better than has been achieved in most
centers with kidney removal alone (59). With minor
modifications, it has also been possible to remove the
heart in addition to kidneys and liver from seven donors.
During 1981 when 30 liver homografts were used, there
were 176 offers of organs. The inability to use the other
146 livers was usually because there was a disparity in
size between the donor and recipient, the donor blood
group was incompatible with the recipient, or Pittsburgh
facilities for liver recipient care were saturated. An actual
shortage of pediatric donors has existed in the 1- to 5-
year age group.
Recipient Hepatectomy
The most demanding aspect of liver transplantation is
removal of the diseased native organ. The technical
difficulties are usually determined by the underlying
disease. The easiest situations are in patients with pri-
mary hepatic malignancies or primary biliary cirrhosis.
The most difficult are in recipients with the shrunken
livers of macronodular cirrhosis or in patients with mul-
tiple previous operations. On the average, hepatectomy
is easier in infants and children than in adolescents and
adults.
The preexisting pathologic changes often necessitate
79
Vol. 2. No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
617
deviations from a standard plan; however, the first step
is to find the hilum and dearterialize the liver which
expedites hilar dissection and slows hemorrhage from the
liver surface. During hilar dissection, the bile duct is
transected as high as possible so that the option of duct-
to-duct anastomosis is retained. The portal vein is left
intact until later, in order not to aggravate the portal
hypertension.
The inferior vena cava below the liver is encircled with
minimal dissection. The left triangular and falciform
ligaments are incised until the suprahepatic vena cava is
identified. The suprahepatic vena cava is encircled to
allow placement of a cross-clamp.
If all of these maneuvers are successfully executed, the
liver can be isolated from the circulation by cross-clamp-
ing vessels which have been encircled but are intact.
Cuffs of the suprahepatic and infrahepatic vena cava are
fashioned from these vessels as the liver is removed.
Sufficient infrahepatic vena cava is not difficult to obtain,
but development of an adequate suprahepatic cuff may
require tailoring of the vena cava which is mobilized from
within the liver (46). The technique of isolating the liver
and peeling it out in a bloodless state permits all residual
tissue connections of the right triangular ligament and
the bare areas (including the right adrenal vein) to be
ligated under direct vision. The penalty with this ap-
proach is an increase (usually about 30 min) in the time
of portal and vena caval cross-clamping, compared to
cross-clamp time with previously described techniques
(1,32,43).
Such cross-clamping is usually tolerated in patients
with chronic disease in spite of major declines in cardiac
output and variable hypotension (60): the same thing has
been demonstrated in dogs subjected to chronic bile duct
obstruction (61). Because of this, venous bypasses which
were used in our first cases were discontinued (1, 2).
Some patients are jeopardized by the venous cross-
clamping. If severe hypotension occurs after cross-clamp-
ing, Calne et al. (52, 53) recommend femoral vein-to-
femoral artery bypass with an intervening oxygenator.
About 10% of the English patients are so treated. One
death in our last 67 patients (OT 233, Table 14), as well
as a cardiac arrest which was successfully treated, may
have been avoided by this precaution.
The fact that most patients recover from portal and
vena inferior caval cross-clamping may have created a
false impression about the safety of this practice. Usually,
there is gross swelling of the intestine during the period
of occlusion. Subsequently, many patients suffer from
third-space fluid sequestration and postoperative renal
failure. The extent to which these complex physiologic
events contribute to the high perioperative mortality has
not yet been delineated. For this reason, we returned in
recent cases (not reported in this communication) to the
practice of venous bypass which had been abandoned.
Cannulas are placed into the inferior vena cava through
an iliac or femoral vein and into the portal system
through the open end of the transected portal vein.
During the anhepatic phase, the blood is returned to a
reservoir and pumped to a large vein in the neck or arm.
Although this kind of bypass requires total body hepar-
inization, bleeding has not been excessive since the
"heparin effect" can be effectively reversed even in pa-
tients with severe liver disease.
Biliary Tract Reconstruction
Difficulties with biliary tract reconstruction were fre-
quently lethal in our experience (43, 62, 63) and in that
of the English workers (7, 49-51) until the mid-1970s.
Anatomic studies by Terblanche et al. (64) suggest that
deficient blood supply of the homograft duct system may
be a contributory factor; however, our principal problems
were due to the frequent (and inappropriate) use of
cholecystoduodenostomy and to failure to diagnose the
complications. The latter deficiency was resolved with
the frequent use of postoperative cholangiography (Fig-
ure 3) and reoperation, if necessary. The incidence of
complications has been reduced with better primary re-
construction.
We now consider duct-to-duct anastomosis to be the
procedure of choice (Figure 2A). When this is not feasible,
the duct is anastomosed to a Roux limb of jejunum
(Figure 2B). With either technique, the homograft gall-
bladder is removed The results of biliary tract recon-
struction in the last 67 cases are shown in Table 2. Using
choledochocholedochostomy or choledochojejunostomy,
an eventually satisfactory result was obtained in more
than 95% of cases, although the use of an internal stent
(instead of a T-tube stent) for duct-to-duct anastomoses
led to a high rate of reoperation. Only two deaths resulted
directly from biliary tract reconstruction.
Since 1976, Calne et al. (48) have used a technique in
which the homograft common duct and gallbladder are
fashioned into a common channel and anastomosed to
recipient common duct or a Roux limb. Waddell and
Grover (65) had described such a common channel pro-
cedure for difficult biliary tract problems.
The Question of Splenectomy
The spleen was removed in most of our early patients,
in part to achieve immunodepression, but mainly to
relieve hypersplenism and leukopenia which prevented
the effective use of azathioprine or cyclophosphamide
(32). With the advent of cyclosporin A, splenectomy was
discontinued.
Untreatable Complications
Technical complications that have occurred after liver
transplantation are legion. All have been potentially
treatable except for irreversible ischemic injury of the
graft or early loss of its blood supply. Retransplantation
is the only hope for a patient who has been given an
irreversibly damaged or devascularized organ. In one of
our patients, portal vein stenosis at the anastomosis was
diagnosed 8 months after transplantation, and, at reop-
eration, the stenosis was successfully resected in spite of
the fact that thrombosis had occurred requiring throm-
bectomy (Figure 4).
TISSUE MATCHING
The time constraints of liver preservation and urgent
recipient need usually preclude systematic efforts at tis-
80
618
STARZL ET AL.
Hepatology
Fig. 3. Biliary obstruction 8 months
after liver transplantation and a duct-to-
duct reconstruction in a 10-year-old
child. Note the ectasia of the recipient
common duct {arrow). At reoperation,
the graft common duct was anastomosed
to a Roux limb of jejunum with a good
result.
sue matching. With the random donor-recipient pairing,
good matches at the A, B, and DR loci have never been
obtained.
Hepatic transplantation has been performed (45, 50,
51, 66) against the recipient anti-donor T-warm anti-
bodies which cause hyperacute rejection of kidney hom-
ografts. To our knowledge, hyperacute rejection of the
liver has never been seen.
However, much more experience will be required be-
fore concluding that acceptance of "positive cross-
matches" against T-warm recipient antibodies is without
jeopardy. Data from the first 53 Pittsburgh cases is
summarized in Table 3. Patients for whom cross-matches
could not be performed or whose sera cross-matched
negative with recipient cells had better results than those
with cross-match positive donors. Although hyperacute
rejection was not observed in the latter recipients, the
postoperative courses were stormy. At least two of the
livers developed delayed massive necrosis.
From experimental studies, it is known that the liver
is resistant to hyperacute rejection. However, in animal
xenograft models in which the recipient has performed
heterospecific cytotoxins, humoral antibody rejection of
the liver is merely slower than that of the kidney; the
mechanisms of destruction are the same. The extent (if
any) to which the outlook after clinical liver transplan-
tation is depreciated by preformed antibodies is un-
known; many liver candidates have widely reacting T-
warm cytotoxic antibodies which reflect sensitization by
previous blood transfusions. For the time being, we con-
tinue to treat such highly sensitized patients.
If donor-recipient ABO blood group incompatibility
exists, renal grafts can be destroyed by isoagglutinins
(67). Liver grafts are resistant to this kind of hyperacute
81
Vol. 2, No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
619
Table 2. Primary Bile Duct Procedures and Complications in 75 Liver Transplantations on 67 Consecutive Patients
in the Cyclosporin Era
Choledochochole- Choledochochole- Choledochojejunos-
dochoslomy with dochostomy with tomv in Roux-en Y
T-tube internal stent with stent
Cholecvstojejunos-
tomy in Roux-en-Y
External tube
drainage
Biliary reconstruc-
tion not completed
(intraoperative
death)
No.
25
19
20
6
Success
20
11
18
1
(80%)
. iff . j
(90%)
f.17%)
Failure
5
8
2
5
Reoperation required
4'
7*
2
5
Cause of death
0
1
1
0
Nature of failure
Obstruction
1
3
0
4'
Bile leakage
4
4
2
1
Arterioductal fistula
0
1
0
0
" Reconstruction was never completed in 2 of the 3 patients.
6 One patient was treated with transhepatic dilation under X-ray control
One patient developed a large fungal liver abscess, which led to retransplantation. He is doing well with the second liver graft 1 year later.
Fig. 4. (a) Stenosis of the portal vein anastomosis yarrow) diagnosed by transhepatic portography in the same patient whose biliary system is
shown in Fig. 3. lb) Operative venogram obtained through a mesenteric vein a few days later. The obstruction was complete, and the homograft
portal vein was full of thrombus, (c) Patent system after resection of the sterosis, thrombectomy, and reanastomosis.
Table 3. Influence of Transplantation against Donor-
Specific Cytotoxic T-Warm Antibodies (Cyclosporin Era)"
Survival (months)
Table 4. Cases of Donor-Recipient Blood Group
Incompatibility in 53 Consecutive Primary Liver
Transplantations at the University of Pittsburgh
>1
>2
[m ompatibil-
F,.irl\ graft function
i ini. Dine
Negative cross-
match
Positive cross-
match
Cross-match not
done
31 24 22
177', i
8 5 5
(63%) (63%)
14 13 in
(9 ft i
21
(68%)
4
i.Mr, i
12
193
iy<s
A— B
A^ B
Good
Good
Well. 12 months
Died, systemic aspergil-
losis, 8 days
" Data from 53 consecutive primary transplants at the University ,,i
Pittsburgh.
rejection (45). In two of our Pittsburgh cases, two incom-
patible donors were used (Table 4). The course of one of
these patients is shown in Figure 6. We have tried to
avoid this practice since blood group compatible donors
can usually be found.
IMMUNOSUPPRESSION FOR HUMANS (THE
KIDNEY TRANSPLANT PROTOTYPE)
It was important to demonstrate in animals that
chronic survival is possible after liver transplantation
under immunosuppression. However, such laboratory in-
vestigations contributed relatively little to the immuno-
suppressive regimens which have been used clinically.
Liver transplantation, either in animals or man, was too
complex to be used as a model to evaluate drugs or drug
82
620
STARZL ET AL.
Hepatology
combinations. Instead, all methods to prevent or reverse
rejection of whole organs have depended upon observa-
tions after renal transplantation.
The immunosuppressive protocols that have been de-
veloped for human renal transplantation are summarized
in Table 5, exclusive of the historically important trials
with total body irradiation (68). Because the first genu-
inely promising drug, azathioprine (8), proved to be ef-
fective only rarely when given alone (69), the "modern"
era was not entered until it was realized that azathioprine
and prednisone have an additive (or possibly synergistic)
effect (67, 70-73). At the outset, our policy was to begin
therapy after renal transplantation with azathioprine and
to add high doses of prednisone with the first signs of
rejection (70). Because it was rare to escape rejection
even after transplantation from closely related donors,
our recommendation (67) was to begin treatment with
both drugs immediately after transplantation with a
gradual reduction in prednisone. Such "double-drug ther-
apy" has been the most commonly used immunosuppres-
sion for almost 20 years.
With transplantation from consanguineous donors un-
der double-drug treatment, chronic renal graft function
was achieved almost immediately in more than two-
thirds of cases. However, during the first year after
cadaveric renal transplantation, the graft loss rate in
multicenter compilations remains at about 50% (74, 75).
Liver recipients for whom cadaveric donors were obliga-
tory, and who did not have the option of fall-back main-
tenance on an artificial organ therapy analogous to renal
dialysis in the event of rejection, were confronted with a
bleak outlook.
Between 1963 and 1979, several alternative therapeutic
programs were introduced for renal transplantation
(Table 5); all were modifications of or additions to the
original double-drug therapy. A promising approach in-
volved lymphoid depletion with ALG (36) which was
given i.m. or i.v. as an adjunct to azathioprine and pred-
nisone during the first few weeks or months when the
risk of rejection is the greatest. "Triple-drug therapy"
has been the second most commonly used technique of
immunosuppression. A conceptually important but prag-
matically inconsequential detail was that cyclophospha-
mide could be freely substituted for azathioprine (76).
The results of 1-year graft survival after cadaveric renal
transplantation under triple-drug therapy were improved
in most centers. After the discontinuance of ALG, there
was an unacceptable rate of delayed rejection which, not
surprisingly, also occurred after liver transplantation
(32). The alternative of temporary lymphoid depletion
with thoracic duct drainage (TDD) (77) in preparation
of patients for cadaveric renal transplantation (78) had
the same disadvantage (79). Efforts to use preoperative
TDD in liver recipients usually, created insurmountable
problems because of the prodigious quantities (as much
as 2 liters per hr) of thoracic duct lymph which patients
with hepatic insufficiency produced (80). Lymphoid de-
pletion by total lymphoid irradiation for conditioning
before grafting (81, 82) has not been tried in liver recipi-
ents.
There was widespread discontent with all techniques
of immunosuppression from 1963 to 1978. Many kidney
transplant surgeons attempted to escape the conse-
quences of this therapeutic cul de sac by exploiting
developments in tissue typing and matching, or by sys-
tematically conditioning prospective renal recipients
with preoperative blood transfusions. The former efforts
yielded disappointing results after cadaveric kidney
transplantation; the latter practice of conditioning by
transfusion allowed an increased success rate in patients
not accidentally sensitized during their preparation. In
any event, liver transplantation candidates usually were
too ill to wait for a well-matched liver or to undergo
stages of preoperative preparation. For future trials of
liver transplantation, it was necessary to hope for better
immunosuppressive drugs. This did not seem realistic
until the advent of cyclosporin A.
Cyclosporin A is an extract from the fungi Cylindro-
carpon lucidum and Trichoderma polysporum. It was
discovered and characterized biochemically by scientists
at the Sandoz Corp., Basel, Switzerland. Cyclosporin A
was shown to be immunosuppressive by Borel et al. (83,
84) in mice, rats, and guinea pigs. The drug depressed
humoral and cellular immunity with a preferential and
quickly reversible action against T-lymphocytes. These
effects were not accompanied by bone marrow depression
which frequently limits the doses of azathioprine and
cyclophosphamide. The unusual effectiveness of cyclo-
sporin A in preventing or delaying rejection of mouse
skin homografts was demonstrated by Borel et al. (83,
Table 5. Clinical Immunosuppressive Drug Regimens Developed with Kidney Transplantation
Agents
Year described and re-
ported
Place
Deficiencies '
Used for liver
ransplantation
Azathioprine
1962 (69)
Boston
Ineffective, dangerous
No
Azathioprine — Steroids
1963 (70-73)
Denver. Boston, Richmond,
E din borough
Suboptimal
Yes
Thoracic duct drainage as
1963 (77)"
Stockholm
Nuisance; requires 20-30 days pre
Yes
adjunct
treatment
ALG as adjunct
1966 (36)
Denver
Still suboptimal
Yes
Cyclophosphamide substitute
1970 (76)
Denver
No advantage except for patients
Yes
for azathioprine
with azathioprine toxicity
Total lymphoid irradiation
1979 (81, 82)
Palo Alto, Minneapolis
Dangerous; extensive preparation;
not quickly reversible
No
Cyclosporin A alone
1978-1979 (90, 91)
Cambridge
Suboptimal
Yes'
Cyclosporin A — Steroids
1980 (92, 93)
Denver
Under evaluation
Yes -
' It was not realized until much later that pretreatment for 3 to 4 weeks before transplantation was a necessary condition (78).
83
Vol 2. No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
621
84). Analogous observations in which heart, kidney, liver,
and pancreatic grafts were protected in rats, rabbits,
dogs, and pigs were reported by Kostakis (85), Calne
(86-88), and Green (89) and their associates.
When cyclosporin A was first used in patients by Calne
and coworkers (90, 91), it was hoped that no other drug
would be routinely required. Our dissenting opinion is
that cyclosporin A should be combined with steroid
therapy from the outset (92, 93). The extent to which
steroids are required with cyclosporin A remains to be
clarified, but it is clear that kidney survival of greater
than 80% can be expected 1 year after primary cadaveric
transplantation (93, 94). Long-term follow-up of our orig-
inal recipients and those of Calne has not shown a
tendency for patients under cyclosporin A to have "catch-
up" graft losses or unexpected delayed morbidity from
other causes. We and Calne have not had the disillusion-
ment reported by Carpenter et al. (95) and Sweny et al.
(96) in their first trials with cyclosporin A for cadaveric
renal transplantation.
As new teams begin using cyclosporin A, it will be
important to avoid unrealistic expectations about early
convalescence that could be engendered by the high
success rates achieved after cadaveric renal transplanta-
tions. In a recent analysis of 42 consecutive cadaveric
renal recipients (97), only one-third had a completely
uneventful recovery. Of the remainder, most developed
rejection which was usually reversed with augmented
steroid therapy. In every case, the major differential
diagnosis was rejection vs. nephrotoxicity from cyclo-
sporin A.
Nephrotoxicity of cyclosporin A was first noted by
Calne (90, 91) and Powles (98), and has been confirmed
elsewhere (92, 99). To sharpen the interrelationship be-
tween therapeutic effect and toxicity, pharmacologic (cy-
closporin A blood and/or plasma levels) and immunologic
monitoring were advocated by Keown (100), Rynasiewicz
(101), and Kahan (102). Our techniques of management
have not depended upon these monitoring techniques.
Fortunately, nephrotoxicity usually has promptly re-
versed with reduction of cyclosporin A doses. As a last
resort, a change from cyclosporin A to azathioprine has
been made but at an increased risk of rejection (99).
Most other side effects of cyclosporin A (90-94) are not
serious and include gingival hyperplasia, tremor, regional
flushing or vague abdominal discomfort just after drug
ingestion, and development of brtast fibroadenomas in
women. Although hepatotoxicity occurs in about one-
fifth of cases (103), it is rarely serious enough to neces-
sitate a change to azathioprine.
The most publicized question about cyclosporin A
concerns its potential oncogenicity. It has been known
for 15 years that conventional immunosuppression re-
sults in an increased incidence of de novo tumors, of
which approximately one-third are lymphomas (104).
Early reports by Calne (91) of lymphoma development
in patients treated with cyclosporin A were not surpris-
ing, although the incidence of three lymphomas in 34
recipients was sobering. Calne attributed this high inci-
dence to the concomitant use of other cytotoxic drugs
and possibly steroids. In our own experience with cyclos-
porin A and steroid therapy in almost 200 cadaveric renal
recipients, there have been two lymphomas. One was an
incidental finding at autopsy following a fatal infection
(93). The other was successfully treated by intestinal
resection after it had caused a perforation (97). To our
knowledge, no de novo epithelial tumors have been seen
in renal recipients. As experience with cyclosporin A
accumulated worldwide, the spectre of this drug being a
spectacular tumor producer has receded. None of the
liver recipients treated with cyclosporin A and steroids
has developed new malignancies.
IMMUNOSUPPRESSION AND LIVER
TRANSPLANTATION
Two patients are known to have been given orthotopic
liver grafts without immunosuppression or with steroid
therapy only. The first patient was in the Cambridge
series (7); the other was treated in Oslo (21). One factor
in these decisions may have been the demonstration in
dogs (32, 33) and pigs (32, 40-42) that rejection of liver
grafts was less severe than that after renal transplanta-
tion. In addition, the English recipient had hepatitis
which it was feared would be reactivated by immuno-
suppression. Both organs promptly failed with early
death of the patients.
All other patients were given some variant of the
double- or triple-drug treatment summarized in Table 5
Our first five recipients and occasional ones later were
treated with azathioprine and prednisone. The same
treatment was used for almost all patients in the Cam-
bridge series from 1968 through 1979.
Triple-drug treatment was used in the majority of
recipients from 1966 through 1979. The most common
regimen was azathioprine, prednisone, and a variable
course of i.m. ALG which was begun on the day of
operation. The duration of ALG was usually limited to a
few weeks because of sensitization of the recipients to
horse, rabbit, or goat globulin; however, treatment with
ALG was continued in some cases for 6 to 12 months.
In a modification of triple-drug therapy (Table 5),
cyclophosphamide instead of azathioprine was given to
16 patients (OT 42-57) from March, 1971 to August, 1972
(105). Six (37.5%) recipients lived for at least 1 year, and
four (OT 42, 46, 53, 56) are still alive more than 10 years
later. From a few months to several years after trans-
plantation, all surviving patients were switched to aza-
thioprine. Because the results during this period were
not markedly different than with the original triple-drug
management, cyclophosphamide was not further used as
a first line drug.
In 1978 and 1979, TDD was used as an adjunct to
therapy with azathioprine and prednisone in 21 patients
(80). TDD was started 10 to 18 days before transplanta-
tion in 2 patients, on the day of operation in 17 patients,
and 2 and 4 weeks after transplantation in the other two.
Six (31.6%) of 19 recipients who had TDD started prior
to or on the day of transplantation lived for at least 1
year and five are alive after 3% to 4V5 years. The man-
agement dilemma was that in the kidney transplantation
model, TDD was ineffective unless applied at least 3
weeks in advance of transplantation (78), but potential
liver recipients could not tolerate the chronic, high-vol-
ume thoracic lymph drainage associated with hepatic
84
622
STARZL ET AL.
Hepatology
disease. If TDD is to be tried again in liver transplanta-
tion, a closed system will be required in which lympho-
cytes can be removed in transit without the necessity for
lymph removal and later reinfusion.
Calne et al. (91) were the first to use cyclosporin A for
liver transplantation. In their first two cases, cyclosporin
was used alone. However, most of their experience has
been with delayed administration of the drug (53, 106).
Azathioprine (1.5 mg per kg per day) and prednisolone
(0.4 mg per kg per day) were used until renal and hepatic
functions were adequate. Then, cyclosporin A (10 mg per
kg per day) was begun, and the steroid dose was slowly
reduced to zero. The supervention of acute rejection
during treatment with azathioprine and prednisone was
troublesome and, in the last review by Calne et al. (53),
they recommend shortening this period.
Our practice (107-109) has been to start cyclosporin A
a few hours preoperatively with an p.o. dose of 17.5 mg
per kg (Figures 5 to 7). Cyclosporin A is continued daily,
but with reduced i.m. or i.v. quantities (Figure 7) until
p.o. diet is resumed. Subsequently an p.o. dose of 17.5
mg per kg per day is given, usually with half the daily
dose every 12 hr. The quantities are reduced subse-
quently if toxic manifestations develop, of which neph-
rotoxicity has been the most important (Figures 5 and
6). Usually, steroids are also started on the day of oper-
ation. For adult patients who leave the operating room
in relatively good condition, a 5-day burst of prednisolone
is given, starting at 200 mg and stopping with a mainte-
nance dose of 20 mg per day (Figure 5). Further reduc-
tions of cyclosporin A and steroid doses are made on an
individualized basis. Initial and maintenance therapy
with steroids are reduced in infants and children (Fig-
ure 6).
If the patient was in poor postoperative condition, the
initial burst of high-dose steroid therapy was omitted for
a few days or greatly reduced (Figure 7). A few patients
suspected of having nephrotoxicity from cyclosporin A
were switched temporarily to azathioprine with resump-
tion of cyclosporin A treatment as renal function im-
proved (Figure 6). With less severe renal impairment
(Figures 5 and 7), the dose of cyclosporin A was reduced.
No patient has been changed to azathioprine perma-
nently. If rejection occun-ed in spite of this therapy, the
principal responses have been to administer intermit-
tently large i.v. doses of hydrocortisone (or prednisolone)
(Figures 5 and 7), repeat the original 5-day burst of
steroids (Figure 7), and settle at a higher maintenance
level of steroids. Although cyclosporin A does not permit
much dose maneuverability, it has sometimes been pos-
sible to increase the amounts given despite the risk of
nephrotoxicity.
REJECTION AND ITS MODIFICATION
To interpret much of the statistical information to be
presented later in this review, it will be necessary to
describe the features of homograft rejection as these have
been perceived by the pathologist and surgeon.
The Morphologic Events of Rejection
Despite treatment with any of the immunosuppressive
regimens so far used, rejection of human hepatic homo-
grafts has been observed. A clear picture can be pieced
together from studies of orthotopic liver transplantation
in rats, dogs, pigs, baboons, and humans of the sequence
of pathologic events which occur when a modified or
unmodified recipient rejects a liver graft (110-113).
In untreated members of all species (the principal
observations have been in dogs), there is a quiescent
phase of at least 2 or 3 days during which only rare small
lymphocytes are found in the tissue spaces of the liver
o _.
tn E
< E
>■ c*
" E
150
100
50
0
500
1000
47 YEAR OLD 9
44 kg
Hllllllllli
S S « I GRAM HYDROCORTISONE
i
FlC. 5. Double-drug immunosuppres-
sion with cyclosporin A and steroids. The
patient (OT 198) had a hepatoma, a-1-
antitrypsin deficiency, and chronic ac-
tive hepatitis. The reduction of the cy-
closporin A dosage after 4 days was be-
cause of the increasing azotemia. The
boluses of hydrocortisone were given be-
cause of a possibly unwarranted suspi-
cion of early rejection.
TIME IN DAYS
85
Vol. 2, No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
623
Fie. 6. Immunosuppression with cy-
closporin A and steroids (plus temporary
azathioprine) in a 10-year-old girl fOT
193). Note that the 5-day opening burst
of prednisone therapy was scaled down
because of her small size. The temporary
discontinuance of cyclosporin A and re-
placement with azathioprine between
postoperative Days 10 and 15 was be-
cause of probable cyclosporin nephrotox-
icity. The patient who was of B blood
type was given the liver of an A donor.
t-
2
0
UJ
Z
SO
<=S
1- ™
* E
o
100
UJ
Z
80
60
z E
2~ 40
IX
0- 20
0
tfao
OT 193
10 years old
26 kg
DISCHARGE
•""'■ -""V,
"//////A W ///,'// /77'7 // }'s
AZATHIOPRINE
5 1° '5 20 25 30 60 90 120 150
DAYS
PRE-OP 0
Tx
Time in Days
at J™GH«7wDeh'ati0n fr°m f t "dard Ster°id therapV in a patient (0T 2 19) whose Perioperative condition was frail. The 5-day buret of postoperative
sterols was begun several days postoperatively but had to be repeated when rejection supervened. Before operation the patient ha heiXrenal
syndrome and encephalopathy and he had been on a ventilator for more than 1 week. Because of defective clotting, efforts .-place cen.rafvenous
vesils Z:ZZ6tZZT" TUitded,hn —°Uedhem0rT hEge W"h '^ '0SS °f 2° *" °f bl00d ™< -bclavfin "nd innomi^n
«t^S Th M?? ,h/ou8h1cerv,cal a"d thoracotomy incisions, and the bleeding was mechanically controlled before transplantation was
Started The blood loss from placement of the vascular lines exceeded that incurred during transplanUtion. The patient sur^ved because ot
prompt corrects of the coagulation abnormalities. He is at home 5 months after transplantation
86
624
STARZL ET AL.
Hematology
which remain normal except for nonspecific changes.
However, during this period, large pyroninophilic cells
start proliferating in the paracortical zones of the host
lymph nodes. About 3 days after transplantation, lym-
phoid cells begin to leave portal vein tributaries randomly
throughout the graft. The venous endothelium is sepa-
rated from the basement membrane, and fibrin collects
in the subendothelial space. After passing through the
vessel wall, lymphocytes accumulate in the portal tracts.
Smaller numbers of lymphoid cells migrate through the
walls of the central vein and the endothelial lining of
sinusoids. These cells invade the space of Disse and some
enter between hepatocytes. Immunoglobulins are rare in
the cytoplasm of the infiltrating cells at this time.
Associated with cellular infiltration, the cells of many
sinusoids disintegrate, blood flow through the liver begins
to decrease, and some centrilobular cells die. As the
centrilobular necrosis progresses to midzonal necrosis,
liver function becomes affected. Inspissated bile appears
in surviving bile canaliculi and lipid droplets accumulate
in the hepatocytes around the portal tract. Shortly before
the death of the untreated recipient, foci of fibrinoid
necrosis sometimes occur in the walls of small branches
of the hepatic artery associated with deposition of im-
munoglobulin and complement in the intima and media.
When rejection is mild, as in pigs (115), or is modified
by immunosuppressive agents, as in dogs and humans
(110, 112-114, 116), destruction of hepatocytes ceases,
cellular infiltration diminishes and may disappear, but
the central part of the lobular reticulin framework often
collapses. Accumulation of bile in surviving centrilobular
hepatocytes and in bile canaliculi occurs; the cause of
this severe cholestasis is not known and may be second-
ary to widespread loss or distortion of canalicular micro-
villi. An alternative possibility has been put forward by
My burgh et al. (Ill) who drew attention to the progres-
sive hypertrophy and dilatation of smooth endoplasmic
reticulum in the centrilobular hepatocytes and suggested
that these intracellular changes might be caused by hu-
moral antibody and result in disrupted cholesterol and
bile salt metabolism with production of excess lithocho-
late. In some patients, the larger interlobular bile ducts
disappear as modified rejection continues. This phenom-
enon is characterized by rapid and relentless rise in serum
bilirubin (49-51, 116).
As rejection progresses, connecting bands of reticulin
are often laid down between the central areas, subdivid-
ing the lobules. What triggers progression to hepatic
fibrosis in some grafts is unknown; excess lithocholate
has been implicated (111). In some patients, cirrhosis is
produced. Another characteristic feature of chronic re-
jection is progressive thickening of the intima of the
branches of the hepatic artery in the homograft. The
intima contains fat-laden smooth muscle cells and mac-
rophages, and the lumen is narrowed or occluded. These
arterial changes occur in many long-surviving liver hom-
ografts. The accumulation of immunoglobulins and com-
plement in the altered vessel wall has raised the possi-
bility that this damage is a late manifestation of rejection
brought about by circulating antibody. Deposition of
immunoglobulins is less striking in hepatic grafts than in
transplant kidneys (117), prompting speculation that he-
patic rejection was more a phenomenon of cell-mediated
immunity (as opposed to damage by circulating anti-
bodies) than has been thought to be the case with reject-
ing kidney grafts.
Some histopathologic changes in liver homografts may
be caused by hepatotoxic drugs, viral hepatitis, or other
factors. However, a comparison of changes in human
specimens with those in animal homografts emphasizes
that the major alterations are immunologic in etiology.
The Clinical Manifestations of Acute
Rejection
Rejection as defined by us (32) and Williams and Calne
(7) in patients treated with conventional immuno-
suppression also occurs during treatment with cyclos-
porin A and steroids. Many patients lose their appetites
and become depressed. Fever, vague upper abdominal
pain, and ascites are variable. By palpation, grafts are
frequently swollen, hard, and mildly tender. Radioiso-
topes used for liver scanning are poorly concentrated,
whether these depend upon parenchymal or reticuloen-
dothelial function. Elevations may occur in serum bili-
rubin, alkaline phosphatase, and transaminases. Failure
of synthetic function is most readily detected by meas-
urements of prothrombin time.
The various manifestations of rejection occur in differ-
ent combinations, to variable degrees, and at unpredict-
able times. The resulting patterns have been categorized
as "anicteric," "indolent," and "crisis" (32). With a rejec-
tion crisis, jaundice can develop with astonishing rapid-
ity, usually just after or accompanied by major rises in
transaminases. The insidious indolent rejections have
been the most difficult to reverse.
All patterns of graft deterioration are nonspecific.
Proven alternative etiologies include ischemic injury,
biliary obstruction, cholangitis, hepatitis (B virus, cyto-
megalovirus, adenovirus, herpes), and drug toxicity. Con-
sequently, diagnostic procedures, often including chol-
angiography and needle biopsy, must be considered if the
postoperative evolution is not satisfactory. In the interim,
steroid dosage is temporarily increased and returned to
baseline if a diagnosis other than rejection is established.
Clinical management is particularly difficult and fraught
with error if good initial graft function was not achieved.
A devastating complication of rejection, termed "septic
hepatic gangrene," occurred in patients who were treated
with azathioprine, ALG, and relatively low doses of pred-
nisone. After days or weeks of slightly abnormal hepatic
function, these patients developed massive hepatic ne-
crosis with extremely elevated serum transaminase activ-
ities and deterioration of other measures of hepatic func-
tion. Raging fevers, bacteremia, and disappearance on
liver scans of large portions of hepatic parenchyma sig-
naled regional infarctions within the transplants. Kinking
of lobar or segmental hepatic arteries was originally
postulated to be responsible for this complication (5), but
the most important factor is poorly controlled rejection
(32). With diminution in total hepatic blood flow, as was
documented in canine experiments by Groth et al. (31),
invasion of the ischemic homograft by microorganisms
from the adjacent intestinal tract is not surprising.
Study of patients with septic hepatic gangrene and
confirmatory observations by Brettschneider et al. (118)
after canine and porcine liver transplantations clarified
87
Vol. 2, No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
625
the interaction between rejection and homograft bacte-
rial colonization. In animal studies, the normally low
incidence of positive cultures from liver tissue of dogs
and pigs increased after sham operations. When an he-
patic ischemic injury was added by performance of sim-
ulated autotransplantation, all livers became contami-
nated, primarily with the same organisms concomitantly
present in the upper intestine. Bacteria] counts were
somewhat lower if the common bile duct was left intact
than when the duct was ligated and bile drainage restored
by cholecystoenterostomy. The bacterial changes were
more pronounced in liver homografts transplanted to
unmodified or immunosuppressed animal recipients.
Presumably, any ischemic or necrotic area can become
a septic focus, particularly if the host is given immuno-
suppressive therapy and cannot respond normally to
invading microorganisms. The spectrum of resulting in-
fections under conventional immunosuppression has
been well studied (32, 119-121). Paradoxically, one of the
most important ways to prevent nontreatable liver infec-
tion is to protect the graft with potent immunosuppres-
sion, especially during the early postoperative period.
The second obvious step is to provide systematically
designed antibiotic therapy intraoperatively and for sev-
eral days thereafter.
Acute cellular rejection in grafts sampled by biopsy or
at autopsy has been encountered many months or years
after transplantation. Some patients were known to have
discontinued their medications but others had been given
unwise advice about lowering maintenance medications.
Increased steroid therapy was given under such circum-
stances.
Chronic Rejection
The diagnosis of chronic rejection was restricted to
patients whose grafts had arterial intimal thickening,
hepatic fibrosis, and other findings described previously.
These findings are not necessarily time-related since they
often develop within the first few months. Clinical man-
ifestations of chronic rejection were not much different
from those of chronic liver failure from endstage disease
of differing etiologies. Treatment with increased immu-
nosuppression was ineffective.
SURVIVAL AFTER TRANSPLANTATION
The introduction of cyclosporin A and steroids has had
such a major influence upon results that patients have
been divided into those treated before and after this
event. By so doing, it is possible to reexamine several
factors whose significance was previously unclear.
Precyclosporin Era (1963 to 1979)
Between 1963 and the end of 1979, 170 patients had
liver replacement. In previous publications, the identifi-
cation of individual recipients by orthotopic transplan-
tation (OT) numbers made it possible for the interested
reader to follow their progress from report to report. The
same code numbers will be used throughout this review.
In past reports (45, 80, 107), the first 170 recipients
were divided into the three successive series summarized
in Table 6 and Figure 8. In the first, second, and third of
these consecutive groups, 1-year survival was 28.8, 50
and 34.5%.
Of the 56 recipients who survived the first postopera-
tive year, 23 died at the times shown in Table 6. Although
13 of 23 late deaths were in the second postoperative
year, deaths occurred as late as 6 years. Of the original
170 patients, 33 (19.4%) are alive after follow-ups of 2V6
to 12'/2 years. Twenty have survived for more than 5
years and four are into the second postoperative decade.
There was an almost equal division in the total period
of 1963 to 1979 between adult (>19 years) and pediatric
(<18 years) recipients. From the sixth month onward,
the younger patients had about a 10% survival advantage
(Figure 9).
N - 111 [1963-1976)
N = 30 (1976-1978)
N = 29 (1978-1979)
18 24 36 48 60
MONTHS
Fig. 8. Survival of three consecutive series of patients treated with
orthotopic Itver transplantation under conventional immunosuppres-
sion. The dashed lines in Series 2 and 3 are actuarial projections.
48
60
24 36
MONTHS
Fie. 9. The life survival of adults vs. children in patients treated with
conventional immunosuppression.
Table 6. Late Deaths in 170 Patients During Precyclosporin A Era (1963-1979)
No
Alive after
1 year
Died after
1 year
Time of late death to
nearest postop month
Alive
now
Years follow-up
of survivors
Series 1
Series 2
Series 3
111
30
29
31 (28.8%)
15 (50%)
10 (34.5%)
18
4
1
12, 13, 13, 13, 14, 16, 17, 20, 20, 21
25, 26, 28, 30. 36, 41, 54, 72
17, 23, 49. 56
13
13
11
9
614-1254
4H-5'A
2V4-4W
88
626
STARZL ET AL.
Hepatology
Table 7 summarizes the results in the Cambridge-
King's College trials from 1968 through early 1980 (53,
122). In this series, 22 (23.7%) of the first 93 recipients
lived for at least 1 year, with 11 subsequent deaths during
the second to sixth years; the 11 survivors had been
followed for 1 to 6 years. The better 1-year survival in
the American compared to the English trial (33 vs. 24%)
was partly illusory since Calne and Williams accepted for
surgery few pediatric patients with whom (Figure 9) our
best results were obtained in those years.
Our results in the pediatric age group after transplan-
tation for different indications are given in Table 8.
Similar information for adult recipients is provided in
Table 9.
Cyclosporin Era (1980 to 1982)
The longest follow-ups for our patients treated with
cyclosporin A and steroids are only 2'/fi years. During the
Table 7. Actual 1-Year Survival" in Cambridge/King's
College Series of 93 Cases (1968 to February, 1980)
93
77 (82.8%)
31 (33.3%)
22 (23.7%)
" Information from (122). Of the 22 one-year survivors. 11 had subsequently
died from 1 to more than 5 years postoperatively The other 11 were living in
their second to sixth postoperative year An actuarial projection of this data
beyond 1 year is depicted in Figure 10.
Table 8. Indications for Transplantation and Survival in
Pediatric Patients (S18 Years) from 1963 Through 1979
(Precyclosporin A)
Survival (months)
>1
>2
>6
>12
Now"
Biliarv atresia
51
37
27
16
14
7
(73%)
(53%)
(31%)
(27%)
(14%)
Inborn meta-
13s
12
11
8
8
6
bolic errors
(92%)
(85%)
(62%)
(62%)
(46%)
Chronic aggres-
13
11
10
7
5
3
sive hepatitis
(85%)
(77%)
(54%)
(38%)
(23%)
Hepatoma
3'
3
3
2
2
0
Neonatal hepa-
2
1
1
1
1
0
titis
Congenital he-
2
1
1
1
1
1
patic fibrosis
Secondary bili-
•yi
2
2
2
2
1
ary cirrhosis
86
67
55
37
33
18
(78%)
(64%)
(43%)
(38%)
(21%)
1 Follow-ups for living patients are 2W to 12'/i years.
b Inborn errors
a-1-antitrypsin deficiency
Wilson's disease
Tyrosinemia
Type IV glycogen storage disease
9
2
1
1
13
' Five other patients had incidental malignancies (4 hepatomas and
1 hepatoblastoma) in their excised livers. The principal diagnoses in
these five cases were biliary atresia (3 examples), a-1-antitrypsin defi-
ciency (1 example), and congenital tyrosinemia (1 example). The diag-
nosis of the neoplastic change was known in advance only in 2 of the 5
cases.
d Secondary to trauma or choledochal cyst (one each).
Table 9. Indications for Transplantation and Survival in
Adult Patients (>19 Years) from 1963 Through 1979
(Precyclosporin A)
Survival (months)
>1
>2
>6
>12
Now"
Chronic aggres-
33
21
17
14
11
7
sive hepatitis
(64%)
(52%)
(42%)
(33%)
(21%)
Alcoholic cir-
15
8
5
4
4
3
rhosis
(53%)
(33%)
(27%)
(27%)
120%)
Primary malig-
15'
9
7
4
3
1
nancy
(60%)
(47%)
(27%-)
(20%)
(7%)
Sclerosing cho-
7
7
4
2
2
0
langitis
Primary biliary
6
3
3
2
1
1
cirrhosis
a- 1 -antitrypsin
2
1
1
0
0
0
deficiency
Secondary bili-
2'
1
1
1
1
1
ary cirrhosis
Hemochromato-
1
1
0
0
0
0
sis
Protoporphyria
1
0
0
0
0
0
Budd-Chtan
1
1
1
1
1
1
syndrome
Acute hepatitis
1
1
1
0
0
0
B
84
53
40
28
23
14
(63%)
(48%)
(33%)
(27%)
(17%)
" Follow-ups for living patients are 7}A to 8]/i years.
b Seven hepatomas, 5 duct cell carcinomas (Klatskin), 1 cholangio-
carcinoma, 1 hemangioendothelialsarcoma, and 1 unclassified sarcoma.
' One example each of possible duct hypoplasia and choledochal
cyst; both patients had had multiple operations.
first 9 months of 1980, 14 patients entered into this trial
at the University of Colorado (108); 2 died during the
operation, and 1 died after 19 days. The other 11 patients
survived for more than 1 year. Eight are alive after 21 to
28 months. The 1-year survival of 78.6% could have
represented a sampling accident. However, at the Uni-
versity Health Center of Pittsburgh, 26 patients were
treated in 1981. Five died in the first postoperative
month, and additional deaths occurred in the second,
third, and fourth months. With follow-ups of 6 months to
more than 1 year, the remaining 18 (69.2%) recipients are
alive and at home; none has poor hepatic function.
The pattern of predominantly early mortality seen in
1980 and 1981 has continued into 1982. Of the first 27
recipients treated in 1982, 8 died. Six, one, and one of
these deaths were in the first, second, and third postop-
erative months, respectively.
It is too early to assess the rate at which late deaths
will occur, since only 18 patients treated with cyclosporin
A have reached or passed the 1-year mark. Of these,
three died in their thirteenth, sixteenth, and twentieth
postoperative months for reasons that will be considered
in the next section.
The actuarial survival calculated from the cases in the
cyclosporin era studied to date is shown in Figure 10. In
comparison to our previous experience in the precyclo-
sporin era and in comparison to the Cambridge-King's
College compilation, survival has more than doubled.
89
Vol. 2, No. 5. 1982
EVOLUTION OF LIVER TRANSPLANTATION
627
80-
|l Cyclosporin A « x N = 67 (1980-1982)
\ Azathioprine • • N = 170 11963-1979}
^ Cambridge o o N = 93 11968-1980 Feb )
50
\v "\^
40-
20-
n-
~~ — -o
0 6 12 16 24 30
MONTHS
Flo. 10. The actuarial survival of patients treated with cyclosporin
A and low-dose steroids compared to the actual 1-year survival obtained
under conventional immunosuppression by us (azathioprine) and the
workers at Cambridge The data for the Cambridge curve were obtained
from published reports (53, 122).
The results calculated for the first 12 postoperative
months have not been different in adults and children
(Figure 11). A breakdown of results according to original
disease in the pediatric and adult cases is provided in
Tables 10 and 11.
The influence of cyclosporin A upon survival in the
Cambridge-King's College trials has not been clearly
defined, because the drug has not been regularly used
and because it was started late in most cases after an
initial course of azathioprine and steroids. Nevertheless,
improved results have been attributed by Calne et al.
(53) to better immunosuppression.
CAUSES OF MORTALITY
Precyclosporin Era
Early Death. The appalling early mortality after liver
transplantation has prompted exhaustive clinical-patho-
logic analyses of our failed cases. Using the OT code
numbers of the patients, the results have been reported
in such a way that individual assessment of almost every
early death in the first 170 cases can be made by the
interested reader (43, 45, 80). Mortality figures included
the use of grafts damaged by ischemia, massive operative
hemorrhage, thrombosis of the reconstituted homograft
blood supply, intraoperative cerebral air embolism (44),
unsuspected recipient abnormalities (such as prior
thrombosis of the portal vein), hopeless anatomical sit-
uations created by multiple previous operations, irre-
versible preexisting debilitation, and (above all) defective
biliary tract reconstruction.
With or without such factors, overwhelming infection
was frequently a terminal event. At autopsy, histopath-
ologic findings of acute rejection were found in 10 to 15%
of cases, prompting speculation that over immuno-
suppression, especially with prednisone, may have been
responsible for unnecessary deaths (43).
When serial biopsies were obtained in later cases (45,
80), this simplistic view had to be revised. Many biopsies
contained unmistakable findings of rejection for which
the appropriate response had been more steroids. After
death caused by infection, the findings of rejection were
absent. The conclusion was reached that even after a
perfect operation, the unacceptable acute mortality
would remain until improved immunosuppression be-
80
5 60
c/i
O
(X
20
Cyclosporin A
Children » — ~« N = 26
Adulls O— — o N = 41
0 3 6 9 12
MONTHS
Fig. 1 1 . The 1 -year actuarial survival of adults vs. children after liver
transplantation under immunosuppression with cyclosporin A and ste-
roids.
Table 10. Indications for Transplantation in Pediatric
Patients (<18 Years) from Mid- 1980 to May, 1982
(Cyclosporin Era). Follow-Ups for Survivors Are 1-21
Months
No.
Living
Biliary atresia"
11
8
Q-1-antitrypsin deficiency''
4
2
Chronic aggressive hepatitis
2
2
Bvler's disease'
2
1
St idarv biliarv cirrhosis1*
1
0
Budd-Chiari svndrome
1
0
Neonatal hepatitis
1
1
Subacute Wilson's disease*
1
1
Tyrosinemia''
1
1
Type I glycogen storage disease''
1
1
Sea-blue histiocyte syndrome''
1
1
26
18
am i
' Two had Alagille's syndrome.
h Inborn errors of metabolism. The children with tyrosinemia and
sea-blue histiocyte syndrome had incidental hepatomas in their cir-
rhotic livers.
Diagnosis equivocal in one case.
'' Choledochal cyst with multiple operations.
Table 11. Indications for Transplantation in Adult Patients
(>19 Years) from March 1. 1980 to May I. 1982 (Cyclosporin
Era). Follow-Up for Survivors Was 1-27 Months
No.
Living
Chronic aggressive hepatitis
Malignancy"
Primary biliary cirrhosis
Secondary biliary cirrhosis
2 trauma
1 Caroli
1 choledochal cyst
Sclerosing cholangitis
a-1-antitrypsin deficiency
Budd Chiari syndrome
Adenomatosis"
3
2
2
1
2
1
1
1
1
28
(68%)
"One patient in each group had previous (1 and A\'i years earlier)
right hepatic trisegmentectomy. At transplantation, the regenerated
left-lateral segment was replaced with a whole liver.
90
628
STARZL ET AL.
Hepatology
came available. Both nonimmunologic and immunologic
complications have continued to cause early deaths in
the cyclosporin era albeit at a reduced rate.
Deaths After 1 Year. Assessment of the reasons for
late death in older cases may help to predict the spectrum
of problems which can be expected in future patients.
The causes of mortality after 1 year in patients treated
with conventional immunosuppression are listed in Table
12. Recurrent liver failure was responsible for death in %
of 23 patients, if the four who died after attempted
retransplantation are included. In three patients, the
main mortality factor was recurrence of malignancy. One
of the late deaths was caused by chicken pox hepatitis
during an epidemic on the transplantation ward. The
patient (OT 112) whose death was classified under self-
abuse was an alcoholic, drug abuser, and derelict who
resumed the same life style after transplantation. Fifty-
six months after transplantation, he was found uncon-
scious in a ditch in Florida and died of pneumonitis.
The dominant pathologic diagnoses of the 24 first or
second grafts which functioned chronically in these 23
patients are listed in Table 13. Chronic rejection was the
Table 12. Causes of 23 Deaths" After 1 Year of Patients
Treated with Azathioprine (or Cyclophosphamide),
Prednisone, and ALG
Cause of Heath
No.
Predominant liver failure
Liver failure plus sepsis
Early after retransplantation
Recurrent cancer
Predominant sepsis
Self-abuse
Total
8
5
4*
3
2
1
23
" Deaths were usually caused by multiple problems, but only the
single most important factors are listed.
h Infection invariably contributed to death after retransplantation.
In addition, two patients had lethal technical complications and two
more had rejection.
Table 13. Principal Pathologic Changes in 24 Liver Grafts
that Had Functioned Under Conventional
Immunosuppression for 339 to 2,190 Days Before the Death
of the Patient." In 5 of the 24 Grafts, Two Diagnoses Were
Given
Pathologic changes
No.
Chronic rejection
Biliary obstruction
Recurrent cancer
Chronic hepatitis
Portal vein thrombosis
Chronic cholangitis
Chicken pox, hepatitis with necrosis
Early alcoholic hepatitis
Diffuse fatty changes with centrilobular necrosis
Total
11
6
4
2
2
1
1
1
1
29
" These 24 grafts were from the 23 patients who died after 1 year
(Table 12). Seven of the 23 patients were given two livers, but chronic
function (682 plus 403 days) was obtained from both organs in only one
case (OT 103); in the other six, the pathologic changes are tabulated
only for the long-surviving grafts. Most of the specimens were obtained
at autopsy, but a few were from surgical or closed biopsies.
most common final diagnosis, followed by biliary obstruc-
tion and recurrent cancer. There were two examples each
of chronic hepatitis and portal vein thrombosis.
These findings differ from those reported by Calne et
al. (53) in 11 patients who died after 1 year; recurrent
carcinoma was the main homograft abnormality in five
patients. In the other six grafts, there was biliary sludge
and cholangitis. Chronic rejection was not mentioned.
Our findings suggest that ongoing problems with immu-
nologic control will continue to take a gradual toll long
after successful transplantation, whereas interpretation
of the pathologic findings in the English recipients is
different. Clarification of this divergence of observations
will be important.
Cyclosporin Era
Twenty-two of the 67 patients treated in 1980 to 1982
died. Three deaths were after 1 year, and the other 19
were early.
Early Death. Fourteen of 19 early deaths, including
two on the operating table, occurred in the first postop-
erative month. In the second, third, and fourth postop-
erative months, there were 1, 1, and 2 more death(s),
respectively (Table 14).
Eight deaths were directly attributable to preexisting
anatomic conditions including multiple previous opera-
tions (OT 178), earlier portacaval shunt (OT 180), and
right-to-left pulmonary shunts secondary to the liver
disease (systemic arterial pO_. was 30 mm Hg) which did
not subsequently close (OT 203). However, the most
important abnormalities were in liver blood supply or the
vena cava (OT 217, 220, 228, 232, 233) which had not
been diagnosed preoperatively. At operation, it was not
possible to vascularize adequately homografts in 4 of
these latter 5 recipients. In the fourth (OT 233), the
superior vena cava was discovered at autopsy to have
been replaced by two innominate veins which descended
into the abdomen and emptied into the inferior vena
cava below the renal veins. During the vena caval cross-
clamping of the anhepatic phase of transplantation, the
child developed an acute superior vena caval syndrome
with irreversible brain injury.
Eight early deaths were technical and thus avoidable,
including the use of inadequately preserved grafts (OT
185 to 188), hepatic artery thrombosis (OT 183, 225), and
complications of biliary tract reconstruction (OT 201,
208). Problems in preservation were encountered in the
first four cases at a new institution.
Deaths After 1 Year. Patients died late (Table 14) of
recurrent Budd-Chiari syndrome (OT 174), recurrent
duct cell carcinoma (OT 176), and after retransplantation
after a primary graft was chronically rejected (OT 181).
THE POSSIBILITY OF RETRANSPLANTATION
In assessing ways of reducing patient mortality, it was
obvious almost from the beginning that aggressive at-
tempts at retransplantation offered the only chance of
survival for many patients whose first grafts failed either
early or late. Such efforts, which have been made in 27
patients (2 of the 27 also were given third grafts) since
1968 (Figure 1), usually have born bitter fruit. The few
successes that have been achieved have served as an
important stimulus for further trials.
91
Vol. 2, No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
629
Table 14. Major Causes of 22 Deaths in Cyclosporin Era
Age
Pathology before transplant
Major causes of death
Postoperative
month of
death
176
33
F
178
37
M
180
40
M
181
16
F
183
8
F
185
56
M
186
17
F
187
37
F
188
46
M
196
36
F
201
4
M
208 42
216
2
F
217
44
M
220
8
F
225
44
M
228
Budd-Chiari syndrome, portacaval shunt
Sclerosing cholangitis, duct cell carcmoma
Secondary biliary cirrhosis, gunshot wound
to liver
Sclerosing cholangitis, portacaval shunt
Budd-Chiari syndrome
Byler's disease
Klatskin's tumor
Secondary biliary cirrhosis, Caroli's disease
Chronic aggressive hepatitis, portacaval
shunt
Chronic aggressive hepatitis
Chronic aggressive hepatitis
a- 1 -antitrypsin deficiency disease
a-1-antitrypsin deficiency disease, exten-
sive pulmonary A-V shunt
Chronic aggressive hepatitis, o-l -antitryp-
sin deficiency disease, primary biliary
cirrhosis
Primary biliary cirrhosis
Biliary atresia, Kasai operation
Chronic aggressive hepatitis, splenectomy.
portal vein hypoplasia"
Secondary biliary cirrhosis, choledochal
cyst, portal vein thrombosis"
Q-1-antitrypsin deficiency disease
Alagille's syndrome, absent hepatic ar-
tery", hypoplastic portal vein"
Biliary atresia, Kasai operation, absent in-
ferior vena cava", malrotation"
Biliary atresia, Kasai operation, absent su-
perior vena cava with innominate drain-
age into inferior vena cava"
Recurrent Budd-Chian syndrome, liver
failure, sepsis
Recurrent duct cell cancer
Operative
Operative
1st graft: chronic rejection
2nd graft: acute rejection
3rd graft: liver failure, renal failure
Hepatic artery thrombosis
Graft necrosis, sepsis
Graft necrosis, sepsis, bile leakage
Graft necrosis
Graft necrosis, sepsis
Systemic aspergillosis
Hemorrhage during exploration of intra-
hepatic abscess and mycotic aneurysm
1st graft graft hypoxia due to pulmonary
A-V shunt
2nd graft: graft hypoxia; rejection
3rd graft graft hypoxia; cerebral hemor-
rhage
Hemorrhage from hepatic artery, bile duct
fistula
Rejection; sepsis due to duodenal stump
leakage after total gastrectomy for stress
ulcer hemorrhage
Chronic rejection, liver failure, sepsis
Operative
1st graft graft necrosis
2nd graft: cerebral hemorrhage
1st graft: rejection, hepatic artery throm-
bosis
2nd graft: rejection, sepsis
G.aft necrosis
Diffuse clotting in graft
Perioperative brain death
13
1
1
20
" Anomalies or abnormalities not known before operation.
The attempts at retransplantation in 27 patients are
summarized in Table 15. Eighteen of 27 second trans-
plantations were within the first 3 months, 3 were be-
tween 3 and 12 months, and 6 were after 12'/2 to 29
months.
Extended subsequent survival occasionally was
achieved with early and later retransplantation. The fate
of six patients whose lives were significantly prolonged is
summarized in Table 16. Much of life for the first four
recipients was a nightmare of morbidity because of the
combination of high steroid needs and slowly failing graft
function. However, the two patients who had successful
retransplantation in the cyclosporin A era, 1 and 3 weeks
after primary grafting, have had perfect results and are
at home 6 and 12 months later on daily prednisone doses
of 5 and 15 mg per day, respectively. In the first patient,
the primary graft had developed a huge fungus abscess;
in the second patient, the first graft had been rejected.
The performance of retransplantation has sometimes
been surprisingly easy. The procedure has been greatly
simplified by retaining cuffs from the suprahepatic and
intrahepatic vena cava and from the portal vein of the
first graft. Usually, it has been necessary to perform the
arterial anastomosis proximal to the previous site.
THE INFLUENCE OF ORIGINAL DISEASE UPON
RESULTS
Evaluation of the influence on survival of preexisting
hepatic disease is complicated by the fact that many
patients have more than one diagnosis (Table 17). Ten
(14.9%) of our last 67 patients had two coexisting hepatic
92
630
STARZL ET AL.
Hepatology
Table 15. Attempt at Retransplantation in 27 Patients" '
Months between first
and second transplanta-
tion
Months survival after sec*
ond transplantation
Conventional 21 <1 x 9 patients, <1 x 11 patients, 1, 1,
immuno- VA, 2, 2\ 3, 3'A, 5'/4, lfc, l1*, V/*, 2, 6, 12,
suppression 6, 12':, 16'?, 22'/2, 27, 13, 16
29
Cyclosporin— 6 <1 X 5 patients, 19 <1 x 3 patients, 3&,
Steroids 6r, 12'
" Two of the 27 had third transplantations, 1 and 7V4 weeks after
second transplantation had failed.
h One patient had a chimpanzee heterograft on the second occasion.
1 Alive.
Table 16. Time of Retransplantation in Six Patients Who
Subsequently Lived for >6 Months
Duration of first graft
Survival in months after second
graft
16
2 months
11
98
5W weeks
16
103
22V2 months
13
156
2 weeks
6
191
3 weeks
12'
209
1 week
6'
" In cyclosporin series, both alive.
Table 17. Patients in Cyclosporin A Series (67 Cases) with
Multiple Diagnoses
OTNo
Main diagnosis
Other diagnosis
176
Cholangiocarcinoma
Sclerosing cholangitis
188
Chronic aggressive hepa-
Heterozygous o-l-anti-
titis
trypsin disease
198
Hepatoma
a-1-antitrypsin disease,
chronic aggressive
hepatitis
206
Tyrosinemia
Hepatoma, diagnosed at
previous operation
208
Chronic aggressive hepa-
titis
a- 1 -antitrypsin disease
218
Type I glycogen storage
Multiple hepatic adeno-
disease
mas
222
Sea-blue histiocyte syn-
Hepatoma, diagnosed at
drome
previous operation
225
a- 1 -antitrypsin disease
(Pi ZZ)
Hemachromatosis
227
Hepatoma
Chronic aggressive hepa-
titis
234
Hepatoma
Chronic aggressive hepa-
titis
diseases; however, in most of our analyses (Table 8 to
11), only the most important diagnosis was tabulated.
No disease for which transplantation has been used
can be categorically excluded for further trials. This can
be appreciated by examination of results with different
kinds of disease in pediatric and adult patients before
and after the introduction of cyclosporin A (Tables 8 to
11).
Nevertheless, special problems can be expected in
treating some hepatic diseases. In the past, some patients
with biliary atresia died because of unexpected anomalies
which jeopardized performance of a technically satisfac-
tory transplantation (32); specific examples are listed in
Table 14.
Noncompliance may be a problem in patients treated
for Laennec's cirrhosis. Of our first nine patients with
alcoholic cirrhosis, eight died too soon to evaluate this
potential problem (123). There were several subsequent
successes (Table 9); only one recipient returned to toxic
drinking.
The Special Problem of Hepatic Malignancy
The possibility that immunosuppression may acceler-
ate metastatic tumor growth has been recognized (32).
Evaluations of transplantation in treating hepatic malig-
nancies were made in 1981 by Iwatsuki et al. (124) and
by Calne (122). Although recurrent disease exceeded 50%
in both series, the results did not allow definitive rec-
ommendations about continuation of these efforts.
Our case material has been divided into three groups.
In the first category were three children whose livers
contained malignant tumors (2 hepatocellular cancers, 1
hepatoblastoma) that had not been suspected preopera-
tively (Table 18). The two recipients who survived op-
eration have no evidence of recurrence after 4Vt to 12'/2
years. These observations suggest that malignancies can
be cured by liver replacement.
In the second category were eight patients, all treated
early in our experience, who died less than 1 month after
liver replacement for hepatic or duct cell cancer (Table
19). From this case collection, it was possible to deter-
mine by autopsy studies the frequency with which extra-
hepatic tumor spread had been missed in preoperative
evaluation. Only 1 of the 8 recipients had metastases.
Twenty-two additional patients, including one (OT
176) whose neoplastic lesion was missed at the initial
pathologic examination, lived long enough to evaluate
the influence of transplantation upon the malignancy
(Table 20). The first 12 were treated in the precyclosporin
era; nine recipients developed metastases. A tenth pa-
tient with an unclassified sarcoma had extrahepatic me-
tastases at transplantation, and she is well 5V> years later
with no clinical evidence of advancing disease. Five pa-
tients survived for longer than 1 year; even for those who
eventually died of metastases, the extension of useful life
seemed to be worthwhile.
Ten more patients have been treated in the cyclosporin
era (Table 20). Three had duct cell carcinomas (one with
sclerosing cholangitis); one of whom (OT 185) died early
without evidence of residual cancer. The second patient
(OT 176) died of metastatic cholangiocarcinoma after 1
year. The third (OT 200)' is alive in the ninth postopera-
tive month and has metastases. All patients with hepa-
tocellular carcinoma are alive. The tumors were enor-
mous in three cases. In the other four, the lesions were
smaller but could not be resected with conventional
techniques because of coexisting cirrhosis. It seems likely
that selected patients with hepatic or possibly biliary
duct malignancies can be effectively treated with trans-
plantation; however, no patient with duct cell carcinoma
has ever been cured (53, 122, 124). The prospects may be
more favorable for young patients whose hepatocellular
cancers could be treated with conventional partial hep-
atectomy were it not for coexisting cirrhosis.
Heroic efforts may be justifiable for patients with the
recently described "fibrolamellar hepatoma" which is
93
Vol. 2, No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
631
Table 18. Patients Treated for Endstage Benign Liver Disease Whose Removed Livers Contained an Unsuspected Primary
Liver Malignancy as Well. All Were Treated with Azathioprine, Prednisone, and ALG
Patient
Age
<yr)
Primary indication for transplant
Incidentally found liver ma-
lignancy
Survival
Tumor recur-
rence
OT 33 3 F Biliary atresia Hepatoma Alive 12% years
OT 80 7 F Biliary atresia Hepatoma Operative death
OT 142 5 F a- 1 -antitrypsin deficiency Hepatoblastoma Alive at 4V4 years
No
No
Table 19. Patients with Known Primary Liver Malignancy Whose Early Death After Transplantation Precluded
Observations of the Course of the Malignancy. All Were Treated with Conventional Immunosuppression Before 1975
Age
(yr)
Diagnosis
Survival (days)
Metastases at autopsy and lo-
cations
Main cause of death
OT2
48
M
Hepatoma, cirrhosis
21
No
Pulmonary emboli, sepsis
OT3
68
M
Bile duct carcinoma
8
No
Sepsis, pulmonary emboli.
(Klatskin's
i tumor)
gastrointestinal bleeding
OT4
52
M
Cholangiocarcinoma
5
Bone,
lung, kidney.
Pulmonary emboli, hepatic
cirrhosis
lymph nodes
failure, pulmonary edema
OT5
29
F
Hepatoma
24
No
Sepsis, bile peritonitis, hepatic
failure
OT6
29
M
Hepatoma
7
No
Hepatic failure, sepsis
OT7
24
F
Hepatoma
17
No
Pneumonitis
OT25
45
M
Hepatoma
29
No
Bile peritonitis, sepsis, hepatic
failure
OT79
60
M
Bile duct carcinoma
19
No
Hepatic failure due to biliary
(Klatskin's
tumor)
obstruction
characterized by indolent primary growth and late me-
tastases (125, 126). Three of our last 10 patients with
hepatic malignancy have had this diagnosis. In all three,
the tumors were massive. In one patient who was treated
more than 2 years ago (OT 172), a large tumor thrombus
originating in a hepatic vein was extracted at operation
from the vena cava and right atrium. He is tumor-free. A
second patient, who also is tumor-free after almost 1 year
(OT 194), had complete obstruction of the portal vein by
tumor. A third patient treated 2 months ago (OT 231)
developed recurrence in the residual lateral segment after
a right trisegmentectomy 4Vi years earlier. The tumor-
laden residual segment was replaced with a new liver
with a satisfactory result thus far.
At the moment, the prospects for cure seem bleak for
patients with duct cell carcinomas, and scarcely better
for those with unresectable conventional hepatocellular
carcinomas. Patients with smaller malignancies in livers
with other diseases, or those with fibrolamellar hepato-
mas may be more susceptible to treatment.
Recurrence of Other Hepatic Diseases
In pediatric recipients (Tables 8 and 10), recurrence of
nonneoplastic hepatic disease has not been observed. A
special feature of transplantation in the younger age
group has been the metabolic "cure" of at least five and
possibly six so-called inborn errors (Tables 8 and 10)
(126-131). With cyclosporin A, the prospects of using
transplantation to treat children with a variety of dis
eases has been heightened because chronic high-dose
steroid therapy can be avoided (132).
That the original disease can be recapitulated in hom-
ografts was demonstrated in adult recipients. Two pa-
tients with Australia antigenemia and chronic aggressive
hepatitis redeveloped their original disease and died
(133). Other patients with recurrent or newly developing
Australian antigenemia have lived for as long as 8 years
with the carrier state. It has been our policy to treat
HBsAG positive transplant recipients with hyperimmune
globulin postoperatively. Antigenemia has returned in
every case, sometimes after becoming undetectable for
months. With such treatment, Johnson et al. reported
permanent antigen clearing in a patient (134).
Recurrent primary biliary cirrhosis (135) as described
in the English series was not seen in five grafts studied at
autopsy after a few days to more than 6 months, and five
patients still living have had no evidence of recurrence in
spite of the reappearance of antimiochondrial antibodies
in the longest survivors (2W and almost 4 years).
We have treated three patients for the Budd-Chiari
syndrome. One (OT 174) developed the same disease in
the graft and died after 15 months. The terminal course
of this patient was triggered by unwise discontinuance of
anticoagulant therapy in preparation for a closed liver
biopsy. Calne et al. (53) reported a similar occurrence.
The Influence of Previous Operations
The technical problems engendered by prior surgery
have been so great that the Cambridge-King's College
Team consider multiple earlier operations as a relative
contraindication to transplantation. However, the major-
ity of candidates evaluated by us and the English workers
have had previous operations. The influence of this factor
was evaluated in the first 40 patients treated with cy-
closporin A and prednisone (Table 21) in whom the
results were more analyzable than in our earlier cases.
Fourteen of 40 recipients had major procedures on
portal triad structures (Table 21) including six portal-
systemic shunts and five biliary duct reconstructions.
The risk of death in the first postoperative month was
double that in patients with lesser or no earlier opera-
tions. There were two operative deaths (OT 176 and 180)
(Table 21) including one that occurred while trying to
94
632
STARZL ET AL.
Hepatolocy
Table 20. Patients with Primary Hepatic Malignancy. The Diagnosis of Neoplasia Was Known in Advance of
Transplantation Except in OT 176. Postoperative Survival Was at Least 2 Months for All But One Patient
Age
Diagnosis
Survival
(months)
Malignancy
factor in
death
OT8
[',:
F
OT 14
16
F
OT 15
43
M
OT23
15
M
OT26
11
F
OT45
53
M
OT78
48
M
OT90
41
M
OT 102
51
F
OT 111
9
F
OT 114
OT 121 32
OT 172
24
M
OT 176
33
F
OT 185
56
M
OT 194
26
M
OT 198
47
F
OT 200 27 M
OT 206 2 F
OT 227 53 M
OT231 23 F
OT 234
Hepatocellular cancer
Hepatocellular cancer
Precyclosporin Era
>13
>14
Hepatocellular cancer, cirrhosis >11
Hepatocellular cancer >4
Biliary atresia, hepatocellular cancer >2
Hemangioendothelial sarcoma >2
Bile duct carcinoma (Klatskin's tumor) >24
Bile duct carcinoma (Klatskin's tumor) >54
Bile duct carcinoma (Klatskin's tumor) >2
Tyrosinemia, hepatocellular cancer >3
Sarcoma (undetermined cell type) of liver >68 (Alive)
invading diaphragm, metastasis to right
lung and peritoneum
Hepatocellular cancer
>5
Cyclosporin Era
Hepatocellular cancer" >27
Sclerosing cholangitis, duct cell carci- >12
noma''
Duct cell carcinoma (Klatskin's tumor) >V6
Hepatocellular cancer" >1 1
Q-1-antitrypsin disease, cirrhosis, hepato- >9
cellular cancer
Duct cell carcinoma (Klatskin's tumor) >8
Tyrosinemia, hepatocellular cancer >7
Cirrhosis, hepatocellular cancer >3
Hepatocellular cancer", previous right tri- >2
segmentectomy
Hepatocellular cancer, cirrhosis >1
Brains, lungs, iiv"- i;er abdominal or-
gans
Diaphragm, retroperitoneal space, liver,
pancreas
Lungs, liver, diaphragm
Brain, lungs, liver, retroperitoneal space
Lung
Brain, lungs, liver, spleen, pericardium,
peritoneum, stomach, pancreas, kidney
Liver, bile duct at reoperation. No au-
topsy
Bile duct, liver, duodenum at reoperation
No autopsy
None
Microscopic metastasis in the lung and
paraaortic lymph nodes at autopsy
Grossly fine intraabdominal and pulmo-
nary metastases at time of transplan-
tation which have been quiescent for
5'/fc years
None
None
Liver, duct, peritoneum
None
None
None
Liver, operative wound
None
None
None
None
Main
Major
Main
Main
None
Main
Main
Main
None
Minor
None
Alive
Main
None
Alive
Alive
Alive
Alive
Alive
Alive
Alive
' Fibrolamellar.
s Diagnosis of cancer missed in surgical specimen, but diagnosed at surgical margin and within the native liver by reexamination 9 months
later.
Table 21. Influence of Previous Major Hepatobiliary
Surgery" Upon Results in 40 Consecutive Cases
(Cyclosporin Era)
No.
Survival (months)
>1
>2 >6
Previous major operation(s)"
No major operation''
14
26
10
22
10 10
21 19
n Six portal-systemic shunts (5 portacaval, 1 distal splenorenal). 5
bile duct reconstructions, and 3 portoenterostomies (Kasai).
* Previous exploration, open liver biopsy, cholecystectomy, T-tube
insertion, and splenectomy were not counted as major prior procedures
although the resulting vascular adhesions were usually troublesome.
Twelve of the 26 patients had one or more of these "minor" previous
operations including 4 cholecystectomies. 3 T-tube insertions, and 1
splenectomy.
take down a portacaval shunt. The portal vein after
portacaval shunt (especially side to side) may have sub-
optimal length and can be so sclerotic that suturing is
difficult or impossible. For patients who survive the first
postoperative month, the background of previous major
operations was no longer a factor (Table 21). These
results suggest that a prudent decision may be against
transplantation in patients with a complex surgical his-
tory, but that a "clean abdomen" is not a criterion of
selection.
THE OPTION OF AUXILIARY LIVER
TRANSPLANTATION
The alternative to orthotopic liver transplantation is
transplantation of an extra liver (auxiliary transplanta-
95
Vol. 2, No. 5, 1982
EVOLUTION OF LIVER TRANSPLANTATION
633
tion) without removal of the diseased native organ. Clin-
ical trials have been discouraging, as summarized by
Fortner et al. (136) from the compiled world experience.
Of nearly 50 well-documented auxiliary transplantations,
only one was an unequivocal success. Subsequently a
report from Paris described a second success (137).
Our opinion has been that auxiliary liver transplanta-
tion should be restricted to patients with potentially
reversible liver disease. In such a situation, the extra liver
could be construed as a temporary support organ which
can be removed later. However, we have encountered
increasing numbers of patients whose portal vein has
clotted in the hepatic hilum, making it technically im-
possible to consider liver replacement. Other candidates
are those with extensive previous surgery in the right
upper quadrant. Such patients can theoretically be
helped by an auxiliary liver transplantation, particularly
when the superior mesenteric vein or other distal tribu-
tories to the main portal circulation are still open. The
optimal conditions for vascularization of an auxiliary
liver graft require input from the portal circulation (2,
32, 138, 139), largely because of its high concentrations of
endogenous hormones.
DETERMINANTS OF THE FUTURE
The Question of Financing
Through 1980 in the United States, almost all liver
transplantations were performed in the Clinical Research
Centers (CRC) supported by the National Institutes of
Health. The fraction of the per case cost born by this
government agency shrank from year to year because of
the increasing willingness of many third party insurance
carriers to pay for part or all of the service. Third party
payments were collected by the institution and remanded
back to the National CRC headquarters which included
such collections as part of the total grant funding. In the
last years of the program at the University of Colorado,
approximately 85% of CRC expenditures for liver trans-
plantation were paid for in this way. By having CRC
support for the other 15%, it was not necessary to screen
candidates for their ability to pay. This creative practice
of federal and private cost sharing was conceived and
made practical by Dr. William DeCaesare, Director of
the Clinical Research Center Division, Bethesda, Md.
Thanks to the administrative leadership that flowed from
DeCaesare's office for more than 2 decades, almost all
modern-day techniques of immunosuppression and
transplantation of all organs, beginning with the kidney,
were developed on CRC units.
However, it is not reasonable to look indefinitely to the
CRC for support. So far, none of the liver recipients at
the University Health Center of Pittsburgh has been
treated on the pediatric or adult CRC. The principal
financing for their care has been from health insurance
programs or, less commonly, from private sources includ-
ing community fund raising. The collection rate for bills
has been greater than in the Colorado experience. With
the exception of Blue Cross/Blue Shield and some health
maintenance organization programs, the major health
insurance companies have willingly accepted their re-
sponsibility for liver transplant candidates providing they
were forewarned. The patterns of support from Blue
Cross/Blue Shield have been irregular, probably because
of their close association with MediCare.
It is ironic that government decisions or opinions have
impeded the movement of liver transplantation to the
private sector of medicine. A pronouncement by a state
or federal official of MediCare to the effect that liver
transplantation is "experimental" and not fundable has
often been the basis for a similar decision by regional
officials of Blue Cross and/or Blue Shield or by a cost-
conscious health maintenance organization. Even so, a
rapidly growing number of state (or Blue Cross) agencies
(including those in Pennsylvania, New York, and New
Jersey) have classified liver transplantation as a service.
In spite of the advantage of a preexisting federally
funded organ procurement network in the United States
as part of the End Stage Renal Disease Program, the
financing of liver procurement is not on a solid base.
There are no formal guidelines about how to proportion
the extra costs of removing extrarenal organs from a
multiple organ donor, or how to ensure against the po-
tential malpractice and other liability that could be in-
curred. Etna Life Insurance Company, the carrier for the
National Kidney Procurement Program, recently drew
attention to these policy gaps in a document that had a
chilling effect on some transplant coordinators.
The approximate average cost of a liver transplanta-
tion in Pittsburgh has been $55,000 (range $23,000 to
$150,000). The procedure offers hope of genuine rehabil-
itation. Dying of endstage liver disease with no hope of
real recovery may be even more expensive. O'Donnell et
al. (140) reported from Boston that the average cost of
nonsurgical treatment of patient for variceal hemorrhage
was $35,000. The use of any operative procedure in-
creased the total to $53,000. In many of our patients, the
expenses incurred during repeated hospitalizations before
transplantation dwarfed those incurred by transplanta-
tion itself.
The Potential Influence of Transplantation
Upon the Practice of Hepatology
Five to 10 years from now, we believe that every major
center for the treatment of liver disease will have either
transplantation capabilities or direct access to this kind
of service. The surgical techniques are within the grasp
of many practicing surgeons. The frequency with which
liver transplantation can be used will be great although
this has not been properly assessed. Our estimate is that
at least 20 centers will be required in the United States.
Knowledge that the provision of new liver tissue is a
realistic objective at the end of the line will influence
decisions about treatment. It will be increasingly impor-
tant to avoid major and often futile surgical operations
that jeopardize ultimate candidacy for transplantation.
Fortunately, there are alternative approaches. Sclerosing
therapy for the control of variceal hemorrhage instead of
portal diversion has become increasingly accepted.
"Interventional radiologists" often have been able to
ameliorate duct strictures in sclerosing cholangitis and
96
634
STARZL ET AL.
Hepatology
other diseases as effectively as can surgeons at open
operation. When procedures such as porticoenterostomy
(Kasai) are performed in infants with biliary atresia, it
will be worthwhile to avoid deviations from the standard
Roux-Y technique and multiple reoperations which make
transplantation difficult or impossible.
The presence of regional units undoubtedly will move
the timing of transplantation forward in the course of the
disease The fact that there has been a very high preop-
erative mo>: '.lity of patients accepted as candidates for
new livers is an indication of the lateness of referrals.
Throughout the years, many others have reached the
operating room in such appalling condition that there
was little hope of survival.
An avalanche of new scientific information should
become available to hepatologists and surgeons as the
result of progress in transplantation. Much has already
been learned about the synthesis of proteins whose origin
was not previously clear (2, 9, 141-143). Further improve-
ments in surgical techniques and immunosuppression
will increase the harvest. The history of medicine is that
what was inconceivable yesterday and barely achievable
today often becomes routine tomorrow.
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EVOLUTION OF LIVER TRANSPLANTATION
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99
Mr. Gore. Dr. G. Melville Williams, in addition to being profes-
sor of surgery at Johns Hopkins Hospital and a distinguished sur-
geon, is president of the American Society of Transplant Surgeons.
Dr. Williams, you, too have gone to a special extreme to be with
us today, rearranging your travel plans to Holland where you were
scheduled to appear before the International Congress on Organ
Procurement today. We appreciate the extra effort, and we look
forward to your testimony.
Dr. G. Melville Williams. Thank you, Mr. Gore.
It is possible to summarize national efforts in kidney transplan-
tation using round numbers, which are easier to remember some-
what more than 5,000 kidney transplants were performed last year;
of these, 30 percent of the kidneys came from related living donors;
3,300 kidneys can be expected to provide life-sustaining function;
2,500 individuals may be expected to return to work or to premor-
bid social activity; and, soberingly, 500 individuals die.
The key point is that through kidney transplantation with exist-
ing knowledge, one-half of the individuals transplanted return to
work, or their state of health before they got sick.
The analysis of data acquired by many collaborating centers
show that five variables have influenced the degree of success.
These variables are the center — some centers have excellent results
and some not so good — second is the number of blood transfusions
given the perspective recipient prior to transplantation; third is the
use of antilymphcitic serum; fourth, whether or not the kidney
functions immediately after transplantation; and fifth, the degree
of matching of donor and recipient. Knowledge of the influence of
these factors has been harnessed by most transplantation centers
with an improved overall national success rate increasing from 48
percent to close to 60 percent in the past year in organs recovered
from cadaver donors.
It is interesting to note at this point that what has been consid-
ered traditionally as a therapeutic endeavor, namely kidney trans-
plantation, reports results that are inferior to the results reported
by Dr. Shumway for heart transplantation, and slightly inferior to
the results that Dr. Starzl has published on liver transplantation.
It should be acknowledged that, in kidney transplantation, we
have, except for four centers, been unable to use the immuno-
suppressive agents available for use in these nonrenal transplants.
The point is that we have to redefine our concepts of what is ex-
perimental and what is not.
In the past, there has been some concern that patients with
kidney failure were denied access to transplantation systems. Vir-
tually all patients enter the system after having their lives sus-
tained by dialysis. Thus, referral to a transplant center is entirely
dependent upon the perception on the part of the patient and the
nephrologist caring for him that transplantation offers distinct ad-
vantages. With results improving and with the prospect of a real
breakthrough in the near future, this problem, I believe, will be
diffused and unimportant. Patients awaiting transplantation are
registered with the transplant center and undergo tissue typing
and screening for the presence of antibodies in their serum. The
presence of these antibodies informs the transplant surgeon that
the patient has had exposure to human tissues and has developed
100
some immunity to them through blood transfusions, pregnancies,
or other transplants.
Four centers in this country have had experience with the new
immunosuppressive agent, cyclosporine, in attempts to suppress re-
jection in renal allografts. All investigators agree that many of the
practices we have applied may prove to be obsolete when this drug
becomes available for general use, hopefully by the end of June or
the first part of July. This drug, used in combination with small
doses of Prednisone, promises to provide us with 80 to 90 percent
rates of success in cadaver donor transplants. The early concerns
about the development of cancer and of the potential toxicity of the
drug to the kidney itself have been ameliorated to some extent by
more recent experience.
Thus, the field of kidney transplantation is excited and restless
awaiting the availability of cyclosporine. As a nation, it behooves
us to plan our national strategy. I foresee four major problems con-
fronting us. First, research funding; second cost containment; third,
data acquisition and analysis; and fourth, increasing the rate of
organ donation — the fourth being the most significant.
It may be surprising to some of you in this room to know that we
are considerably behind our European colleagues in the application
of a crucial histocompatibility locus in tissue typing. It may be dis-
concerting to know that we do not know how to characterize our
black patients in terms of their tissue typing makeup nearly as
well as we how to characterize our Caucasian patients. Further, if
we could reliably preserve livers, lungs, hearts, for a period of 12 to
24 hours, considerable savings could be achieved in eliminating the
need for charter jet travel between the city identifying a heart or
liver donor and the transplantation center.
With respect to the kidney itself, where most of us feel the pres-
ervation problems are pretty well solved there is in fact the reality
that 25-45 percent of the kidneys transplanted fail to function im-
mediately—and this may be a very important point when using the
new agent cyclosporine — it has some deleterious effects on the
kidney — so without a monitor of toxicity, that is, some baseline
renal function, our success rates may well be jeopardized.
I wish to address the problem of cost and make two points. First,
there is the widespread notion which I think we should roundly
defeat that any new therapy is apt to be costly therapy. Regretta-
bly, this may be true in some instances, but in many others, this is
a very short-sighted view. As Dr. Starzl has already pointed out,
the treatment that we commonly give patients with liver failure
may be more expensive than the process that cures them.
In the case of transplantation, there was a recent directive from
the Health Care Financial Administration that it would not pay for
purposeful blood transfusions between a potential living donor and
the potential recipient of the kidney, a process which has led to 90
percent graft success, even in mismatched donor-recipient pairs.
The cost of giving the blood transfusion is one-third the cost of one
dialysis treatment.
Support must be given to agencies such as the Office of Technol-
ogy Assessment to develop a much more reasoned approach in our
application and evaluation of new methods of therapy and means
of financial reimbursement in this whole field of transplantation.
101
The second point regarding cost and transplantation is that,
purely in economic terms, long-term disability associated with ex-
pensive therapy costs more than death, which costs more than a
cure. One can do some simple calculations regarding the expendi-
tures required to sustain a disabled individual on hemodialysis.
We, the taxpayers, pay for the medical therapy and the social secu-
rity benefits accrued to the individual. We also lose taxes from the
loss of income. In the event of death, we are faced with paying
social security death benefits and we lose income from taxes. But
in the case of cure, we pay for medical therapy alone and recover
money from taxes in gainful employment.
As academicians, we commonly view our substantial rate of fail-
ure in kidney transplantation as the principal cost. However, re-
cently, Dr. Krakauer, in analysis of data at the NIH, has shown
through mathematical models that even if we increased the rate of
success of cadaver transplantation to 90 percent, we will do very
little to reduce overall costs of treating the patient with kidney
failure because the costs are principally related to chronic hemo-
dialysis. The only way costs can be substantially reduced nation-
wide is to increase the number of transplants performed, and I
would suggest that a target goal would be to double the number of
transplants in the next 5 years.
As we are now poised to enter a new era in clinical transplanta-
tion, it is important to know on a timely basis how we are perform-
ing. Despite the carefully conducted trials with cyclosporine, diffi-
culties may be encountered which are entirely unexpected. Our
current system of acquiring data — and this may help with the ques-
tion raised by our Congressman — is to obtain it from the transplant
centers via the networks that then forward the verified data to the
Medical Information System within the Health Care Financing Ad-
ministration. I have worked with this group. They are intelligent,
interested, highly-informed and hard-working people.
But those that are required to collect the data and assess it are
poorly supported monetarily. For example, any form that is distrib-
uted as a questionnaire to gain information must be processed
through OMB. This takes time. And any correction of that form,
such as searching for new toxicities related to cyclosporine, for ex-
ample, must go through the same process. So, between the time we
ask the question and get the answer, an enormous period has
lapsed and there will be no way to generate data on a national
scale without creating, I think, legislatively some funds to support
this either within the government or arranging contracts to inde-
pendent and interested individuals, such as Dr. Paul Tarasaki who
has maintained an ad hoc registry without due reimbursement for
long periods of time.
Lastly, and most importantly, there is this problem of increasing
the number of transplants performed. There has been a steady in-
crease, as I mentioned, from 4,721 transplants 4 years ago, to 5,358
in 1982. However, this trend cannot possibly meet the demand cre-
ated by improved results.
At one time — and I guess this was about 15 years ago — a study
was done which estimated that 50,000 individuals might die in the
United States each year at any age and of a disease compatible
with organ donation. A more recent conservative estimate places
102
this figure at 20,000. This is still immaterial, considering that only
2,000 become actual kidney donors. Is the reason for our failure to
obtain more organs the result of negative public attitudes or ineffi-
cient procurement systems? I think both.
With respect to attitudes, virtually every poll has indicated that
the majority of the American people are willing to donate parts of
, their body for transplantation if the results are good. However, the
mechanisms for opting into the system of organ donation are suffi-
ciently complex that, for example, in the State of Maryland, one
has to have two witnesses in order to sign an organ donor card to
put on your driver's license. At least 98 percent of the people re-
quested to do so have failed to sign up as organ donors. We have
never been called in a single instance from any emergency room in
which they have identified an individual with a card on their
person and asked us to proceed with organ removed for transplant.
From the organ procurement systems point of view, the decision
for organ donation is requested at the wrong time. When death is
sudden and accidental, there may be no time to locate and ap-
proach the family and no organs are removed. In a great majority
of instances, a family confronted with grief is asked to make an-
other contribution, and 30 to 75 percent of the families, when re-
quested, say no.
The role of the Government is, I think, very complex and contro-
versial. In a sense, we as a society have deemed that all patients
having kidney failure may be treated, and we pay for it. It is also
likely that the best treatment is kidney transplantation. Yet, while
all individuals would favor this type of therapy for themselves, we
consider attitudes favorable toward transplantation if a mere bO
percent canvassed state that they are favorably included toward
organ donation. It is what I call the "Henny-Penny syndrome,
where everybody wants to eat the bread and nobody wants to plant
the wheat. In the particular case of organ transplantation and
organ donation, the decision, pro or con, has to be made by individ-
uals at some point removed from the immediate grief of the cir-
PllTYlstflLTlC^S OT Q.63.LX1
If it is in the best interest of society to obtain the bullet in order
to find the murderer, I might ask, is it not also in the best interest
of society to obtain kidneys, hearts, livers, and pancreases to save
the lives and relieve the suffering of other individuals? In the case
of the bullet, the family has no option to deny autopsy and dis-
memberment. In the case of the heart and the liver and the lung,
the family persists in having the right, and we would defend that
right. But you see how discrepant we are in our circumstances.
Most recently in California, a law was passed which I hope re-
ceives due attention, and that is that, in cases that would come to
autopsy by the coroner or medical examiner, the coroner would be
empowered to remove the cornea unless there was expressed dis-
sent. So, from the ethical point of view— and I should add that sim-
ilar laws are present in Maryland, Florida and West Virginia.
(Maryland was the first State to pass such a law, I believe). The
decision has been made in favor of presumed consent. Yet, it we
were to proceed with this, normally I think it would shell shock
our Nation. So we have to proceed cautiously.
103
In Colorado, a State law exists demanding an individual to say
yes or no at the time of applying or renewing a driver's license.
The individual cannot ignore the question, I believe. So there is co-
ercion brought to bear on making the decision. At this stage, this
would be all, I think, that society would be willing to go with, and I
suggest simply that everybody think about this and make a deci-
sion for their own personal use in writing to have on their person.
In conclusion, I want to just make three points: The results of
kidney transplantation are improving and will improve further;
there is still the need for research, particularly in the field of
organ preservation; and a breakthrough is necessary for organ do-
nation to be viewed as normal and natural by the public. When
this occurs, we can truly celebrate a new era.
Thank you.
[The prepared statement of Dr. G. Melville Williams follows:]
104
KIDNEY TRANSPLANTATION 1982
THE STATE OF THE ART AWAITING A BREAKTHROUGH
It is possible to summarize national efforts in kidney transplantation
using round numbers as follows: somewhat more than 5,000 kidney transplants
are performed per year; of these, 30% of the kidneys come from related living
donors; 3,300 kidneys can be expected to provide life sustaining function;
2,500 individuals may be expected to return to work or to premorbid social
activity; and 500 individuals die.
The analysis of data acquired by collaborating centers show that five
variables influence the degree of success. These variables are: the center
performing the transplant; the number of transfusions given the perspective
recipient prior to transplantation; the use of antilymphocytic serum to
augment immunosuppressive treatment; the degree of matching of donor and
recipient; and whether or not the kidney functions immediately after trans-
plantation. Knowledge of the influence of these factors has been harnessed
by most transplantation centers with an improved overall national success rate
increasing from 48% to close to 60% for cadaver donor kidneys.
In the past there has been concern that some patients with kidney
failure were denied access to the transplantation system. Virtually all
patients enter the system after having their lives sustained by dialysis.
Thus, referral to a transplant center is entirely dependent upon the perception
on the part of the patient and the nephrologist caring for him that trans-
plantation offers distinct advantages. With results improving and with the
prospect of real breakthrough in the near future, this problem, I believe,
will be diffused. Patients awaiting transplantation are registered with the
transplant center and undergo tissue typing and screening for the presence of
105
antibodies in their serum. The presence of these antibodies informs the
transplant surgeon that the patient has had exposure to human tissues
and has developed some immunity to them through blood transfusions, pregnancies,
or other transplants.
There is great variation in the organization of transplant centers.
Historically, transplantation was an acknowledged experimental procedure which
could be performed only in hospitals affiliated with strong university programs.
In a given metropolitan area in the east, there may be four or five active
transplant centers vying for the treatment of patients. In other areas par-
ticularly in the mid and far west, there may be only one transplant center
providing services to an enormous population. The location of the center
and how crowded it is with other centers determine practices and the need for
collaboration. In order to perform transplants, every center must have some
means of obtaining transplantable organs and of determining the degree of
match and the likelihood of success if a given organ is used for a given
patient. If a center is treating 600 dialysis patients awaiting transplantation,
clearly it can develop efficient organ procurement programs, tissue typing
laboratories, community education programs, etc. If a transplantation center
is serving the needs of 100 patients awaiting transplantation, it must
affiliate with other centers, for the kidneys it obtains are frequently incompatible
with its own patients.
Four centers in this country have had experience with the new immuno-
suppressive agent, Cyclosporine, and all of these investigators agree that
many of the practices we have applied may prove to be obsolete when this
drug becomes available for general use. The drug used in combination with
106
small doses of Prednisone promises us with 80 to 90% rates of success in
cadaver donor transplants. The early concerns about the development of
cancer in long-term recipients and of the potential toxicity of the drug
to the kidney itself have been ameliorated to some extent by more recent
experience. Cyclosporine will not abrogate existing antibody levels
from previous exposure so that some individuals awaiting transplantation
may wait long periods of time before a donor is identified to whom the patient
is not immunized. For these patients and for others who have a concerned
family member, related living donor transplantation is a valid option. A
second breakthrough has occurred in this area, namely that of using blood
drawn from the potential donor given to the potential recipient as a means
of conditioning the recipient for the kidney transplant. Recipients who have
sustained three small blood transfusions from their potential donor have
enjoyed 90% graft survival rates despite being imperfect tissue matches.
This degree of success has led to greater numbers of volunteer donors and
may even lead to successful grafts between a husband and a wife, for example.
Thus, the field of kidney transplantation is excited and restless
awaiting the availability of Cyclosporine. As a nation, it behooves us to
plan our national strategy as we apply these technological advances. I
foresee four major problems confronting us: 1) research funding; 2) cost
containment; 3) data acquisition and analysis; and 4) increasing the rate of
organ donation.
While we anticipate substantial improvement in graft and patient survival
in the near future, it must be acknowledged that the long-term effects of
Cyclosporine are not known, and there still must be more precise means for
controlling the immune response. Basic '"scientists in immunology have developed
107
exquisitely specific means for monitoring and controlling some immune
responses. This technology using monoclonal antibodies has yet to be
harnessed in clinical transplantation.
It may be surprising to some to know that we are three years behind
our European colleagues in attempting to match donor and recipients for the
Dr antigen system which promises to be more important than the systems
commonly in practice. We know much less about how to characterize Blacks
for tissue typing, and we know very little about how to extend the period
out of the body for organs other than the kidney. If we were able to
preserve these organs reliably for periods of 12 to 24 hours, considerable
savings could be achieved by eliminating the need for charter jet travel
between the city identifying a heart or liver donor and the transplantation
center. With respect to the kidney itself, much is known about preservation.
Yet, 25% of cadaver kidneys fail to function immediately after transplantation
and this is very important when using Cyclosporine. As a nation, we have
decried the expense of caring for patients with kidney failure while forgetting
that research and development funds are always necessary to provide better
solutions.
The problem of cost containment is one that concerns many of us in
transplantation and there are two points to be made. First, there is a
widespread notion that new therapy is costly therapy. Regrettably, this is
true in many instances, but in many others it is quite short-sighted. For
example, there was a recent directive from the Health Care Financing Adminis-
tration that it would not pay for purposeful blood transfusions in the living
donor situation described. The charge for drawing a unit of blood and dividing
108
it into thirds for subsequent transfusion is one-third the charge of one
dialysis treatment and the result may be a 90% successful outcome of the
transplant. Support must be given to agencies such as the Office of
Technology Assessment to develop a reasoned approach in the application
and evaluation of new methods of therapy and means of reimbursement in the
field of transplantation. The second point regarding cost and transplantation
is that in purely economic terms, long term disability associated with
expensive therapy costs more than death which costs much more than a cure.
One can do some rather simple calculations regarding the expenditures
required to sustain a disabled individual on hemodialysis. We, the taxpayers,
pay for the medical therapy and the social security benefits accrued to the
individual. We also lose taxes from the loss of income. In the event of
death, we are faced with paying social security death benefits and we lose
income from taxes. In the case of cure, we pay for the medical therapy but
recover money from taxes.
As academicians, we commonly view our substantial rate of failure as
the principal cost in transplantation. Recently, Dr. Krakauer at the N.I.H.
has shown through mathematical models that even increasing the rate of cadaver
donor transplant success to 90% will do very little to reduce overall costs
of treating patients with kidney failure. The only way costs can be sub-
stantially reduced is by increasing the number of transplants performed.
As we are poised to enter a new era in clinical transplantation, it
is important to know on a timely basis what our performance is. Despite the
carefully conducted trials with Cyclosporin, difficulties may be encountered
which are entirely unexpected. Our current system of acquiring data through
109
the End Stage Renal Disease Networks and from the networks into the
Medical Information System of HCFA is poorly supported. As a group, the
individuals responsible for the creation of the forms and for their
collection and analysis are highly motivated, intelligent and hard working.
Yet, the system lacks monetary commitment and quick response. For example,
in order to modify the forms and acquire new information regarding Cyclo-
sporine toxicity, a process involving 0MB must be engineered. One
recommendation we can all make to this committee is that a stable data
acquisition and analysis group be formed. This duty can be performed by
the private sector through contract mechanisms as well as by creating a
division within a given government agency.
Finally, there is the problem of increasing the number of transplants
performed. There has been a rather steady increase over the last four years
from 4,721 to 5,358. This trend if continued will not meet the demands
created by improved results. At one time, it was estimated that as many as
50,000 individuals might die each year at an age and of a disease compatible
with organ donation. A more recent conservative estimate places this figure
at 20,000. This is still immaterial considering that only 2,000 become
actual kidney donors. Is the reason for our failure to obtain more organs
the result of negative public attitudes or inefficient procurement systems?
I think both.
With respect to attitudes, virtually every poll has indicated that the
majority of the American people are willing to donate parts of their body
for transplantation. However, the mechanisms for opting into the system
of organ donation are sufficiently complex that only 2% of the individuals
given the opportunity at the time of signing their Driver's License in the
Tl_mo r\ _ ai
110
State of Maryland become organ donors. From the organ procurement systems
point of view, the decision for organ donation must be made at the time of
death and the decision is made by relatives not the individual. When death
is sudden and accidental, there may be no time to locate and approach the
family and no organs are removed. In a great majority of instances, this
is the wrong time to make a rational decision, and 30-75% of the families
say no.
The role of government in altering our system particularly our timing
to make this important decision of organ donation remains most controversial.
In a sense, we as a Society have deemed that all patients having kidney
failure may be treated. It is also likely that the best treatment is kidney
transplantation. Yet, while all individuals would favor this type of therapy
for themselves, we consider attitudes favorable toward transplantation if
a mere 60% canvassed state that they are favorably inclined toward organ
donation. As a Society, we have denied individuals the right to decline
autopsy in cases of homocide, suspected suicide and in some accidental deaths.
If it is in the best interest of Society to obtain the bullet in order to
find the murderer, is it also not in the best interest of Society to obtain
kidneys, hearts, livers, pancreas, etc. to save the lives and relieve the
suffering of other individuals? In certain states, laws have been passed
enabling the coroner's office to remove the cornea, unless there is expressed
dissent, for transplantation from bodies that will be autopsied. Thus, we
are entering into an area where the ethical position has already been
clarified. What has to happen from now on is a gentle boost in public
i^nscioucness together with properly timed coercive steps. I have in mind
Ill
a goal demanding individuals to state yes or no to organ donation at the
time they renew their Driver's License without the need for witnesses and
with full legal recognition that a transplant surgeon may proceed to
remove organs from an individual carrying a "yes" card without the fear
of prosecution.
It is likely that an ever increasing demand for transplantable
organs will focus public awareness and agreement so that what appears
to be coercive now will not be in two years. It is my hope that greater
interest in death and dying and the continuation of life will be addressed
in medical and pastoral education. Because organ donation is a salutary
and comforting process for families, it is our obligation to take away the
agony of the decision at a time of maximal grief and provide them with
the knowledge that something positive has come from such a tragedy. I
believe that this will become a new responsibility of every transplant
service.
In conclusion, there are three points to be made: 1) the results
of kidney transplantation are improving and will improve further; 2) there
is still the need for research, particularly in the field of organ preserva-
tion; 3) a breakthrough is necessary for organ donation to be viewed as
normal and natural by the public. When it occurs, we can truly celebrate
a new era.
112
Mr. Gore. Thank you, Dr. Williams.
I suppose the single most important thing that could be done to
help solve the problems that you three doctors encounter is for
American citizens to say to their family members in conversation
that, "If tragedy ever occurs and I am in a situation where my kid-
neys or heart or lungs or liver could help someone else to live, I
would want you, as my next of kin, to make those organs availa-
ble." Is that the single most important thing that could happen?
Dr. Shumway. Yes.
Dr. Starzl. Yes.
Dr. G. Melville Williams. Yes.
Mr. Gore. How many lives— let's say, for example, that today or
tomorrow people in this country had conversations around the
breakfast table or the dinner table and said to each other, "Look,
let's agree as a family we think this is important. This will be our
policy as a family." Let's just imagine that every American in the
country did that, and you didn't encounter that obstacle, how many
lives would you estimate you could save as a result?
Dr. G. Melville Williams. Thousands. If we can raise public
consciousness to the extent where they make the demands of the
physician taking care of their loved one during the dying process,
as is happening — this is beginning now — then we really will have
made a big step. Part of the problem is the problem with the doctor
identifying and engaging the donor and the family in the process of
organ donation, I believe.
Mr. Gore. So doctors and nurses and hospitals have a role to
play in making families aware of what the opportunity is for hope
and joy to be born of tragedy and for them to make available
organs that are greatly needed to sustain life elsewhere. Do you
find that many doctors and nurses and hospitals just aren't aware
of how great this need is?
Dr. Starzl. I think it is a double problem. I think perhaps the
doctors and the nurses are aware of it, but it is a kind of a positive
or affirmative action that can easily be cancelled if the lay public
doesn't reinforce. And I think it works the other way around, that
if the lay public will take the first step, then the physicians and
nurses will reinforce that. But they have to work together.
This syndrome that has been described of the families demand-
ing that organs be used and really bringing it up for the first time
is becoming very common. But I have seen it, going back for 20
years. It really was how the whole organ donation concept came
into being in the first place. Interestingly enough, some of the first
cases that I remember were children of physicians who did not
want that vital resource to go to waste and having now realized
that their child was brain dead.
Mr. Gore. These other problems which we will be attacking are
likely to have less impact on the solution to the problem, of the
overall problem, than that raising of awareness among the Ameri-
can public about how important this is. But they need to be solved,
too, these other matters, and in the process of solving them, we
may be able to contribute to making people more aware of how im-
portant organ donation is.
Let me just briefly give you my thumbnail understanding of
what this situation is and ask you to agree or disagree. No. 1,
113
through a combination of your skill and the accumulated knowl-
edge in the medical profession and this remarkable new drug
called cyclosporine A, which is the latest and most important in a
series of measures that make rejection almost a thing of the past,
we have entered a new era of organ transplantation; there is no
question about that, is there?
Dr. Starzl. No.
Dr. G. Melville Williams. No.
Dr. Shumway. No.
Mr. Gore. The public is quite aware of the efficacy of kidney
transplants. But, in fact, Dr. Starzl, there are as many cases of end-
stage liver disease as there are of end-stage kidney disease — almost
as many — are there not?
Dr. Starzl. I think it is in that order of magnitude, or perhaps it
would be two-thirds as common as end-stage renal disease. But he-
gatic disease is the fourth leading cause of death in the United
tates at the present time, or it ranges between third and fifth.
Mr. Gore. So the potential for the successful procedure you have
pioneered is equal to the potential — or nearly equal to the poten-
tial— of kidney transplantation?
Dr. Starzl. It is going to have a broad application. I don't think
there is any doubt about it.
Mr. Gore. Now, the reason the public awareness of liver disease
does not approach the public awareness of kidney disease is that
there is no equivalent for dialysis that keeps large numbers of liver
patients alive for many years, they die if they don't get a trans-
plant.
Dr. Starzl. Yes; Mr. Skeen brought back sad memories, as I al-
ready said, of 20 years ago. In 1962, chronic artificial kidney treat-
ment was available for six patients in the United States and in the
world. Those six patients were all at the University of Washington
under Scribner, where the technology of chronic artificial kidney
treatment was really just coming out. That is the way things were
then. But, of course, that changed.
As Dr. Shumway said, I don't think the prospect of changing
with hearts or with livers, where the functions are even more com-
plex, is really a realistic hope for the immediate future, or perhaps
ever. That means that the urgency for the organs that we are look-
ing for now is far greater than it is for the kidney, and it will prob-
ably continue to be that way.
I think that no renal donor should fail to be considered for the
need of extra-renal organs on the spot. I think that is an important
thing, and the transplant coordinating groups, I believe, are really
working on that.
Mr. Gore. It is certainly a tragedy that demands a response.
I wonder if I might just ask people to raise their hands. How
many parents or close relatives of children in these circumstances
just heard about these hearings today and came out? Could you
raise your hands?
[Show of hands.]
Mr. Gore. There are several people. I noticed several children in
the audience. Thank you.
I know that we have had circulated to us a number of pleas from
families for assistance from all over this country.
114
The label "experimental," isn't accurate when applied to either
liver transplants or heart transplants; would both of you agree?
Dr. Starzl. Absolutely. Or heart-lungs.
Mr. Gore. Let's talk about heart-lungs for a second. The reason
you transplant the combination of lungs and heart — it is triggered
by the need to transplant the lungs — but if you transplant the the
lungs alone, you cannot accurately monitor the onset of rejection.
Dr. Shumway. Correct.
Mr. Gore. But by transplanting both the lungs and the heart as
a system, you can put in a catheter that allows you to monitor and
control the rejection process and get roughly the same success rate
as you do with the heart alone; is that correct, Doctor?
Dr. Shumway. That is correct.
The X-rays after a lung transplantation are so ambiguous that
one wouldn't know whether it was rejection or atelectasis or pneu-
monia or pulmonary edema. But with the heart on the system as
the monitor of these events, then we can, by taking a little piece of
the heart out in a very simple manner, look at it under a micro-
scope, and tell exactly what is going on with respect to the health,
not only to the heart, of course, but of the lungs as well. So this
has made the whole thing extremely feasible. I think it has out-
moded completely any future application of unilateral lung trans-
plantation.
Mr. Gore. I see.
So the label of "experimental" is just inappropriate today?
Dr. Shumway. I think it is a convenient label to use for anything
that the third-party carriers or the Government doesn't wish to
support financially.
Mr. Gore. Yes. That is laying it on the line, Doctor.
You said something astonishing in your testimony, that you
haven't had a single case of rejection?
Dr. Shumway. Rejection that is notable from the standpoint of
clinical inspection or examination of the patient. The only way
with cyclosporine A that we have been able to tell if there is a re-
jection process going on is through the biopsy of the heart.
Mr. Gore. I see. That allows you to calibrate the amount of the
drug that is used.
Dr. Shumway. Right. And it allows us to intervene at a time
which is much earlier than in the past, before any severe damage
to the transplanted organ has occurred.
Mr. Gore. I understand this drug was discovered by Sandoz Lab-
oratories having a policy of having its employees bring back soil
samples from vacations; is that correct?
Dr. Shumway. That is what I understand, yes.
Mr. Gore. And one of them came back with a soil sample from
somewhere in Scandinavia and they ran it through the tests and
just discovered this in the ground somewhere?
Dr. Shumway. That is right. Then it was applied experimentally
in Cambridge, and then clinically as well, and it is now available,
and I was surprised to hear, in only four renal transplant units. I
didn't understand that at all.
Dr. Starzl. In Cambridge, the drug began to be used in the late
spring or early summer of 1978. It was released in this country to
the group at Harvard and to us for kidneys in late 1979, and then
115
Houston and Minnesota about 9 months after that. So those are
the four.
There is a multicenter trial going on in Canada, however, and a
multicenter trial in Europe, the results of which, in both instances,
have been reported and showing a marked advantage for the cyclo-
sporine.
Mr. Gore. So that has made rejection virtually a thing of the
past. It still has to be monitored carefully and watched, but, as a
source of failure, it is virtually a thing of the past.
Dr. Starzl. It has certainly been enormously reduced. It has just
about doubled the survival of organs it has been used for.
Mr. Gore. I know that there are still some questions that have to
be answered about potential side effects, but this is truly a miracle
drug and, combined with your magnificent skill and the advances
in the medical profession generally, we have created — you have
created — a new era for transplant patients. As you said, Dr. Wil-
liams, we desperately need a national strategy for coping with the
onset of a remarkably increased demand for organs for transplan-
tation, and we have a bioethical imperative to develop such a na-
tional strategy.
It is not only bioethics involved, as you know, Dr. Williams, it is
also cost effective. The NIH has estimated that up to $300 million a
year, most of it in Federal funds, could be saved if we doubled the
number of kidneys available for transplantation and equal savings
could be found from the transplantation of other organs.
I want to apologize to my colleagues for taking so much time. I
will come back for more questions on the second round.
Congresswoman Schneider.
Mrs. Schneider. Doctors, I am a very strong advocate of preven-
tion, and I can't help but wonder, since most of our discussions
have centered around small children and the diagnosis of the liver
diseases coming something like 2 weeks after birth, is there some
research, or have we already determined what are the causes of
the diseases we have been talking about?
Dr. Starzl. In many of the pediatric diseases, genetic counseling
might help prevent somebody being born with a genetic taint. The
fact of the matter is that something like six or seven of these so-
called in-born errors have now been effectively treated with livers,
because if the in-born error is a basic enzyme deficiency of the liver
or hepatic based in other ways, possibly because of enzymes miss-
ing that you don't even know about, the provision of a new liver
from a normal person will provide a permanent cure. In other
words, if you get my liver and you have got some flaw in yours that
is genetically determined, you will always have the function of my
liver, and it will make up for what you are missing. But that is cu-
rative. If you took the same diseases — there are, I think, seven of
them now that have been treated in this way — it might be possible
to prevent them.
The most common pediatric disease is biliary atresia. That is not
a genetically determined disorder. It is a disease that affects about
1 — these figures vary somewhat — but perhaps 1 in 8,000 births. I
calculate it out that, in the United States, that means we are pro-
ducing about 500 new biliary atresias each year. It is those children
with biliary atresia who are providing most of these anguished
116
calls that you are getting, or many of them. Because they tend to
be very attractive children, they receive an enormous social eco-
nomic and medical input and, in the long run, there is no dividend
unless something decisive can be done.
But I think that is not a preventable disease. I don't really know
what causes it. Although there is a lot of speculation about it, I
don't think there is any information on it.
Mrs. Schneider. Is there some kind of research going on now
into the cause?
Dr. Starzl. I think there is a good deal of research, but there are
no leads, to my knowledge.
Just to show you where basic research can sometimes lead, a
very bright pediatrician named Harvey Sharp at the University of
Minnesota in 1967 discovered that alpha-1-antitrypsin disease had
an association with hepatic disease— it was known previously to be
associated with pulmonary disease. That one little discovery has
opened up an enormous Pandora's box of new information and has
made it possible, in some instances, to carry our prophylaxis be-
cause alpha-1-antitrypsin disease, as it turns out, is one of the lead-
ing causes of neonatal jaundice. That all has only been known
since 1967.
Mrs. Schneider. Part of the reason I am asking is because the
Science and Technology Committee, of which we are a subcommit-
tee, has responsibility for the budget of many of the basic research
programs that are going on, both in the Federal institutions and
also in many of the universities.
We have been talking mostly about children and liver trans-
plants. Are there many adults who are in need of liver trans-
plants?
Dr. Starzl. Yes, I think that two-thirds of the candidates, exclud-
ing the alcoholic population— just the ones that we have been
about to treat— have been adults. It is a crippling disorder. Alpha-
1-antitrypsin disease pops up in adult life as well. But I won't ever
bore you with a list. It is a tedious list of indications or of diseases
that are nonalcoholic and cause end-stage liver disease. They affect
people of your age, young people who are vital
Mrs. Schneider. Flattery will get you everywhere.
Dr. Starzl. It does affect people in the 20, 30, and 40 age range.
Our upper limit for liver transplantation in adults has been pretty
much arbitrarily set at 50 to 55.
Mrs. Schneider. And it is possible to transplant the liver to a
person who has alcoholic cirrhosis?
Dr. Starzl. Yes, without disclosing a name, our longest patient is
about a decade with alcoholic liver disease, and this was a pretty
well-known professional football player at one time who has never
had a drink since that time and has become a major drug abuse
and alcohol rehabilitation officer in one of the important States.
Also we did a man who became the chief of an Indian tribe. We did
him 7 or 8 years ago.
So I don't think that, out of hand, one can exclude for future con-
sideration alcoholics. We already know that the incidence of recidi-
vism is rather small in people, even people in the alcoholic popula-
tion, providing careful screening is carried out and there is some
evidence of abstinence in advance from alcohol.
117
Mrs. Schneider. Do liver transplant patients require life-long
monitoring or constant treatment?
Dr. Starzl. Yes, but it is a very simple situation. I am glad
Danny Butler is here, because we see him about once a year, and I
suppose he sees his doctor here about once every couple of months.
He really just lives a normal life. The people that get out months
or so after transplantation can do well, just like Norm's famous pa-
tient who got on a bicycle and rode it from coast to coast. They are
not strange. You wouldn't even be able to recognize them if you
met them on the street.
Mrs. Schneider. You had mentioned in your testimony, Dr.
Starzl, that at times it is easier to operate, and one finds operating
better in both Europe and the Far East. I wonder if you could
elaborate on that.
Dr. Starzl. There are a number of centers in those parts of the
world. Some of them will make depositions at the Consensus Con-
ference— Rudy Krom in Holland, a group working in Munich, and
a group working in France. They all are representatives that at
one time trained with us. Then we have trained people in
Japan
Mrs. Schneider. But you mentioned that it was sometimes easier
to operate in foreign countries. I was wondering if you were imply-
ing
Dr. Starzl. No, I just meant that they have had an easier time
setting up programs. For example, Italy just made a decision that
they were going to set up three transplant programs, one in Milan
which is on its way, one in Rome, and the third one in an unspeci-
fied city about which they are presently struggling. But it is known
there that there are going to be some centers, and they have been
set up. They are not research centers, they are service centers. I
think that is going on in Italy, in France, in Germany, in England,
and so on. England, I think, has now got a second one.
I think we are behind in our regionalization, if you will, in
making it feasible to go forward. That is the trouble that Jim Wil-
liams has gone through. What he has done has been perfectly ex-
traordinary.
Mrs. Schneider. In the Modern Medicine magazine in April a
few years ago, you were interviewed and you had said that now
you have solved the problems of supply and duct integrity; you are
now looking for better immunosuppressive techniques to improve
the survival rates of transplant patients. This interview was con-
ducted back in 1976, and I wonder what the timing was for the in-
troduction of cyclosporine?
Dr. Starzl. Cyclosporine surfaced with a paper given by Jean
Borel, the Sandoz immunologist, in 1976, and was seized upon by a
man named Dave White working at Cambridge. An experimental
supply became available in 1977 in Europe. Many people around
the States knew about it. We did. But you really couldn't get it. It
was priceless at first.
Mrs. Schneider. Now I understand that the process to manufac-
ture it is a rather cumbersome ordeal. I wonder if you could elabo-
rate on how expensive it might be?
Dr. Starzl. I am told by the people in the company it will cost
for a patient for a year $5,000 or $6,000, something in that range.
118
Mrs. Schneider. For a year.
Dr. Starzl. I am not sure that they would really want me to say
anything, and I have nothing to do with the company. This was a
question, though, that was asked at the FDA meeting here 2 or 3
weeks ago, and that was the answer that was given in a public
forum.
But, as Norm said, it has been synthesized. A man named
Wenger synthesized it. It is thought that analogs will be forthcom-
ing. The problem with the synthesis presently is about the same as
with penicillin many years ago, in that the synthetic process is
cumbersome and takes about 35 steps. I am told that to be commer-
cially feasible, it has to be in five steps or less.
So, at the present time, it is a biologic preparation. It is an ex-
tract from some fungi. You have to grow those fungi and then col-
lect the extract, and so forth. I think it is cumbersome, but it
almost certain to become simpler as time goes by.
Mrs. Schneider. Fine.
I would like to personally thank you, Dr. Starzl, for your efforts
last night and this morning. The operation that he was involved in
was on one of my constituents, and I am very appreciative for your
personal involvement and oversight in this case. I am hopeful that
very soon she will be in good shape.
I thank all of you for your very informative imput.
Mr. Gore. Congressman Durbin.
Mr. Durbin. Thank you very much, Mr. Chairman.
I, several years ago, worked with the Illinois State Senate Judici-
ary Committee, and we put together the Uniform Anatomical Gift
Act in the State of Illinois, and tried to set up a procedure through
our driver's license, I think, very similar to what you described
today, to increase public awareness. I don't know how successful it
has been in our State.
After hearing your testimony, I am wondering if all of our efforts
in that regard, aside from increasing public consciousness, made it
any easier for you as a surgeon looking for a donor to have people
available when you need them. Has it worked? Is it still too cum-
bersome?
Dr. G. Melville Williams. Yes, it is far too cumbersome.
What, I think, would help would be to have many of the so-called
safeguards removed. For example, why is it necessary for an indi-
vidual to have two witnesses in order to make a statement "yes" or
"no" if he wants to donate his body for transplantation?
Mr. Durbin. I can tell you why, but it still doesn't make any
sense.
Dr. G. Melville Williams. Yes, I know. You see, we make it
very, very hard to opt into the system. There is plenty of evidence
to state that, given a choice, 2 percent of the people go to the time
and trouble of filling out the forms, getting their witness — which
might be strangers in the line waiting to apply for their driver's
license — I did that once, and everybody thought I was a nut.
Dr. Starzl. It can be done simply. I worked in Colorado for a
number of years, about 19 years, and it was no accident that that
driver's license law that was described earlier was in Colorado. But
that didn't require witnesses. You expressed an opinion as you
went through. Now, that probably did not carry the legal weight
119
that the Maryland document does. The Maryland document pre-
sumably would allow the doctor to go right forward without any
family permission, and I never construed the Colorado document
that way.
But what it did do was to create an ambience within the family
so that everybody knew that this guy checked that off — almost
always yes — and at the last count when I left there, there were
about a million of the driver's licenses in Colorado that had been
checked off— yes.
Mr. Durbin. Does that work, though, States like Colorado?
Dr. Starzl. I don't think it works in terms of a point-to-point
procurement. But I must say that there were a lot of donors in
Colorado. It was a very, very effective donor center, one that was so
effective that, for a long time, it was one of the main sources of
kidneys for New York City and also for the west coast. It was a
very effective center.
But that all is kind of nonspecific. I will bet you anything that
they are busier than heck out in San Francisco because, whenever
extra-renal organs get into the picture, they attract a lot of atten-
tion. It automatically gears up the kidney procurement. It really
helps. So these are reinforcing procurement problems, the renal
and the extra-renal ones.
Mr. Durbin. Many Members of Congress write weekly columns
and send them back home about things we do in Washington. I
would like to write a column about this testimony today. I would
like to end it by making specific recommendations to the people
that read it. I am trying to, from your testimony, come down to
some very basic things that everybody could do, having heard what
is needed and really appreciating what they can do.
I think that the first thing — and Chairman Gore deserves com-
mendation from all of us, because there are plenty of things that
we could be talking about and I can't think of anything more im-
portant today, and he in his effort has increase public awareness —
but as he mentioned earlier, just sitting down with member of your
family, and at least have an understanding about what your per-
sonal feelings are so that, if there is an accident where your life is
threatened or a fatal accident, they will have an idea what decision
to make. That sounds like a pretty valid first step.
I guess the second one is — I looked at may own driver's license
and, having worked on that law, I never signed the back of it on
the donation of organs because I was never asked in line and it
never crossed my mind. It seems to me that we ought to be more
conscious when we renew our driver's licenses about these provi-
sions in some States, and perhaps contact legislators in some States
that don't have this law.
Would the third thing be to contact local medical societies and
ask them what kind of organ donor societies are available or associ-
ations? I have been contacted at church picnics about donating my
organs.
Dr. Starzl. I think that is an important thing to do. It is curious
that I never really took the necessary effort to do it voluntarily. I
was asked to do it by the Journal of Pediatrics. This was involving
an interest in which I had a major investment, that is the liver
120
transplantation, because the small donors, as you have heard this
morning, are the ones who are in short supply.
At the same time, in a quite formal surgical literature, many
papers are now coming out. As you pointed out, Mel left a very im-
portant meeting in Holland that was considering some of these
questions. Studies were being reported at the meeting about the
function of different organs when taken out in conjunction with
other organs. That is in the literature, and it is apt to increase the
physician awareness.
Just so you know exactly what I am talking about, we heard
from Mel that the national incidence of failure of kidneys to func-
tion promptly is rather high, 30 to 35 percent, in that range. But in
the heart donors, at least in the Eastern half of the United States,
that figure is less than 10 percent for malfunctioning kidneys, and
in liver-plus-heart-plus-kidney donors, it is the lowest of all, prob-
ably in the order of 5 to 10 percent.
What this really means is that the removal of these extra organs
does not jeopardize the kidneys at all. As that kind of information
gets out, I think it will automatically impact on the physician ac-
ceptance and acceptance by the kidney transplant surgeons.
Mr. Durbin. What can the average person do to help along in
this physician awareness? Is it a waste of time to write a letter to
your local medical society and say that I hope you are participating
in some sort of education program?
Dr. Starzl. I think that is going to have to come from us. We
have been negligent. Mel, by virtue of being president of the
American Transplant Society— which has an educational arm —
should be able to do something. I think that we are going to have
to work on that, because we are asking you to do things we are not
even doing our own homework on, it looks like.
Dr. G. Melville Williams. Doesn't the Emergency Medical Serv-
ice— isn't that a federally sponsored program?
Mr. Gore. They get some assistance, yes.
Dr. G. Melville Williams. I remember several years ago trying
to drum up interest, stating that within that system there be devel-
oped some guidelines for the recognition of donors. As it stands
now, I don't believe that that is done. In other words, this is some-
thing that is within the boundaries of Federal enterprise.
Mr. Gore. We are going to hear a specific recommendation on
that from a witness tomorrow, and we anticipate including that in
our lengthy list of recommendations when we report at the end of
the 3 days of hearings. I think that is an excellent suggestion.
Mr. Durbin. Dr. Shumway, could I ask you a question or two
here? I am particularly interested in some aspects of your testimo-
ny.
Is there a rather free exchange now of information among coun-
tries that are interested in transplantation?
Dr. Shumway. Yes; there is. I know more, of course, about hearts
and lungs, and so forth, than the others, but most of the people
who are interested in developing these clinics doing transplant of
the extra-renal organs such as heart or heart-lungs are people who
have been through our place and who spent time with us. And
there is a free exchange of information.
121
Mr. Durbin. Do you feel there is any resistance within the medi-
cal profession to the idea of transplantation? I got the impression
about 10 years ago in speaking to a heart surgeon that the idea of
transplantation was something that was considered too experimen-
tal, at least in the heart area. Has that changed remarkably?
Dr. Shumway. I think it is changing. I think the good results
that are currently possible have pretty much dispelled all of that
original doubt, but there are still units, though, that, for one
reason or another that are very difficult to understand, are having
trouble with the survival statistics — after transplantation of the
heart, for example. But this is less and less of a problem. Today,
there must be a half a dozen centers in Europe that have good pro-
grams in heart transplantation, and probably 12 to 15 such centers
in the United States.
Mr. Durbin. Can we look to the day in the next 5 or 10 years
when heart-lung transplants will be considered at least as common
as kidney transplants?
Dr. Shumway. I don't think so, no. I don't believe there will ever
be the incidence of transplantation of those organs that you see in
the kidneys, nor do I think there will be the need. It is possible, but
certainly not in the next decade.
Mr. Durbin. I am interested in that comment that there
wouldn't be the need. Could you expand on that a minute?
Dr. Shumway. Yes; for example, in cardiac work, the original
conditions that mandated the possibility of transplantation are now
being ameliorated by new operations that are being developed, dif-
ferent techniques, even occasionally we might get around to pre-
ventive medicine from the standpoint of coronary artery disease.
On the horizon, there is the use of the laser to melt away coronary
lesions. So, there are all kinds of developments that are, I think,
going ahead in that field that would tend to keep the incidence
somewhat lower than the kidney.
Mr. Durbin. Do you see it as advisable from a national viewpoint
that there be more centers in the near future that would consider
heart-lung transplantation as at least a procedure that they would
have people proficient to perform?
Dr. Shumway. Yes; I think so. As Dr. Starzl said, people are
being trained in these aspects of transplant and are now moving to
other medical centers around the country. So, there will certainly
be an increasing number of such cases performed.
Mr. Durbin. Does this particular procedure, the heart-lung trans-
plantation, call for a substantial investment in new equipment for
a hospital that would want to undertake the program?
Dr. Shumway. No; not at all.
As a matter of fact, as I tried to intimate in some of my earlier
remarks, the early results from heart-lung transplant patients
seem to us to be better than the results from heart transplantation
alone. There are many possible reasons for this, and some of them
are entirely speculative. But, nonetheless, it is an extremely inter-
esting era that I think will be explored much more fully in the
next few years.
Mr. Durbin. I want to commend the panel, too. I think you make
some very telling points on the economic aspects of this discussion.
I do not envy your job for 1 minute. I have been to Houston and
122
saw what Dr. Cooley faces every day with people waiting in the
room begging for the chance to be operated upon, and you have to
face that day in and day out. That human aspect is something that
I think is a burden that many of us don't appreciate until we have
been there.
But I would say that, from a governmental viewpoint, we are
coming down more and more to a question of it is your money or
your life. When it comes to health care and the expenditures of
money in light of some of our fiscal problems, I think that the
American people are saying quite clearly that they want good
health, they want the best medical techniques available, and I be-
lieve they are prepared to pay for it.
When we hear what you have said concerning the long-term sav-
ings, Dr. Starzl, the long-term savings of this type of approach, it
makes our job that much easier to concur with that belief that we
have got to have the best health care in this country available to
everyone.
Thank you all.
Dr. Shumway. One thing that should be pointed out is that, in
the world activity in health care, the United States is absolutely
preeminent. It may be falling behind in automobiles and various
other technologies, but in health we are way ahead. I think we
would certainly like to keep it that way.
Mr. Durbin. You bet. Thank you very much.
Mr. Gore. We certainly would.
Just following up briefly on my colleague's questions, 15 years
ago, an NIH task force estimated, Dr. Shumway, 12,000 to 32,000
heart transplants a year.
Dr. Shumway. That was absolutely ridiculous. I don't know how
they sat down and arrived at that figure, but it is quite preposter-
ous. That would be a situation perhaps when we would get around
to the point when we could use animal donors for transplantation
purposes. Those figures are phony.
Mr. Gore. You mentioned the subject of animal donors, the so-
called xenografts. You were quoted recently as saying that you be-
lieve that ought to be actively studied?
Dr. Shumway. It is, yes.
I think one point — and Dr. Starzl knows more about this because
of the renal xenografts that were used in Colorado in the early
days — but in New Orleans, for example, one chimpanzee kidney
survived for 10 months in a human recipient. What we are talking
about today in terms of homografting or allografting may be, in the
long view of the subject, just a step toward the availability of other
kinds of donors, namely xenografts. But there is quite a bit of work
going on in this area now.
Mr. Gore. In other words, partly because of the shortage of
human donors, you are actively exploring the possibility of trans-
planting animal hearts into patients.
Dr. Shumway. Yes, but it is still in the distant future. I wouldn't
want anybody to think that this is just around the corner. This is
really a developing area of research, even now.
Mr. Gore. I see.
Dr. Starzl. Also, there has been some understanding about the
nature of the animal donors that is a little bit disquieting since
123
those early days. I have had experience with baboon and chimpan-
zee heterografts, what you are calling xenografts. The baboon, I
think, is too far away from the human, although those kidneys did
function for about 2 months or maybe even a little longer than
that. But the rejection was very hard.
I think what Norm may be driving at is that there has been a lot
of awfully good information coming out about the effect of cyclo-
sporin in heterografts. It, of course, has improved the outlook
there as well.
But I was reminded that we, in a very serious emergency situa-
tion at one time, did a chimpanzee heterograft to a child whose
first human liver had failed, so we were really against the wall. We
got from the Air Force a chimpanzee that was 3 or 4 years old, and
the chimpanzee was brought to Denver in a cage and was brought
over to my house and had tea. It actually was able to have tea.
When it finished it made some human gestures, and so forth. It
was so human, it was uncanny. I was really uneasy about taking
that little chimpanzee's liver. I would never do it again. It is too
close to being human.
I saw a program not long ago on television about the origin of
man, and it made it pretty clear that the gestures and the facial
expressions and the powers of reasoning that chimps have are so
close to human. I would have a lot of trouble doing that again. But,
to me, that is the only animal right now that is close enough to the
human to hold a lot of promise of immediate application. It is prob-
ably a sentimental point of view anyway.
Mr. Gore. Just briefly, how do artificial organs play into this
problem? Is it safe for me to assume that the future utility of an
artificial heart is problematic, and the number of patients who will
benefit is probably sharply limited; and second, that it is highly un-
likely that we will see artificial kidneys or livers or pancreases or
lungs at any time in the foreseeable future?
Dr. Shumway. I think that is true. I think the recent experience
in Utah lasted much longer than anybody had anticipated. Certain-
ly, the kind of apparatus that is available now and was used there
is in no way similar to what you would expect the final artificial
heart development to be like. So, I personally, believe we will be
using xenografted tissue before we have the inexhaustible totally
implantable nonheat-producing kind of power source. It will prob-
ably be in our automobiles and refrigerators first, before artificial
hearts.
Mr. Gore. Congressman Reid, did you have any questions?
Mr. Reid. No, I don't, Mr. Chairman. Thank you.
Mr. Gore. Congresswoman Schneider?
Mrs. Schneider. I just wanted to follow up on some of the ques-
tioning a little earlier on cyclosporine. Where does it sit right now
with the Food and Drug Administration?
Dr. Starzl. They had a meeting over there on the 25, and they
asked me to give data for it because we had one of the studies. The
advisory board voted unanimously to move to whatever the next
step to general release is, to go forward with that. I don't really
know what the pathway is from that point onward, but certainly it
passed through that the first steps quickly.
124
Mrs. Schneider. Is there any reason that you presented or others
presented to the Food and Drug Administration as to why it
shouldn't be used?
Dr. Starzl. No; it was uniformly favorable testimony, I would
say.
Mrs. Schneider. OK. Thank you very much.
Mr. Gore. How close are we to offering any sort of hope to the
1.5 million diabetics who I am told would benefit from a pancreatic
transplantation procedure, Dr. Williams?
Dr. G. Melville Williams. I think this will probably be the next
organ to surface in a dramatic way in transplantation.
The problem with diabetes is that it is really quite different in
nature than the other diseases that we are talking about where
failure is equivalent to death. The pancreas can fail and a patient
can be sustained on insulin for a long period of time. So, the point
at which one intercedes is a point way down the line somewhere
after the complications have already developed.
So, this has, been one of the problems. Most of the diabetics who
have been transplanted so far have had concomitant kidney fail-
ure.
Mr. Gore. I see.
Dr. G. Melville Williams. When and if the results become well
known and if they continue to improve as they are, then it would
give us justification to intercede at an earlier time period. I think
it will, in the next 3 or 4 years, be a very important organ to trans-
plant.
Mr. Gore. Dr. Starzl?
Dr. Starzl. Probably the time is here now. We have done two
pancreas transplants over there in Pittsburgh. We didn't do it for a
long time because we were not satisfied that the technical aspects
of that operation had been worked out. But I am satisfied that that
is the case now. I think that we will go forward at a steady, al-
though not a panicky rate, with the pancreas.
There are a number of centers around the country that are all
doing good work. Minnesota has done more than any other center.
The University of Cincinnati is a good one. Some of the surveys
from these regional procurement groups— yours, for example-
showed quite a surprising number of pancreases being done.
I think the biggest deterrent to going forward with pancreas
transplants is the very one that Mel described, and that is that
there is a very sound alternative form of therapy. But in some pa-
tients, it doesn't work. Some people die from diabetes mellitus. On
the way to dying, they usually develop multiple organ failure, in-
cluding the kidney. So, perhaps it is appropriate— you sounded as if
you thought maybe that was being too restrictive— but I think it
may be appropriate to not even consider a pancreas until you have
bone fide evidence of failure of the second organ system, and that
would usually be the kidney or the eyes, impending blindness.
Do you want to comment on that?
Dr. G. Melville Williams. Yes; that is currently, I think, the ac-
cepted way. But I suspect that, when the results get better, the
demand will be made to transplant somebody with a creatinine of
2.2, as opposed to transplanting him when he is on dialysis.
125
Dr. Starzl. Then, there is really going to be a horrible crunch,
but I don't even want to think about that. I think that, in many
ways, the transplantation of the pancreas and the liver are, al-
though they are said to be compatible, basically incompatible pro-
cedures using the same donor.
Mr. Gore. We are talking then in descending order of how
common they are, the kidney transplants, liver transplants, heart
transplants, heart-lung transplants and pancreas transplants. The
only other item on the agenda would be corneas; is that right?
Dr. Starzl. No; the intestine is coming up also.
Mr. Gore. The intestine is coming up also.
Dr. Starzl. Yes, sir, it had never been possible, although many
people tried over two decades, to obtain chronic survival in dogs
after intestinal transplantation. Suddenly, it became possible. A
group up in London Ontario did it and we did it. We have two dogs
that are 600 or 700 days after complete midgut, complete intesti-
nal, transplantation. They look completely normal. So, I think that
is another area that will be explored.
Here, I think that, at least until it really gets worked out, I
would call that an experimental procedure.
Mr. Gore. I see. And then, of course, bone marrow transplants
are in a slightly different category because it is renewable?
Dr. Starzl. Yes; that is no longer experimental. That is a spec-
tacular story of its own.
Mr. Gore. Yes.
How are the two pancreas transplants doing?
Dr. Starzl. They are doing fine. They are former diabetics.
Mr. Gore. Let me thank you again for coming and for honoring
us with your presence. You gentlemen are heroes in America for
the lives you save, for the work you do, and we can't thank you
enough for taking time out of your very important activities to
share with us in an effort to try to develop a national strategy for
what is surely going to be a dramatic upsurge in the need to obtain
organs and to deal with the surrounding problems in a more
rational and effective way. Thank you very much.
Dr. Starzl. Thank you.
Mr. Gore. Our final panel today is made up of Mr. Donald W.
Denny, director of organ procurement, Transplantation Office in
the University of Pittsburgh School of Medicine in Pittsburgh; Ray-
mond Coleman, founding president of Donor Alert, Warwick, R.I.;
and William W. Pfaff, M.D., past president of South-East Organ
Procurement Foundation at the University of Florida College of
Medicine in Gainesville, Fla.
We will begin with you, Donald W. Denny, director of organ pro-
curement, Transplantation Office, University of Pittsburgh School
of Medicine. Welcome.
Without objection, your entire text will be included in the record,
and we invite you to proceed with your presentation.
23-029 0-83
126
STATEMENTS OF DONALD W. DENNY, DIRECTOR OF ORGAN PRO-
CUREMENT, TRANSPLANTATION OFFICE, UNIVERSITY OF
PITTSBURGH SCHOOL OF MEDICINE, PITTSBURGH, PA.; WIL-
LIAM W. PFAFF, M.D., PAST PRESIDENT, SOUTH-EAST ORGAN
PROCUREMENT FOUNDATION, UNIVERSITY OF FLORIDA COL-
LEGE OF MEDICINE, DEPARTMENT OF SURGERY, GAINES-
VILLE, FLA.; AND RAYMOND COLEMAN, FOUNDING PRESIDENT,
DONOR ALERT, WARWICK, R.I.
Mr. Denny. Mr. Chairman, members of the subcommittee, I
thank you for conducting these hearings today. The subject of
organ procurement and distribution for transplantation is of na-
tional concern.
Despite the headlines that you perhaps have seen, and despite
some of the comments that I have heard here today, I would like to
indicate at the outset that I believe there is in effect today in this
country an effective system for the procurement of vital organs for
transplantation. It is not a random process.
The process is not an easy one. The system is not a perfect one.
We have heard that there are this year approximately 2,500 post-
mortem organ donors, but yet all studies indicate that this is any-
where from one-tenth to one-third of the potential donors from
whom organs could be recovered.
The recovery of organs for transplantation is a three-tier process.
In trying to understand where the problems lie behind the short-
age of organs, behind the fact that we are now recovering so few of
the organs from all of the potential donors, I would like very brief-
ly to outline this three-tier process. The three tiers are, in short,
the organ procurement programs in this Nation; the physicians
and nurses at the acute care hospitals in the United States; and
third, all of us, the general public, those of us who inevitably will
die, those of us who will succumb at one time or another, and who
couid be potential vital organ donors.
The first tier, the organ procurement programs in this country:
There is a nationwide regionalized system for the recovery of
organs for transplantation. There are in the United States approxi-
mately 110 organ procurement programs. These 110 programs have
been established over the past several years primarily to serve the
need for the recovery of kidneys for transplantation. In recent
years with the development of extra-renal — that is, organs other
than kidneys — transplantation, these 110 organ procurement pro-
grams have been challenged to recover hearts, livers, heart-lungs,
pancreas, and so forth, as well as kidneys from their donors.
The 110 organ procurement programs in this country today are,
in large part, run by and made effective by the organ procurement
professionals, nonphysicians like myself, most of whom belong to a
nationwide association of coordinators, the North American Trans-
plant Coordinators Organization. Over 360 of us in this country
labor to provide organ donation education of physicians and nurses,
as well as the public. We are also available generally to receive the
referrals of donors, to evaluate donors, and to assist on the scene in
donor hospitals in making possible the necessary clinical, medicole-
gal, and psychological adjustments which are necessary to recover
the organs for transplantation.
127
The 110 organ procurement programs and their associated organ
procurement coordinators struggle to provide professional educa-
tion, to doctors and nurses especially. In my area, I speak over 120
times a year to medical staffs in acute care hospitals, to critical
care nurses in intensive care units and emergency rooms, trying to
help them understand the importance of recovering organs for
transplantation, conveying to them who donors are, helping them
understand how to manage these donors so that vital organ func-
tion can be sustained, helping them understand the psychology of
the donation process in dealing with grieving families.
But it is not just a matter of information giving, unfortunately.
We are all besieged by sources of information. We are all besieged
by demands to pay attention to urgent needs. Maybe this is espe-
cially true of physicians and nurses.
Information giving is frequently not enough— helping a doctor
understand that there is a need for organs, who donors may be and
what the process is. Sometimes the challenge is to excite them, to
make them feel it as we feel it. And sometimes we despair because
we are unable, through information giving or through challenging
their feelings of caring for dying patients, we are unable to secure
their cooperation.
The dissemination of information to physicians and nurses car-
ried out by the 110 organ procurement programs in this country
has been spotty in some areas. We have received referrals of
donors and calls from physicians as far away as the west coast who
have called Pittsburgh to ask who donors are, what should they do
because they think they have a donor in the hospital, and they are
unaware of their own local organ procurement programs. I don't
mean to fault the organ procurement programs in these other
areas of the country. It is a tremendous job to try to educate and
sustain interest among physicians and nurses in organ donation
when their primary concern is caring for living patients, patients
who are ill of other diseases.
Because of the apparent lack of a uniform method to educate
physicians and nurses in this country today, because of the appar-
ent holes in our educational system, the North American Trans-
plant Coordinators Organization recently established a 24-hour in-
formation and referral service for doctors and nurses throughout
the country. An 800 number, so it is a toll-free call, is available to
physicians and nurses anywhere in the Nation who are not aware
of who donors may be or who do not know how to contact their
own local procurement program. This 800 number is a mnemonic
number that is easy to remember, 800-24-DONOR. You pick up
the phone and dial 800-24-DONOR.
Mr. Gore. How recently was this established?
Mr. Denny. This was established 10 days ago.
Our struggle now is to acquaint physicians and nurses through-
out the country with the availability of this number. Let me stress
that this 800 number is not meant to supplant the 24-hour referral
nu.m^rs in Place at the 110 organ procurement programs. Instead,
this 800 number is meant to supplement it, to provide information
for a doctor who does not who to call in his own area and, believe
me, there are many of them.
128
The organ procurement programs, going further into my brief
look at this three-tier process, also, in addition to providing educa-
tion, provide the manpower and the technology for the recovery of
organs for transplantation. Surgeons, physicians, and paraprofes-
sionals like myself are available 24 hours a day, around the clock,
throughout this country, to recover vital organs for transplanta-
tion. We don't lack the skill, we don't lack the manpower, we don't
lack the technology to recover organs for transplant. Every organ
procurement program has as one of its major goals the recovery of
kidney ior transplantation for the nearly 6,000 people who are
now waiting for renal transplantation in this country.
Additionally, however, the organ procurement programs collabo-
rate to a great degree in the recovery of extra-renal, nonkidney,
organs for transplantation. Cooperation between these 110 organ
procurement programs has developed dramatically over the past 2
years. Witness the fact that the University of Pittsburgh, which
has a very large waiting list for liver and heart transplant pa-
tients, now works collaboratively with other organ procurement
programs around the country in recovering two-thirds of the livers
that we transplant and three-fourths of the hearts that we trans-
plant. In other words, our own area, within 140 miles of Pitts-
burgh, which is the geographic region that our organ procurement
programs covers directly, isn't sufficient to provide the organs for
transplantation that we need, especially in the area of livers and
hearts.
Through the collaboration of other organ procurement programs,
we have flown as far west as Oklahoma City and Fargo, N. Dak.,
and as far south as Houston and Miami to recover organs for trans-
plantation through the good efforts of organ procurement profes-
sionals in those area.
Yet, I have to admit before this committee this morning that, al-
though we have collaborated with almost 50 of the 110 organ pro-
curement programs in this Nation recovering extra-renal organs,
there are still many of these programs that do not call us when
they have kidney donors, and do not give us an opportunity to re-
cover livers or hearts from their donors.
The system is developing. One of the reasons that we don't re-
ceive collaboration from all of the organ procurement programs is
that they are in need also of education. They need also to under-
stand that working with us in recovering hearts and livers is not
going to compromise their kidneys which they need desperately for
transplantation locally.
In addition to organ procurement education, and procurement
services, organ procurement programs are actively involved in the
distribution of organs for transplantation. In the case of kidneys—
you shall hear from Dr. Pfaff in a few minutes— there is a comput-
er system which is an excellent means of locating suitable recipi-
ents nationwide for transplantation of kidneys. When we have kid-
neys available in the Pittsburgh area that we are unable to trans-
plant among our patients, the computer will print out for us a list
of suitably matched recipients throughout the country.
The computer system has limtitations, however. In the distribu-
tion of extra-renal organs, a somewhat different system has been
utilized to supplement it. The computer is a fixed-base operation. A
129
terminal is located in my office, but there is no terminal in the
community hospital where I may have a donor. What do I do at 2
o'clock in the morning when a donor is identified in a community
hospital 100 miles from Pittsburgh and I am preparing to sit down
and talk with the grieving family to suggest that they donate
organs? I need to know immediately where a suitable recipient for
the heart or liver may be. In the case of kidneys, we can wait until
the organs have been removed and access the terminal when we
get back after the donor surgery. In the case of hearts and livers,
we need to know where the recipients are before we remove the
organs because of the very limited preservation times that we have
for these organs.
I can't access a terminal at 2 o'clock in the morning from 100
miles away from my office. Instead, what we have now is a 24-hour
telephone system, also established by the North American Trans-
plant Coordinators Organization, a telephone system which is con-
trived to provide information concerning the needs for hearts,
livers, heart-lungs, and other extra-renal organs to organ procure-
ment professionals around the country. Twenty-four hours a day, if
we access a central telephone number, we are informed through a
recorded message of what organs are needed from Stanford, Calif.,
to Pittsburgh, from New York City to Virginia to Memphis, Tenn.
Fifteen extra-renal transplant centers now cooperate and list
their extra-renal organ donor needs on this 24- Alert System. The
calling coordinator or physician will be told the blood type, the size
of the donor that is sought, the distance that the transplant center
is willing to fly, the telephone number to call if a donor is availa-
ble. The caller is also informed of the potential recipient's medical
condition, that is, the degree of urgency for transplantation.
Brandon Hall today is flying back to Memphis for his liver trans-
plant. This liver transplant was made possible by the fact that the
organ procurement coordinator in Virginia who recognized the
donor called the 24-Alert telephone number and was informed
through this service that the University of Tennessee, had an
urgent need for a pediatric donor liver of a given size and blood
type for Brandon Hall. He copied down the phone number and
gave them a call.
This system doesn't sound very sophisticated. Computers sound
so much more high-tech, don't they, than phones and recorded an-
swering services? But this system works. It is effective. It is availa-
ble to all of us, and it has made possible in the last 6 months the
transplantation of 48 livers at 5 centers, and 25 hearts at 9 centers.
Going on briefly in my description of the three-tier system, the
second tier are the health professionals, the doctors and the nurses
in this country, who are in a position to recognize suitable donors
to provide the organs for transplantation.
I have been an organ procurement professional for the past 9
years. I am glad to say that the physicians and nurses in this coun-
try, by and large, support organ donation. Unfortunately, however,
verbal support isn't sufficient. We also have to have their active
support. Unfortunately also, it is accurate to say that many physi-
cians and nurses do not collaborate with us in recovering organs
for transplantation.
130
Ignorance, apathy, indifference, they all play a part. But perhaps
the biggest problem is the medicolegal problem— physicians and
nurses who fear that if they cooperate in the recovery of organs for
transplantation, they will be vulnerable to litigation. We live in a
litigious society, and physicians especially know how damaging nui-
sance lawsuits can be. As a result, they oftentimes practice defen-
sively. Their patients are not waiting for transplants, and our re-
quests that they help us sometimes fall on deaf ears because of
their fear of medicolegal vulnerability.
Brain death is a central issue related to organ donation. You
can't escape it. By definition, all donors are victims of brain death.
They are medically and legally dead because their brains are dead.
They are no longer thinking, feeling, willing, reflexive people. Arti-
ficially their hearts and their respiratory systems continue to func-
tion, and this is what allows the viability of the organs to be pre-
served until they are removed and chilled.
Physicians are especially concerned about the public's acceptance
of brain death. Thirty-five States now have passed statutes recog-
nizing that brain death is death. Fifteen States do not have laws
defining brain death, but in those 15 States, common law or apel-
late court decisions allow the recovery of organs for transplanta-
tion following pronouncement of death on the basis of brain death.
But despite legal support, doctors and nurses often fear that the
public does not accept brain death and do not cooperate with us.
Less than 1 percent of all the deaths that occur in this country
occur under the circumstances of brain death and among the popu-
lation that is within the right age frame to be a donor.
In my mind, the health professionals, the doctors, and the nurses
in this country, are the weak link between the first tier, the organ
procurement programs, and the third tier, the lay public. In my ex-
perience in the Pittsburgh area and in Pennsylvania generally, ap-
proximately one out of five families says no to organ donation; but
four out of five families who are approached and offered the oppor-
tunity, say yes. These figures are not duplicated in many other
areas of the country, however. As you have heard today, cultural,
racial, and educational factors influence whether or not members
of the public will say yes to organ donation at the time of death.
The American public, however, does have a big heart. One of the
gratifying aspects of my job is that I deal with these grieving fami-
lies and see firsthand the value that it provides the grieving family
to be told that the organs from their loved one now sustain life in
two, three, four, or five other patients.
In my experience, only 1 out of 10 families of a brain dead victim
initiates the request to donate. Most families at the time of death
are too overcome with their own grief to remember the need for
organs. I am not concerned by the fact that the national Kidney
Foundation poll recently found that only 40 percent of the white
population and 20 percent of the black population would be willing
to donate organs of their loved ones at the time of death. We don't
want to believe that we are going to die. We don't want to believe
that our loved ones are going to die. As a result, when we are
asked— not at the time of death, but at the time of life— whether or
not we would donate, of course, we say no. It is too scary to even
consider that these people might die. At the time of death, as I
131
said, only 1 out of 10 families initiates the request to donate. But 8
of those 10 families, in my experience, do donate if they are offered
the opportunity.
The problem comes, again, at the medical professional level, the
need for physicians and nurses to adequately explain brain death
to the families and to offer donation. It is so difficult sometimes for
doctors and nurses who, themselves, grieve when they lose a pa-
tient to sit down and try to explain to a family that their loved one
in the intensive care unit is dead. It is especially difficult because
this patient does not look dead. He is, remember, a victim of brain
death. Artificially, his heart and his lungs are continuing to func-
tion.
To try to explain to a family that this brain-dead victim who
looks as though he is alive and merely comatose is really dead is a
difficult for a physicians, and sometimes they shirk it. Sometimes
they shirk it because of their own grief, their own pain, the assault
on their integrity which they are experiencing because of the
death. Sometimes it is so much easier for a physician to distance
himself from the family.
The American public is hungry for information about organ do-
nation. Thousands and thousands of donor cards are distributed by
our program and other programs around the country, but it is not
enough. We need more public education, not only with regard to
organ donation, but with regard to brain death as well. It is time
that we stopped hiding brain death and talked about it openly. It is
time the medical profession talked about it openly.
Public education in the past has been primarily aimed at the
people who already are convinced that organ donation is a good
thing. Public education is largely directed toward white middle-
class America. We need public educational efforts which are direct-
ed toward population subgroups, Spanish Americans, black Ameri-
cans, Americans from the Mediterranean Basin, and so on. These
groups do not donate with the same high frequency as the white
middle-class public does.
Physicians and nurses are consumers of the media, and they gen-
erally follow and do not lead public opinion. If we educate the
public, we will also indeed be educating the medical professionals.
If they feel that the public is comfortable with brain death and
with organ donation, they will be much more likely to collaborate
with us.
I have five recommendations. First of all, it is time that the
transplant professionals in this country recognize that they can't
do the job alone. There is a need for a national task force to be
composed of leaders from government, medicine, organ procure-
ment, and interested lay groups to tackle the problems impeding
the recovery of organs for transplantation. It is time that the trans-
plant professionals in this country recognize that they need to in-
volve their colleagues in the medical profession. The neurosur-
geons, the neurologists, the critical care medicine physicians, the
emergency physicians, the pediatricians should be members of such
a task force. They are the physicians who will recognize donors.
They are the people who need to be convinced that it is important
to work with us.
132
The critical care nurses are by far our most vital ally. They, too,
should be involved in a national task force. This task force should
be given the charge of coming up with solutions for developing and
improving the system nationwide.
My second recommendation derives from the fact that every hos-
pital in this country must be certified to function, must be certified
on several levels. Departments of health in the various States have
the responsibility of certifying hospitals in their States. The Joint
Commission for the Accreditation of Hospitals also provides ac-
creditation of hospitals on a national level.
There should be developed for accreditation two requirements
either on the State or on the national level. The first requirement
should be that there be a policy and an operational protocol for the
determination of brain death. Second, there should be a require-
ment for certification that every hospital establish a policy and a
protocol for recognizing potential donors and referring donors for
the nearest organ procurement program.
Doctors refer donors. Hospitals don't refer donors, but if the hos-
pitals have the rules and the regulations, the doctors may be made
more willing to comply, to cooperate.
My third recommendation: there should be a financial incentive
program established by the Health Care Finance Administration,
which has the responsibility of funding kidney transplantation. A
financial incentive would reward hospitals at which donors are
identified and from whom organs are recovered.
It is well known that kidney transplantation is much more cost
effective than is hemodialysis or peritoneal dialysis for the treat-
ment of end-stage renal failure patients.
This country, and you and I as taxpayers, have an incentive in
seeing more people transplanted, if only because it costs less. It
makes good sense to me to recommend that the Health Care Fi-
nance Administration provide a financial incentive to those hospi-
tals from which kidneys are recovered.
Since almost every postmortem kidney donor is also a potential
postmortem extra-renal donor, this will increase the number of
extra-renal organs available.
My fourth recommendation is that there is a need for strength-
ening public and professional education. Public education has been
tried in many forms on the local level, for example, health fairs,
talks to school groups. These kinds of local educational efforts, to
my mind, are not effective.
What is effective is use of the national media, not only to provide
information about donation and brain death, but to excite people.
We have to inform, but we have to motivate, as well. We have to
touch their feelings.
There is much more work that we could do in public education. I
would like to see the American Advertising Council take on a cam-
paign in this country to help educate Americans about organ dona-
tion.
Finally, there is a need for statistical information. As we have
heard today, we have to talk in general figures, because nobody
really knows how many potential donors there are in this country,
for instance.
133
Nobody really knows how many potential donors are referred.
Nobody really knows how many end-stage renal disease patients
there are in this country.
Nobody really knows how many potential recipients of extra-
renal organs there are. One vital question, I think, needs to be ad-
dressed, and that is how many potential pediatric donors are there
between the ages of 6 months and 5 years?
The need for pediatric liver donors between six months and five
is tremendous. We have a waiting list of over 35 children in this
age bracket who are waiting for liver transplants.
I know, we all know that many of them will die because we will
not find organs for them. We may be faced with the fact that there
are not enough potential pediatric donors in the Nation to meet
the needs of all of these youngsters.
Again, let me congratulate this subcommittee, Chairman Gore,
members of the subcommittee, for your interest, for your efforts in
spotlighting the accomplishments and the problems and the goals
that we strive for as the future unfolds for us in what is a very
promising time for transplantation. Thank you.
[The prepared statement of Mr. Donald W. Denny follows:]
134
TESTIMONY ON
ORGAN PROCUREMENT AND DISTRIBUTION
FOR TRANSPLANTATION
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
APRIL 13, 1983
DONALD W. DENNY
DIRECTOR OF ORGAN PROCUREMENT
TRANSPLANT FOUNDATION
UNIVERSITY OF PITTSBURGH
135
Testimony of DONALD W. DENNY p.1
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science" and Technology •
U.S. House of Representatives
April 13, 1983
My name is Donald W. Denny. I am the Director of Organ
Procurement for the Transplant Foundation at the University of
Pittsburgh. I am also a member of the North American Trans-
plant Coordinators Organization (NATCO), a professional assoc-
iation of transplant and organ procurement coordinators from
the United States, Canada and several foreign countries. My
testimony today will primarily reflect my personal experience,
attitudes and values. I am also designated as the official
representative of NATCO at these hearings, but when expressing
the point of view of this association of over 350 transplant
professionals, the context of my remarks will identify my
position as a spokesman.
I wish to express my appreciation to the Chairman and
members of this Subcommittee for conducting these hearings into
the subject of post mortem vital organ procurement and dis-
tribution for transplantation. I have been closely involved. in
organ procurement for the past nine years, have participated in
the organization of and have administered two organ procurement
programs. I believe that the subject of these hearings is a
health care crisis, which requires broad national attention and
the problem-solving efforts of individuals, organizations and
government .
Recent advances in transplantation surgery and immunology
now provide the opportunity for additional years of life and health
to many Americans who in the past were doomed to an existence
supported by a machine, as in the case of victims of end-stage
kidney disease, or were cut down by death prematurely, as in
the case of people suffering from end-stage heart and liver
disease. Other witnesses before this Subcommittee will provide
substantive information to support my contention that medical
136
Testimony of DONALD W. DENNY p. 2
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology -
U.S. House of Representatives
April 13, 1983
science has moved beyond the frontier in organ transplantation,
has, indeed, reached a fertile high ground and needs but the
active support and investment of this nation to establish a
living monument to the value of human life and the spirit of
brotherhood: the giving of life, one to another, on a large
scale through organ transplantation. My focus today will be
with one obstacle impeding realization of this bright promise:
the shortage of human organs for transplantation that exists
now and, unless nationwide efforts are undertaken, will in-
crease tomorrow.
The shortage of organs for transplantation is not a new
problem. My colleagues and I have worked for years to overcome
the fact that the demand for post mortem kidneys has long ex-
ceeded the supply. The number of post mortem kidneys trans-
planted in the United States has remained relatively stable for
several ' years , despite the fact that the national waiting list
has continued to grow annually. The shortage of kidneys for
transplantation has received relatively little attention,
largely because renal transplantation is not a form of trans-
plant therapy which is often an alternative to death. We have,
fortunately, the artificial kidney machine which can sustain
life for most end-stage renal disease (ESRD) patients who elect
to wait for a transplant, as well as those patients who do not
wish to consider or are unsuitable for transplantation. The
undeniable facts that a real kidney, a transplanted kidney,
provides a better quality of life for ESRD patients and that
renal transplantation is more cost-effective per patient
life-year than the artificial kidney have not been sufficient
137
Testimony of DONALD W. DENNY p. 3
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Techno-logy -
U.S. House of Representatives
April 13, 1983
to cause the national sense of urgency which underlies these
hearings. Without intending to diminish the meaning and the
importance of this Subcommittee's purpose today, I must lament,
however, the fact that recent publicity concerning the need for a
liver transplant for a handful of patients at two or three trans-
plant centers (including my own) has outweighed the silent
suffering of many thousands of patients waiting for a kidney
transplant at 150 transplant hospitals over the past decade in
moving the conscience of this nation.
Yet, it is undeniable that liver and heart transplant can-
didates, unlike kidney transplant patients, have only one other
option: death. I cannot blame the media or the public for being
more profoundly stirred by a picture of one sad-eyed dying child
waiting and hoping for a liver donor than by cold statistics which
represent the plight of faceless thousands of ESRD patients. We who
spend our professional lives seeking donors of extrarenal organs
(i.e., organs other than kidneys) have also been vulnerable to the
poignancy of the individual child's desperate need. And when such
a patient dies because an organ is not found in time, we also feel
a crushing sense of sadness and failure. But we also feel
something else, something the public generally does not, namely
frustration and anger. The reason is that we know that many more
organs are needlessly wasted than are recovered for transplan-
tation. We know that the shortage of organs at this time is not
due to a lack of technology, manpower, knowledge or funding, as
much as it is due to ignorance, inertia, selfishness and parochialism.
138
Testimony of DONALD W. DENNY p. H
Hearings on Organ Procurement and Distribution
Investigations and" Oversight Subeommi-ttee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
We know, in short, that despite what one reads in the newspaper,
there is a system in place in this country for the recovery of
organs for transplantation, but that this system does not work as
effectively as possible because of the lack of individual and
institutional committment to the recovery of organs for trans-
plantation .
From February, 1981, through February, 1983, 126 post mortem
livers were transplanted at the University Health Center of Pitts-
burgh. During this same period, 44 adults and 27 children died
before we found a suitable organ for them. During this same in-
terval, 41 patients received heart transplants at our Center, but
8 other patients succumbed to heart failure before we could trans-
plant them. The success of liver and heart transplantation today
is encouraging many more institutions to establish programs for
the transplantation of these organs in order to meet the needs of
increasing numbers of potential recipients. The problem promises
to become worse.
I need to define some limitations in order to express fully
the nature of the problem. The post mortem recovery of vital or-
gans for transplantation is limited by the circumstances of death,
donor age, donor medical history, quality of organ function and
temporal restrictions. Because vital organs are very vulnerable
to lack of oxygenated blood at normal body temperature, we are
unable to consider as donors of vital organs any individual whose
death is determined by the traditional criteria, i.e., irrever-
sible cessation of heart and lung functions. Organ death occurs
within minutes of cessation of the circulation. Vital organ
139
Testimony of DONALD W. DENNY p. 5
Hearings on Organ Procurement and Distribution
Investigations and- Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
procurement is limited to patients who are medically and legally
dead, but whose heart and lung functions are artificially main-
tained with mechanical ventilation and intravenous hydration until
the organs are surgically removed and chilled. In practice this
means that organ donors must be victims of brain death, i.e.,
patients who have suffered catastrophic, irreversible and complete
cessation of integrated brain function as the result of trauma,
stroke, brain tumor and/or oxygen deprivation. The brain death
syndrome by definition always includes destruction of brain stem
function, among the sequelae of which is the total inability to
breath spontaneously. Forty years ago before the development of
the mechanical ventilator, which is used to take over respiratory
functions for patients who have difficulty breathing or cannot
breath spontaneously, death of the brain resulted in cessation of
breathing and, secondarily, heart failure when the heart muscle
died due to lack of oxygen. Use of the mechanical ventilator" has
intruded upon this natural sequence of events and physicians have
had to develop new operational criteria for determining when death
has occurred in patients suffering from total and irreparable
brain destruction. Pronouncement of death after determination of
brain death is a commonplace event in the United States and is
sanctioned by either statute or common law in all 50 states. Organ
donation is not the primary or even secondary rationale for accep-
ting brain death as death of the individual, but it is a necessary
precondition for organ retrieval for transplantation.
140
Testimony of DONALD W. DENNY p. 6
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
Another limitation to donation is donor age. The inevitable
consequences of aging, including vascular disease and the slow
loss of optimum organ function, limits chronological age accep-
table for donors. Kidneys are generally accepted from donors
up to their mid-50's and sometime beyond. Liver donors are
rarely considered beyond age 45; while heart donors are carefully
evaluated if they are 35 and are seldom accepted beyond 40.
Minimum age limits are also a factor. Kidney donors must gener-
ally be one year or older. Liver donors can be accepted from
age 6 months and up, however. Heart donors are seldom less than
age 15.
Other factors which can contraindicate organ donation
include: previous disease involving the organ considered for
donation, infection, cancer (except primary brain tumors) and
acute injury to the organs due to trauma, oxygen depri-vation
and persistent periods of low blood pressure.
How many patients in this country's hospitals are victims
of brain death and have suitable organs for transplantation?
Again, no one really knows. Retrospective studies of hospital
charts of patients dying in hospitals suggest between 0.77? and
3-5? of hospitalized patients are acceptable as kidney donors
(1, 2, 3). The difference in the conclusions is due to variations
in acceptable criteria between investigators. (The percentage
of potential donors in these studies which actually did provide
organs for transplantation ranged from 17.0% to 19-03? (2, 3)-
Since only patients who die in hospitals may be considered
for vital organ donation, it is important to consider that only
38$ to 60? of the deaths in this country occur in hospitals
141
Testimony of DONALD W. DENNY p. 7
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
(1, 2, 3). Assuming that half of the annual deaths in the United
States occur in hospitals (which may be generous, since statistics
on hospital deaths include patients who are dead on arrival and
who expire in the Emergency Department soon after arrival), how
many in-hospital deaths occur? In 1981, the last year for which
statistics are available, there were a total of 1,987,512 deaths
in this country (4), of which 50% is 993,756. Multiplying this
figure by the above cited percentages of in-hospital deaths which
would have been acceptable kidney donors, yields an estimated
range of potential donors in the United States of 7,652 to 34,781.
Because the age criteria for liver and heart donors is less liberal
than for kidney donors, the potential number of extrarenal donors
is undoubtedly fewer than is indicated by this range.
How many donors annually yield vital organs for transplantation
in the United States? One way of determining an approximation is
by looking at the number of post mortem kidney transplants yearly.
In 1981, the last year for which I have firm figures, there were
3,^27 post mortem kidneys transplanted in this country. Since each
donor yields two kidneys, dividing this number by two results in
a figure of 1,713 donors. However, since there is approximately
25? wastage of donor kidneys (as a result of surgical error, un-
expected anomalies, no suitably matched recipients available), the
total number of available kidneys during 1981 was approximately
4,283, of which one-half or 2,141, represents the approximate num-
ber of donors in that year. In other words, we are now recovering
organs, at best, from fewer than one out of every three possible
donors .
23-029 0-83-10
142
Testimony of DONALD W. DENNY
Hearings on Organ Procurement and Distribution
Investigations and - Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
This figure does not represent the total number of potential
donors referred to organ procurement programs. Organ donation is
a voluntary activity in this country requiring consent of the
nearest next-of-kin (a practical necessity for all organ procure-
ment programs even when a donor has signed a donor card or other
document allowing recovery of organs after death). Organ donation
is unacceptable to some families and a percentage of prospective
donors is lost for this reason. My experience is that approximately
one out of five prospective donors referred to us does not yield
organs for want of family consent. This figure varies around the
country according to cultural, racial and educational character-
istics of the population. Black families, for instance, are much
less likely to donate than white families for reasons which are
not understood. The number of families which elect not to donate
is, however, somewhat larger, since an unknown number 'of potential
donors are recognized by physicians, who approach the families and
are refused, and never inform the local organ procurement program
of their efforts.
I value the fact that organ donation in this country is a
voluntary, altruistic act determined by the values of the people
concerned. National polls have indicated, however, that 70% and
more of the people in this country regard organ donation favorably
and would be willing to donate a family member's organs at the
time of death (5, 6). I would be against legislation which would
make donation either compulsory or subject to financial reward.
Another option exists, one which is in practice in a few European
countries, which is to assume that consent of the individual has
been given for post mortem organ donation at the time of his
143
Testimony of DONALD W. DENNY p. 9
Hearings on Organ Procurement and Distribution
Investigations and- Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
death unless a document signed by the individual indicating
opposition to donation is presented when he expires. Given the
litigious climate of this country and the vulnerabli li ty of the
medical profession in particular to nuisance suits, I doubt that
this option is realistic. Even if such a system were legal, I am
sure that surviving next-of-kin would also be asked to consent to
recovery of the organs, even as they are now.
Obviously, one means of increasing the numbers of organs
donated would be to enhance the willingness of families to donate
through educational programs. Educational efforts directed at
the lay public have been an important component of many organ
procurement programs' efforts for the past decade. Many approaches
have been tried: professional advertising techniques (billboards,
radio and television public service announcements, ads in newspapers
and magazines), didactic presentations to students, churches and
service clubs and news and feature stories released to the print
and electronics media. While I am sure that these efforts have
had an impact (some more than others), I am unaware of any reliable
studies which can document the effectiveness of public education
efforts tried thus far. I am personally biased in favor of the
effectiveness of the free educational opportunities afforded by
the media, although I have tried all the options cited above at
one time or another. News and feature stories focusing on people
with whom the public can identify reach the largest audience,
have more emotional impact and require less financial investment
than costly billboards, public service announcements, health fairs
in shopping centers or classroom talks. Stories about patients
144
Testimony of DONALD W. DENNY p. 10
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
waiting for transplantation, about patients who have been success-
fully transplanted, about individual donors and their families'
feelings regarding donation have great human appeal. The media
becomes quickly jaded, however, and one must constantly seek
new "angles" with which to interest the press.
Until recently, kidney donation and transplantation have
been the primary thrust of public education for most procure-
ment programs. One indication of the effectiveness of these
efforts is the greater frequency with which the public is will-
ing to donate kidneys as opposed to livers and hearts. The
heart, of course, is a special case in view of the great
symbolic and emotional investment traditionally associated with
this simplest of all the vital organs. On the other hand, very
little emotional attachment to the liver exists for most of us,
and yet many families who are very willing to donate their
family member's kidneys balk at donating the liver. The reason,
I believe, is that liver donation and transplantation are not
yet as well known and accepted as kidney transplantation.
Most public education efforts in some way try to go beyond
mere information giving and try to involve the audience in
solving the problem by encouraging the completion and carrying
of universal organ donor cards. Legislation has been enacted
in all fifty states making such cards legal instruments for the
post mortem donation of organs. As I have mentioned, however,
all organ procurement programs with which I am familiar also
require family consent, although legally it is not required if
a donor card is available. The success of organ donor cards in
145
Testimony of DONALD W. DENNY
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science" and Technology •
U.S. House of Representatives
April 13, 1983
p. 11
increasing the number of donor organs is minimal; relatively
few donors each year are identified as card carrying donors.
Our program has only one or two such donors each year out of 50
to 60 donors in our region. The primary problem, I believe, is
that our death is a very fearful prospect for most of us. We
defend ourselves against this fear by avoiding any activity
which tends to confirm our mortality. Completing and signing a
donor card affirms our appointment with death and, as a result,
most of us never get around to getting or completing a card.
Like most other organ procurement programs, we distribute donor
cards as many on 10,000 a year. This is not a large number
compared to our region's population of approximately 3.5 million
people, however. In Pennsylvania we have also had donor cards
distributed with drivers' licenses for several years, yet our
program has not seen an increase in card carrying donors as a
result of this program. A recent survey in Maryland, where. the
donor card is on the drivers' licenses, found that only 1.5% of
the people chose to complete and sign the card (5).
Organ donor cards do have some utility. Their availability
stimulates discussion and contributes to a positive climate of
awareness regarding the need for organs. Many times I have
been told by donor families that receipt of a donor card with a
driver's license engendered a family conversation, during which
the deceased indicated his willingness to be a donor. These
discussions are remembered at the time of death if organ donation
is offered to the family, even though the deceased did not fill
out the card. These families inevitably donate.
146
Testimony of DONALD W. DENNY p. 12
Hearings on Organ Procurement and Distribution
Investigations and- Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
I have always believed that public education should include
the subject of brain death, as well as organ donation and trans-
plantation. Many of my colleagues do not agree with me, believ-
ing that the subject is too complex for the lay public to compre-
hend or that there is a danger of brain death being misconstrued
as so-called "transplant death". This latter possibility exists
primarily because of the medical profession's hesitancy in edu-
cating the public about brain death, a syndrome which is undoub-
tedly clinically associated with many more non-donors than
donors. If brain death is mentioned only in conjunction with
organ donation, so the argument goes, the public will believe
the syndrome is diagnostic of death only when the organs are
sought, that brain death is not "real" death but a shortcut
designed to make organ recovery possible.
On the contrary, I find the public intuitively sophisticated
and ready to comprehend that death of the brain is diagnostic"
of death of the person if they are given accurate information
and the discussion is in lay terms which they can comprehend.
Not being candid about brain death and its relationship to
organ donation is potentially very dangerous. If the public
does not understand and accept it, they are much more likely to
experience suspicion and disbelief when they are faced with it.
We are all more ready to reject what we have not heard of or do
not understand.
Our emphasis on brain death education led us to seek enactment
of legislation giving statutory recognition to brain death.
Such legislation was not necessary to give legal standing to
the syndrome as diagnostic of death, but was perceived as a
means of educating the public. Public acceptance and passage of
147
Testimony of DONALD W. DENNY p.13
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science "and Technology •
U.S. House of Representatives
April 13, 1983
the brain death bill also, we hoped, would reassure a medical
community fearful of putative public inability to understand
and accept brain death. Our program worked collaboratively
with the other organ procurement program in the state, the
Delaware Valley Transplant Program, Philadelphia, the Pennsyl-
vania Department of Health, the Pennsylvania Catholic Conference,
the Pennsylvania Medical Society and the Hospital Association
of Pennsylvania in aggressively seeking passage of the Uniform
Determination of Death Act during 1982. We conducted a vigorous
letter writing campaign seeking medical professional and public
support, sought and received press attention for the Bill and
testified at legislative hearings in support of passage. This
educational effort was very successful, surprisingly little
opposition was encountered and the Bill was passed during Decem-
ber, 1982. It is too early to tell whether or not the passage
of this legislation will reassure the many physicians who hesi-
tate to cooperate in organ procurement because of their fear
that the public cannot accept death pronounced on the basis of
destruction of brain function.
Perhaps one of the less well recognized functions of public
education is the impact it has on health professionals. Doctors
and nurses are also media consumers and public education can help
to persuade health professionals that organ procurement and brain
death are acceptable to the general public. The health professions
are generally conservative and frequently tend to follow rather
than to lead public opinion. Yet, I am sceptical of the utility
of costly advertising efforts as I have seen them employed in
148
Testimony of DONALD W. DENNY p. 14
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science" and Techno-logy -
U.S. House of Representatives
April 13, 1983
this area in the past. Professionally produced public service
announcements focusing on organ donation have almost always
been directed toward the educated, white middleclass audience.
Much more effective, I believe, would be programming and public
service announcements directed toward segments of the population,
i.e., working class ethnics, black Americans, Spanish-speaking
Americans and other population subgroups. I feel that little
is to be gained through educational efforts which do not employ
the mass media; highly labor intensive public speaking campaigns
directed toward schools and civic groups, for example, have
little impact. The American Advertising Council does take on
projects for non-profit organizations and activities. Perhaps
this group of professionals could be prevailed upon to contribute
time and talent to the production of effective mass market
public education.
Since, in my experience, approximately four out of five.,
families offered the opportunity to donate will decide favorably,
I believe that the most effective allocation of current funding
available would be to invest in the education and motivation of
health professionals to recognize and refer potential donors.
Despite very heavy favorable media attention .to organ donation,
transplantation and brain death in the greater Pittsburgh area,
no more than one out of ten donor referrals to our program is
at the request of the family. The death of a loved one is so
painful, the families are generally so preoccupied with their
loss, that they do not think of organ donation. It must be
offered to them. The role of the physicians and nurses who care
for the patients and are in a position to recognize donors and
to refer them to the local organ procurement programs therefore
149
Testimony of DONALD W. DENNY p. 15
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
becomes critical. The education of health professionals and
the establishment of institutional policies which will enhance
organ donation should, I believe, be the primary areas for the
investment of time, energy and money. I must recognize,
however, that many of my colleagues do not. agree with me.
This is the philosophy which has been followed at both
organ procurement programs with which I have been associated as
Director. I joined the newly formed Transplant Foundation at
the University of Pittsburgh School of Medicine in January,
1978, after nearly four years with the Delaware Valley Trans-
plant Program. Both programs were established at the outset as
independent not-for-profit corporations governed by Boards of
Directors composed of physicians closely involved with trans-
plantation at associated university medical centers. Financial
and corporate independence allows for flexibility in estab-
lishing and implementing programs designed to achieve procure-
ment goals. This Committee will hear evidence presented by
other expert witnesses which strongly suggests that such inde-
pendent organ procurement agencies are more economical and more
successful than are programs which are functions of hospitals
or universities.
In describing the philosophy and the programs which I have
found successful in organ procurement, I will focus on the
Transplant Foundation at the University of Pittsburgh and our
efforts during the past five years. Although kidney transplan-
tation had been initiated by the University's School of Medicine
in 1964, the program had remained relatively small until it was
150
Testimony of DONALD W. DENNY P-16
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology -
U.S. House of Representatives
April 13, 1983
reorganized in 1977 under the direction of Thomas R. Hakala,
M.D. Growth of the transplant program had not been limited by
the number of patients referred for renal transplantation,
witness the fact that almost 100 ESRD patients were on our
waiting list in late 1977. Instead, the major handicap had
been the shortage of available kidneys. Until 1978, the Univer-
sity was entirely dependent upon kidneys which could be recovered
at the University Health Center of Pittsburgh or could be imported
from other centers in the nation. No organized effort existed
to seek the collaboration of other area hospitals in recognizing
and referring donors. In the fourteen year history of the
renal transplant program at Pitt prior to 1978, only one donor
had provided organs at a hospital outside the University Health
Center. Clearly the community hospitals offered an untapped
source of organ donors.
Two major programs were planned and implemented during. .
1978 for developing organ procurement at approximately 90 hospi-
tals in a geographic area including western Pennsylvania, eastern
Ohio and northwestern West Virginia: (a) an educational program
for health professionals and (b) a comprehensive organ retrieval
program, which would provide 24 hours-a-day services for the
coordination of the donation process and for the surgical re-
trieval and preservation of donor kidneys in outlying hospitals.
The educational program emphasized dissemination of infor-
mation concerning the need for kidneys, donor criteria, evalua-
tion and management, the medicolegal aspects of donation and
brain death, the psychology of grief and its effect on organ
donation, the surgical techniques of organ retrieval and the
services provided by the Transplant Foundation team. I was
151
Testimony of DONALD W. DENNY p. 17
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
given responsibility for implementing this program.
We followed a five-step plan. First, the need for educa-
tional materials was recognized and appropriate brochures, posters,
phone stickers and handbooks were developed. Secondly, a direct
mail campaign utilizing personal letters and follow-up phone calls
was initiated to establish contact with physicians in influental
positions within area hospitals for the purpose of scheduling
educational programs. Third, presentations were scheduled and
carried out at meetings of medical staffs, critical care nurses
and hospital administrators. Fourth, in those hospitals in which
contacts could not be made with supportive staff through mail and
phone efforts, I sought cooperation and speaking opportunities
through unscheduled individual contacts with key hospital personnel
Fifth, follow-up personal contacts were planned and carried out
on a regular basis to strengthen and maintain the level of aware-
ness and to facilitate the formation of strong purposeful rela-
tionships with important keystone professionals.
We have continued to follow this program throughout the past
five years. Experience has proven the value of personal contacts
through phone, mail and direct visits with physicians and nurses
in critical care areas. Too frequent contact can be interpreted
as unwarranted invasion of professional responsibility, whereas
very infrequent contacts do not maintain the visibility for organ
donation we strive to achieve. We find that contacts approxi-
mately four times a year are most effective. An effort is made
to enhance identification of these health care professionals
with our program through the distribution of inexpensive calendars,
152
Testimony of DONALD W. DENNY P-H
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology -
U.S. House of Representatives
April 13, 1983
penlights, pens and other items with our logo, name and telephone
number. Personnel changes in area hospitals frequently necessi-
tate repeat educational programs.
Our efforts to acquaint physicians and nurses with our need
for organs and to excite them about the possibility of coopera-
ting with us were and are today met with a variety of responses.
Many health professionals were warmly receptive, hungry for infor-
mation and eager to assist for purely humanitarian reasons. Many
others were indifferent and unresponsive or aloof and unwilling
to help because of perceived medicolegal problems. A few were
interested in helping because they anticipated that cooperation
would possibly be used to their benefit politically. If their
needs were not met, they quickly lost interest. And, finally,
a very few were openly hostile; more than once I was summarily
ejected from a hospital or told that I was presumptious for seek-
ing cooperation in establishing our donor program in a hospital.
One becomes rather thick-skinned and if one approach does not work
there are usually other approaches which can be taken. Almost
always we can find someone in a given hospital who is interested,
receptive and helpful. What I want to emphasize, however, is
that the direct humanitarian appeal is sometimes not effective
in securing cooperation of health care professionals.
Health care is not unlike other areas of human endeavor in
that it is affected by politics, power struggles, inertia, fear,
vanity and money. Motivation is often, but not always, complex,
and frequently includes factors other than a desire to help
others. Development and the growth of a donor program must re-
cognize and accept this reality and, if possible without compro-
mising individual and program principles, work with it or, if
necessary, work around it.
153
Testimony of DONALD W. DENNY p.19
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Techno-logy -
U.S. House of Representatives
April 13, 1983
The most important inducements which are effective are the
solace organ donation provides the health professional and the
humanitarian appeal of helping others, both the donor family
and the transplant recipients. Health professionals, like all
of us, dislike failure. The death of a patient is an assault
on their feelings as caring people and an affront to their
professional competence and identity. Their tendency in the
face of patient death is often to attempt to distance themselves
emotionally from the pain of failure. What we can offer doctors
and nurses is a way of diminishing pain of failure. We do not
put it that way to them, of course. We talk instead of the
lives of the recipients which can be saved and the solace the
family can realize through transplantation of the donor's organs.
There is genuine satisfaction for a physician or nurse in help-
ing both the family and the recipients through participating in
organ donation, but what most get out of the experience, I
believe, is a restoration of their own self-regard and emotional
equalibrium. Participating in organ donation tends to diminish
their sense of loss and failure. But, again, for some this is
not enough. And for a very few, nothing appears to be enough
to secure their active involvement.
The personal relationship developed between the representa-
tive of the organ procurement team and physicians, nurses and
other hospital staff is also a major factor in developing an
organ procurement program. In our program, the organ procurement
coordinators (there are now four of us) are the most visible of
the team members. We make initial contacts, provide the educa-
tional programs for doctors and nurses, receive donor referrals,
154
Testimony of DONALD W. DENNY p. 20
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
collaborate on-the-scene throughout the entire donor process
(evaluation, management, discussions with family, surgical re-
moval of the organs), call, write and return in person to provide
feedback about the transplant outcome. In the process we strive
to develop a relationship based on trust, collaboration, recog-
nition, personal regard and shared experience. The strength of
the relationship enhances and sustains other motivational factors
which may be operational.
Nothing succeeds like success, however, and a positive ex-
perience of being involved in recovering organs from a donor is
very reinforcing for most physicians and nurses. Their sense of
satisfaction almost always guarantees their future support. But,
in order to provide this kind of positive experience, the entire
process must be handled efficiently, tactfully and knowingly from
beginning to end. The second major component of our program, the
system for coordinating the donor process and recovering the' or-
gans is based on our belief that only transplant professionals
have the time, committment and attention to detail which are
necessary to ensure that the experience and the outcome are both
positive. Some organ procurement programs appoint a nurse or phy-
sician on the staff of a community hospital to coordinate organ
donation in that institution. Some programs also train local non-
transplant surgeons to remove kidneys for shipment to the trans-
plant center. We feel that reliance on indigenous health profes-
sionals is fraught with too many opportunities for error, misun-
derstanding and omission of important procedural steps. The organ
donor process from beginning to end is a very complex one, in-
volving critical clinical, medicolegal and psychological variables.
155
Testimony of DONALD W. DENNY p. 21
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science" and Technology -
U.S. House of Representatives
April 13, 1983
Problems, when they occur, need to be handled expeditiously and
sensitively. If they are not the concept of organ procurement
suffers and the enthusiasm for cooperating with our program is
damaged. For these reasons, we believe it is necessary to have
one of our coordinators present in the donor hospital whose sole
purpose is to make the donation process work. Similarly, in the
Operating Room our transplant surgeons are responsible for per-
forming the donor surgery. The techniques are specialized and
not understood by untrained surgeons. Additionally, the trans-
plant surgeon's committment to a positive experience for the
donor hospital's staff and the recovery of viable organs is more
focused because he knows that the success of his program and the
well-being of his recipients is directly at stake.
In summary, the establishment and success of an organ pro-
curement program is not an enterprise which lends itself to a
mechanistic or bureaucratic approach. As with any endeavor
which requires collaboration of people from disparate professions
with differing agendas and dissimilar institutional loyalties,
organ procurement requires constant attention to the establish-
ment, maintenance and repair of a delicate fabric of relation-
ships, as well as dissemination of substantive information and
technical competence.
Yet, no program is so successful that it can sustain itself
solely with the organs recovered in its immediate region. Organ
sharing between 110 organ procurement programs has developed
over the past dozen years in response to need and technical
capabilities. Fully half the kidneys transplanted today have
been surgically recovered by distant procurement programs and
156
Testimony of DONALD W. DENNY p. 22
Hearings on Organ Procurement , and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
transported to the transplanting center. Kidney sharing is facil-
itated by our technical ability to preserve these organs for 48
hours and sometimes longer. Since kidney transplantation is
seldom if ever life-saving therapy and since, until recently,
demonstrably improved transplant survival occurred when attention
was given to matching donor and recipient tissue types, the shar-
ing of kidneys on the basis of computer matching of immunologic
factors has been enthusiastically supported by almost all centers.
The United Network for Organ Sharing (UNOS) is an informal network
of approximately 130 transplant and organ procurement programs
which register their patients waiting for renal transplants on a
central computer owned and operated by the South-Eastern Organ
Procurement Foundation (SEOPF) in Richmond, Virginia. SEOPF itself
is a regional cooperative organization of 39 transplant programs,
although its computer provides nationwide services for distribu-
tion of kidneys. The concept of computer matching for kidneys
must not be misunderstood to mean that the computer directs the
placement of that available kidney. Instead the computer merely
sorts through the thousands of potential recipients to identify
those which appear to be suitable matches. The sending center
then selects the recipient center(s) to which it may wish to
offer the available organ, contacts that center by phone and makes
arrangements to transport the kidney if it is acceptable. Sharing
of kidneys is not infrequently influenced by non-immunologic
factors, such as the proximity and close relationship between
sending and receiving centers.
157
Testimony of DONALD W. DENNY p. 23
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science' and Teehno-logy -
U.S. House of Representatives
April 13, 1983
The emergence of extrarenal organ transplantation as an acceptable
therapy for end-stage heart and liver failure patients has in
the past few years resulted in a modification of this informal
organ sharing effort: the collaboration of two or three programs
in surgically recovering organs from a single donor. In this
form of sharing the donor is identified in a regional hospital
of one program. The host program is almost always eager to
recover the kidneys, but has no use for the extrarenal organs.
Rather than see the organs wasted, the host program invites one
or two other procurement programs in need of extrarenal organs
to fly to the donor hospital for the purpose of retrieving the
heart and/or liver. In this model the on-scene coordination of
all clinical, medicolegal and logistics aspects of the donation
process are handled by the host program coordinator. Telephone
communication between the host coordinator and his colleagues
from the extrarenal center(s) facilitates the carrying out of
specialized requirements for the extrarenal centers prior to
the convergence of all of the teams in the donor hospital
Operating Room. All of the programs participating :n organ
recovery share in assuming the responsibility for the costs.
The Transplant Foundation at the University of Pittsburgh
did not initiate intercenter collaborative organ retrieval
(that distinction belongs to the University of Colorado and the
Medical College of Virginia), but it unquestionably has the
most experience in this form of organ (or, more properly, donor)
sharing and has developed the system far beyond its early stages.
158
Testimony of DONALD W. DENNY p. 24
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science- and Technology
U.S. House of Representatives
April 13, 1983
This form of intercenter collaboration was first ittempted by
Pitt in 1980 with the inauguration of our cardiac transplant
program and has become a commonplace activity during the past
two years with the relocation of the nation's largest liver
transplantation program to Pittsburgh. Our program was unable
to generate sufficient numbers of donors for heart and liver
transplantation within our own region and necessarily turned to
other programs with a request for help. The need for help from
other programs is not just a function of the number of available
donors locally. We have a rather large donor program and annually
recover kidneys from 50 to 60 donors in our region. For several
reasons, an available donor may not be suitable for heart or
liver donation. First, patients accepted for heart and liver
transplantation are terminal and will die within days or weeks
unless successfully transplanted. There is often no time to
wait for a local donor. Secondly, unlike kidneys, heart and
livers must come from size compatible donors. Especially in the
case of pediatric recipients, this presents a major problem'
since relatively few small children succumb to brain death.
Our liver transplant waiting list now includes over 30 potential
pediatric recipients under the age of five years. Intercenter
collaboration is imperative especially for these youngsters.
Our experience in seeking the cooperation of other procure-
ment programs recapitulated our experience in asking for the help
of hospitals in our own area. A few programs enthusiastically
came to our aid immediately, most were suspicious and slow to
respond and a very few were indifferent or hostile and totally
159
Testimony of DONALD W. DENNY p. 25
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Techno-logy -
U.S. House of Representatives
April 13, 1983
uncooperative. The primary concern initially voiced by our
colleagues at other programs was their fear that the surgical
technique required for extrarenal procurement would jeopardize
the quality of their donors' kidneys. This is not true but time,
persistence and published data were required to convince many
initially reluctant programs. We still find that there are many
organ procurement programs within the eastern half of the United
States which are unwilling to collaborate with us in the recovery
of extrarenal organs. Some of these programs are merely insular,
some are unwilling to help because of the extra effort required
and some are reluctant to work with us because they fear our
involvement will somehow compromise their own procurement efforts.
Although intercenter collaboration was difficult for us to
establish, the concept has become increasingly popular. The
statistics reveal our success. During 1981, we received 175
referrals of extrarenal donors from other programs and were able
to recover 20 livers and 9 hearts in cooperation with distant
renal procurement teams. In 1982, we received over 520 referrals
from other programs and recovered 63 livers and 18 hearts with
outside help. Three-fourths of the livers and four-fifths of
the hearts transplanted at the University Health Center were
recovered through the generous collaboration of other regional
procurement programs. We are proud, too, that Pittsburgh is
also a major provider of extrarenal organs to other centers.
When we are unable to utilize an available extrarenal organ from
a donor in our region, we always seek to work collaboratively
in the recovery of these organs with other programs in need.
160
Testimony of DONALD W. DENNY p . 26
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology •
U.S. House of Representatives
April 13, 1983
One of the major factors which aided us in developing inter-
centet cooperation was the opportunity for communication and the
development of trust afforded by the professional association of
organ procurement coordinators, the North American Transplant
Organization (NATCO). Workshops on extrarenal organ procurement
sponsored by NATCO provided an opportunity for concerns to be
discussed and resolved. NATCO's annual training course for pro-
curement coordinators provides intensive orientation through
extrarenal procurement for new procurement personnel.
NATCO has also been a major force for the sharing of extra-
renal organs. The major system used by procurement personnel to
locate recipients for available extrarenal organs is sponsored
by NATCO. At this time, approximately 17 transplant centers are
involved in extrarenal organ transplantation in the United States
and Canada. This number will become swollen during the next
several months when at least five additional centers will inaug-
urate heart transplant programs and another six centers will
begin transplanting livers. Last year, NATCO recognized the
problem faced by organ procurement personnel in locating suitable
recipients for extrarenal organs which may become available in
local community hospitals. The UNOS computer system has great
utility in helping to distribute kidneys, but is much less
effective in the area of extrarenal organ sharing. Because of
very limited capability for preservation of extrarenal organs
(hearts can be preserved for no more than 4 hours and liver for
approximately 10 hours), these organs cannot be removed from
161
Testimony of DONALD W. DENNY p. 27
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science' and Techno-logy •
U.S. House of Representatives
April 13, 1983
the donor before a suitable recipient is identified. Transplan-
tation must occur immediately after the donor surgery. Size,
blood type compatibility, geographic distance and urgency of
need are the primary factors considered in coordinating recip-
ient selection of extrarenal organs. Procurement coordinators
who receive a donor referral during non-office hours or who are
evaluating a donor at a community hospital and wish to discuss
extrarenal donation with the donor family cannot access the
UNOS computer to review current extrarenal needs" across the
country. NATCO recognized the problem and established a 24
hour-a-day telephone service for informing organ procurement
programs of extrarenal needs. This free, volunteer service
utilizes a recorded message system which can be accessed from
any phone in the United States or Canada. Updated as needed
(usually once or twice a day) the recording lists by center the
type of organs needed, a priority status code indicating urgency
of recipient need, the donor criteria (size, weight, blood
type), geographic limitations to procurement, the name of the
procurement coordinator to be contacted and the phone number of
each participating extrarenal center. Fifteen extrarenal centers
now use the system to acquaint organ procurement programs with
their donor needs.
During the first, six months of service, the NATCO 24-ALERT
System (the name is taken from the System's mnemonic phone
number) facilitated the recovery and transplantation of 30
hearts at 9 centers, 48 livers at 5 centers and 1 heart-lung
bloc. Success of the 24-ALERT System and temporal limitations
which prevent heart and liver procurement much beyond 1,000 miles
162
Testimony of DONALD W. DENNY _ P-2*
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
from an extrarenal center have prompted NATCO to plan to divide
the System into two complimentary geographic components. Within
the next month a 24-ALERT WEST will be established to handle the
western half of the country, while the original System will con-
tinue to convey information of relevance for the eastern half
of the nation.
The System is not perfect but it works better than anything
else available at this time. The UNOS computer, in fact, is used
only infrequently for extrarenal organ sharing because of the
greater effectiveness of the NATCO 24-ALERT System. As is the
case with the UNOS computer program for kidney sharing, the
current System provides information to the donor program staff
and leaves up to them the decision concerning which extrarenal
program is to be contacted. Undoubtedly some extrarenal programs
are often not contacted because of factors unrelated to the
urgency of their need. Center-specific problems with the quality
of their procurement services are a major impediment, for example,
for some extrarenal programs. No distribution system will be
effective which attempts to compel cooperation between programs
which do not trust one another.
Inter-regional extrarenal procurement is expanding rapidly.
The University of Pittsburgh alone has worked cooperatively with
over 40 other organ procurement programs during the past two
years. On 12 occasions we have participated with two other pro-
grams in simultaneously recovering organs from a single donor.
At this time the necessary trust in the technical competence of
other transplant surgeons which would allow distant procurement
163
Testimony of DONALD W. DENNY p. 29
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Techno-logy -
U.S. House of Representatives
April 13, 1983
and sharing of extrarenal organs (rather than donor opportunities)
is not well developed; most extrarenal transplant surgeons still
desire to have donor organs removed by members of their own team.
With experience and time, however, this inhibition will be over-
come and hearts and livers will be exchanged as kidneys are now.
One major problem will probably continue to exist for the
foreseeable future. Because of the delicate nature of lung tissue,
long distance procurement of heart-lungs and single isolated lungs
now require the tranportation of the donor from the donor hospital
to the center where transplant surgery will be performed. Recent
success with the transplantation of heart-lung blocs warrants
continued efforts in the transplantation of these organs. The
willingness of most organ procurement programs to transport a
local donor hundreds or thousands of miles to an extrarenal
center for the recovery of heart-lungs or isolated lungs is
strongly inhibited at this time by the fear of the procuring
program that the quality of the kidneys will be jeopardized.
Another factor limiting the availability of these organs is that
many families which are willing to donate are unwilling to subject
their loved ones to transportation to the donor center for organ
retrieval. The University of Pittsburgh and Stanford University
have the only heart-lung transplantation programs in the United
States and both are seriously compromised in their ability to
offer heart-lung transplantation to the many candidates for this
surgery because of the shortage of suitable donors. Montefiore
Hospital, New York City, has a similar problem in developing their
lung transplantation program.
164
Testimony of DONALD W. DENNY p. 30
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science" and Techno-logy -
U.S. House of Representatives
April 13, 1983
The current system for the procurement and sharing of kidneys
and extrarenal organs is essentially sound, I believe. The exist-
ing system of regional procurement programs is in principle the
most effective means of cultivating the growth of donor programs
at the community hospital level. Regionalization facilitates
the personal contacts which are essential and regional idiosyn-
crasies are best recognized and responded to on a regional basis.
Inter-regional collaboration will continue to grow as need and
familiarity with the benefits of donor and organ' sharing increase.
Yet the fact that no more than one-third of the potential donors .
in this nation now yield organs for transplantation indicates
that the system for organ procurement at the regional level needs
strengthening, especially at its weakest point: the interface
between the organ procurement programs and the health professionals
in the community hospitals who are in a position to recognize
and refer donors. I have the following recommendations:
(J . ) It is time that transplant and organ procurement profes-
sionals seek the help of others outside the transplant
community. A national task force should be formed of
representatives of organ procurement and transplant
specialty groups and other significant health profes-
sionals' organization to identify problems inhibiting
referral of organ donors to regional programs and to
recommend solutions on a national level. Such a task
force should include leaders from organizations which
represent physicians and nurses likely to encounter
donors, i.e., neurosurgeons, neurologists, critical
care physicians, emergency physicians, pediatricians,
165
Testimony of DONALD W. DENNY p. 31
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
critical care nurses, as well as leaders from organ-
izations of hospital administrators and other relevant
groups .
(2.) Rules and regulations should be enacted on the state
and/or national level which would require that every
hospital seeking certification (a) enact a policy and
operational protocol for the determination of brain
death; and (b) develop a policy and protocol for the
recognition and referral of potential organ donors to
the nearest regional procurement program. (In Pennsyl-
vania, with the support of the Secretary for Health,
efforts are now underway to have both of these regula-
tions adopted by the State Department of Health as
requirements for hospital certification.)
(3-) A financial incentive should be built into the federal
Medicare reimbursement system which would reward hospi-
tals from which post mortem donor kidneys are recovered
for transplantation. No new legislation should be re-
quired, since Medicare now funds renal transplantation
and kidney procurement. This should be especially
attractive to the taxpayers and the federal government
since kidney transplantation is considerably less ex-
pensive than chronic dialysis. (Most post mortem kid-
ney donors are also potential extrarenal donors and
this incentive system would also enhance opportunities
for extrarenal organ procurement.)
166
Testimony of DONALD W. DENNY P-32
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Techno-logy -
U.S. House of Representatives
April 13, 1983
(4.) Areas of this country still exist which provide few if
any organs for transplantation. The problem in part is
the failure of the regional organ procurement programs
effectively to educate physicians and nurses. Streng-
thening education for health professionals is essential.
One step in this direction has recently been taken by
NATCO, which has established a 24 hour-a-day organ
donor information and referral hotline for doctors,
nurses and other hospital staff who have questions
about donation or want to refer potential donors but do
not know how to contact their local procurement program,
Staffed by trained organ procurement coordinators, the
hotline (dial 800/24-DONOR ) needs wide exposure in the
medical community to be effective. Support for this
and other efforts to strengthen professional education
is sorely needed.
(5.) Public education efforts should be stepped up, with
emphasis given to developing mass media educational
opportunities focused on subgroups of the population.
The National Advertising Council should be asked to
take on a national project for public education.
(6.) My final suggestion is one which should be self-
evident from my testimony. There is a real need for
the accumulation of data on organ donation, organ dis-
tribution and transplantation. Some data is now
collected on renal donation and transplantation by
the Health Care Financing Administration, but no
167
Testimony of DONALD W. DENNY p. 33
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science" and Technology -
U.S. House of Representatives
April 13, 1983
figures are available for the country as a whole con-
cerning the number of potential donors, the number of
potential donors referred to organ procurement programs
but from whom organs are not recovered, the number of
extrarenal organs needed, recovered and transplanted.
Some very practical questions need to be answered.
For instance, how many suitable pediatric donors between
the ages of six months and five years are potentially
available? The number of small children being referred
for liver transplantation is growing geometrically; we
may be faced with the fact that there will never be a
sufficient number of younger donors to meet the need.
We won't know unless we investigate.
168
Testimony of DONALD .W. DENNY _.
Hearings on Organ Procurement and Distribution
Investigations and Oversight Subcommittee
Committee on Science and Technology
U.S. House of Representatives
April 13, 1983
BIBLIOGRAPHY
(1 ) Cooper, K.D., et al , "The Potential Supply of Cadaveric
Kidneys for Transplantation", Transactions of the American
Society of Artificial Organs, vol. 23, pp. 416-421 (1977)
(2 ) Project to Reduce Waiting Times for Cadaveric Kidney
Transplants in Michigan: Phase I Final Report, Transplan-
tation Society of Michigan (1982)
(3 ) Barb K.J., et al, "Cadaveric Kidneys for Transplantation:.
A Paradox of Shortage in the Face of Plenty", Transplan-
tation, vol 35, no. 5, (1981)
(4.) Statistical Abstracts of the United States, Department of
Commerce, Bureau of the Census, 1982-1983
(5.) Council on Scientific Affairs of the American Medical ..
Association, "Organ Donor Recruitment", Journal of AMA ,
. vol 246, no. 19, (1981), p. 2157
(6 ) Gallup Organization, Inc., Attitudes and Opinions of the
American Public Toward Kidney Donation, (prepared for the
National Kidney Foundation, Inc., New York), Princeton, N.J.
(1983)
169
Mr. Gore. Thank you very much, Mr. Denny. I commend your
entire remarks to the attention of those reading this record and
your recommendations will no doubt, many of them be included in
the subcommittee's report.
Dr. William Pfaff, past president of the South-East Organ Pro-
curement Foundation at the University of Florida College of Medi-
cine in Gainesville, and a noted kidney transplant specialist in his
own right. We are delighted to have you here.
Please proceed.
4.iPrv Pf£f£- Thank you. I was asked to appear today to describe
the bouth-East Organ Procurement Foundation [SEOPF]. SEOPF
actually has been enlarged from its original membership of eight to
some 40 members.
Those of you who live north of here will be surprised to learn
that New Jersey is also in the Southeast, as is Indiana. So the
rough boundaries
Mr. Gore. We are an ambitious region.
Dr. Pfaff. The rough boundaries are New Jersey to Indiana
Louisiana to Florida. Almost all of the programs that are trans-
planting and procuring organs in this areas are members of our
foundation.
SEOPF was established with the hope and expectation that
tissue typing and tissue matching would result in improved graft
survival. That was the first premise.
Second, there was a realization that an excess of supply at one
site might coincide with a need at another site, that there was an
advantage to mutual education and a discipline that was dramati-
cally unfolding. Finally, there was a need for uniform tissue typing
laboratory practices. As the organization has matured, it has con-
tinued to work at these goals, and then has established some others
in a variety of activities.
The current means of exchange is heavily dependent upon our
computer network. We list, from the members alone, something in
excess of 2,200 patients.
Approximately one-third of the patients who are being trans-
planted in the country receive their grafts among this membership
ol some 40 institutions.
The means of distribution of kidneys is principally on the basis
ot tissue typing characteristics. We are trying to take advantage of
the immunology that we have gradually uncovered over these
years in order to provide a more successful graft, for there are
some individuals who absolutely need a well-matched transplant in
order to be successfully managed.
The computer network distribution system has been expanded to
™e rest of the country, and the organization that is an outgrowth
of the SEOPF technology is called UNOS [the United Network for
Organ Sharing.]
Now some 138 transplant programs nationwide, thus, are using
this single means of distributing kidneys. When I left Gainesville
yesterday, on the plane with me there was a kidney that was des-
tined for Minnesota. Another had left on the earliest plane from
Gainesville to go to Mississippi. By the same token we expect that
Minnesota is going to return the favor for the same purpose,
namely, to provide, again, a well-matched organ.
170
In practical terms if a kidney becomes available at the Universi-
ty of Florida or one of our nearby hospitals — we are in a semirural
area — that we tissue type the donor, look at the computer readout
and first priority, and that is to distribute the well-matched organ,
irrespective of local need.
We run the computer program and identify the potential recipi-
ents who are listed in priority of their organ matching characteris-
tics and then call the appropriate center. Each of the centers have
24-hour numbers and 24-hour personnel to advise them of this
opportunity.
The level of activity of SEOPF members, included 604 kidney
transplants from July 1 through December 31, 1982. During the
same time period, half again that number of organs were procured.
In other words, the transplant rate is 1,200 per year, the procure-
ment rate is 1,800 per year. Thus there is an excess that is generat-
ed within the region and that is distributed to non-members as the
net of about 250 or 260 excess kidneys per year.
The total incidence of sharing amongst the donating centers is
some 59 percent. The majority of the kidneys that are procured in
the Foundation are shared with other centers, both within and
without the Foundation.
The other areas in which we have become interested in is scien-
tific data. Somewhere along the line we needed to find out what we
were doing. The points that Mel Williams made to you earlier
today regarding the five factors that have import and the varied
success of transplantation are factors that have been covered,
uncovered, sustained and demonstrated individually in other
programs.
All of that information was generated within one program and
that was from the cooperative efforts of the SEOFP membership, so
that we achieved some specific knowledge about transplantation,
about organ preservation, sharing, and procurement as a conse-
quence of sharing our information.
In 1973, with the institution of the medicare law that covered
renal failure, the funding for the voluntary registry that trans-
plant programs have maintained for a good number of years
ceased.
We were promised a medical information system. That has never
happened. The only sources I have for making decisions about pa-
tients are the SEOPF data that addresses only transplant patients
and my local network, that is, the Florida End-Stage Renal Disease
Network. We have excellent data on every dialysis and transplant
patient in the State of Florida. I know the relative risks of dialysis
and transplantation, of different modes of transplantation, as that
is expressed in age, causative diseases and also associated diseases.
I would urge those of you who are interested in having informa-
tion available to make such decisions that you reconsider the ef-
forts that have been suggested in some areas of our own Govern-
ment to cease funding of the networks. To me, it would be
crippling.
Transplantation of heart, liver and pancreas is varied in this
country, rapidly growing. You heard a number of people describe a
number of existing programs.
171
Frankly, within our own foundation we have not kept up with it.
We have not established a program for sharing these organs. We
cannot address the costs of distribution of other organs, at least as
an addition to the elements of exchange to the End-Stage Renal
Disease Program. We would have to establish some other form of
funding to do that, because of the disallowance you have heard dis-
cussed earlier today.
Can the basic system be used for organ exchange? Yes. The
means by which we exchange organs really is adaptable, I think, to
almost any organ.
There are differing needs in terms of the ability to maintain the
organ outside the donor, even in using the preservation techniques
we have today. The heart is very urgent, the pancreas, perhaps, the
most urgent of all. It appears that the liver can be preserved for at
least a number of hours. The kidney, can be sustained for 1 to 3
days. Each of those developmental problems of organ preservation
is going to put different kinds of restrictions on us in terms of both
procurement and, most importantly, sharing of organs.
Yet we come to that subgroup of our patient populations who ab-
solutely need a well-matched organ in order to be successfully
transplanted, and we need to address that question as we proceed.
We are increasing our success at all forms of transplantation.
Each one of us looks at our own program and questions. "Have we
done better this year?" We are proud if we have; we are disappoint-
ed if we haven't — we are dashed if we haven't.
The economics of transplantation are a matter of continued con-
versation in your sphere and in ours. For these new areas we don't
have a solution. We have come to you for a solution. We need to
expand this dialog, from successful kidney transplantation to in-
creasing success in other areas.
The problems, as I see them, are identification of additional
appropriate transplant recipients. That is based on the delivery of
sound, scientific information, both to patients and to other
professionals.
I think that you have heard that often enough. I would not reit-
erate further.
We are doing a good job of kidney procurement in our area of
the country. I think we are doing a fairly good job in terms of extra
organ procurement.
I would ask whether that is the product of our cooperative work,
of our group effort, of our mutual pride, because I think that that
is something that might be exported to other areas of the country.
There are very few large regional organizations. They tend to be
metropolitan or a small area. Yet, much of our ease of working
with one another has been through sera exchange, through the his-
tocompatability laboratories and through our computer network.
I would favor expansion of the regional concept with interre-
gional cooperation. We have some patients who have uncommon
blood type, uncommon tissue types and their opportunity for a
matched graft even within our rather sizable program may be in-
frequent. Thus, expansion of the number of cooperating centers
will expand the potential for cross-matching between donor and re-
cipient, we will have a much better likelihood of getting these long-
waiting individuals a successful transplant.
172
Thank you.
Mr. Gore. Thank you very much.
[The prepared statement of Dr. Pfaff follows:]
173
Testimony of William Pfaff, M.D., Concerning Organ Sharing Transplatation
SUMMARY OF TESTIMONY OF WILLIAM W. PFAFF, M.D.
CONCERNING ORGAN SHARING IN TRANSPLANTATION
PRESENTED TO THE
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
UNITED STATES HOUSE OF REPRESENTATIVES
APRIL 13, 1983
The success of transplantation can be improved by inter-institutional
cooperation. The Southeastern Organ Procurement Foundation (SEOPF) is an
example of a voluntary organization of forty transplant centers. The Foundation
has created a computer network to facilitate organ exchange between 140 trans-
plant programs, listing approximately 5,500 prospective renal transplant recip-
ients. Through the membership's tissue typing laboratories, uniform techniques
generate information that allows priority distribution of organs to individuals
who are most likely to benefit from the advantages of histocompatibility
matching. The efforts of the membership have resulted in advances in organ
procurement and preservation, professional and public education, and scientific
information. The technology is adaptable to other organs.
23-029 0-83-12
174
Mr. Chairman and members of the committee, I am William W. Pfaff, M.D. of
Gainesville, Florida. I am a professor of surgery at the University of Florida,
Director of the Kidney Transplantation Program. I am the immediate past
President of the Southeastern Organ Procurement Foundation (SEOPF) and am a
member of the Board of Directors of that organization. I have been asked to
describe existing organ sharing, specifically as practiced in SEOPF.
Under the leadership of David Hume and Bernard Amos, SEOPF was founded in
1968 by several transplant programs that were predominately mid-Atlantic in
location, to explore the feasibility and effectiveness of organ sharing to:
a. Verify the worth of tissue typing to improve graft survival in the
general transplant population.
b. Provide an opportunity for transplantation for individuals who
required a well-matched graft.
c. Aid in the development of organ preservation.
d. Foster effective use of kidneys when a recipient was not available
locally.
e. Develop uniformity of tissue typing techniques.
There has been growth of SEOPF over the ensuing fifteen years. There are
now forty members embracing an area that extends from New Jersey to Indiana to
Louisiana to Florida. The membership performs 1,200 cadaver transplants per
year, approximately one-third of the national activity and serves approximately
one-third of the dialysis population suffering from end stage renal disease
(ESRD).
With maturation of the organization, the original efforts hava become more
intense and our purposes are broadened.
175
TISSUE TYPING
During the past decade, tissue typing has become ever more complex. There
are new antigen systems, which are surface markers on cells, that allow identi-
fication of similarities between a potential donor and recipient. Successful
organ exchange depends on the capacity to identify these antigens with equal
facility in exchanging institutions. Participating member laboratories must
mature in their capability at an equal pace with trend-setting institutions.
SEOPF has initiated peer review amongst its members by on-site workshops, mailed
cell exchanges that allow grading of results to ensure uniformity, inspections
of laboratories that have undergone change in personnel or that have suspected
deficiencies in performance.
ORGAN MATCHING
As the Organization and the pool of prospective recipients grew, automated -
identification of the most appropriate recipient became necessary. In an
evolutionary fashion, computer programs have been refined to allow participating
institutions to identify all prospective recipients for a particular kidney.
The putative recipients are categorized by shared antigens listed in order of
greater to least.
Prospective recipients are identified by name, age, blood tissue typing
data, antibody status, duration on the computer list, location of the recipient
center and telephone numbers for contacting the responsible institution.
By general agreement, the first priority for sharing is a perfect tissue
typing match. At" lesser grades of sharing, other factors assume priority,
including distance, multiple candidates in one center and additional immunologic
factors.
Unless delegated, as will be discussed further, the donor center maintains
176
responsibility for selecting a prospective recipient center and transporting the
organ thereto.
CROSS MATCHING
One barrier to a successful transplant or the culmination of an intended
sharing is the occurrence of antibodies, proteins that are capable of injuring
foreign antigens. As a result of blood transfusions, pregnancy, or prior
transplants, a patient may generate antibodies that are capable of killing the
cells of other individuals. Of patients now listed in the computer, forty-six
percent have antibodies directed against greater than sixty percent of the
general population; twenty-seven percent have antibodies against an excess of
ninety percent of the population.
For economy of dollars, time, and most important, the successful use of
organs, it is important to be able to predict whether the serum of a recipient
at a distant center will or will not kill the cells of a donor. If so, this is
a positive cross match and that recipient is eliminated for the same effect will
be wrought on the kidney or other organ.
In SEOPF, we particularly circumvent this problem by sharing serum of pro-
spective recipients who have highly reactive antibody so that the donor center
has cross matching material at hand. In consequence the donor center performs
preliminary cross matches on all prospective recipients in whom antibody might
present a problem.
When sharing an organ with non-members, there is a greater possibility that
a positive cross match will ensue. It would be desirable if the system described
above or some other alternative could be adopted for inter-regional sharing.
ORGAN PROCUREMENT
All members of SEOPF assume a responsibility for organ procurement. The
898
111
31%
250
28%
209
23%
90
10%
72
8%
177
statistics for7/l/82 - 12/31/82 are expressed as follows:
Total cadaver kidneys procured
Kidneys used in local center
Kidneys shared in SEOPF
Kidneys shared outside SEOPF
Kidneys not used (local decision)
Kidneys not used after sharing
In the same six-month period:
New SEOPF patients registered on computer
SEOPF patients transplanted
Kidneys from local sources
Kidneys from SEOPF
Kidneys from outside SEOPF
These data provide an overview of the relative success of organ procurement
in SEOPF. Pertinent conclusions are that: a) Kidney procurement in the region
outstrips transplantation; b) SEOPF is a net exporter of kidneys, providing more
kidneys to non-members that receiving same; c) two-thirds of kidneys obtained in
SEOPF are being shared; d) the discard rate of unshared kidneys is probably
acceptable. (Note: Kidneys are discarded for a variety of reasons, including
anatomic or functional abnormalities, systemic findings in the donor, or failure
to identify an appropriate recipient.)
The rate of organ procurement has steadily grown, and the ratio of
transplants to nev patients has decreased.
SCIENTIFIC ACTIVITIES
In the mid-70' s, it was recognized that our combined efforts could poten-
tially answer many of the vexing questions that were raised by the varied
689
604
277
46%
250
41%
77
13%
178
processes and circumstances that attend the complex steps that are involved in
organ transplantation. These included patient survival statistics, graft
success, differing drug protocols, transfusion policies, means of organ preserva-
tion, import of tissue typing characteristics in different patients. In the
absence of a national information registry, this pooled information has become
an important resource for understanding the changes that are occurring in
transplantation success and to allow comparison of individual programs with a
broader experience. Multivariant analysis has been applied to gauge a variety
of risk factors, so that one might modify the circumstances under which one
might proceed with a transplant. A number of important reports have added
assistance in answering our constant queries as to the effect of variables in
patient selection and management.
Parenthetically the data bank is currently limited to transplant patients,
lacking information on the majority of ESRD patients who are managed by
dialysis. At present, comparative data is available only through the ESRD
networks. In my own state of Florida, I depend on the Network 19 data to help
make the judgment as to the relative risks of various modes of dialysis and
transplantation, including information as to the major risk factors. I thus
strongly applaud the efforts of those members of the House of Representatives
who favor continued and augmented funding for the Networks. The information
derived has fiscal and rehabilitative import.
INNOVATIONS
In 1977, the technology of computer exchange was made available to SEOPF
non-members by creation of an entity known as UNOS, the United Network for Organ
Sharing. The cost is limited to the purchase of a terminal, direct charges for
telephone and computer time, and a minimum fee for the accountable
179
administrative expenses to maintain this service. Currently 100 UNOS programs
list approximately 3,000 prospective recipients so that the combined UNOS-SEOPF
listing includes 140 programs and 5,500 patients. Organ exchange can thereby be
facilitated amongst UNOS members as well as between SEOPF and UNOS members.
A more recent experiment was the establishment of a 24-hour staff at SEOPF
headquarters in Richmond, Virginia. The aim was to use these individuals to
make the many phone calls that are often involved in the placement of a shared
kidney, to arrange transportation, tying in with commercial airline computer
services, to take advantage of charter flights that are underway to reduce
transportation, and to free local personnel to pursue their many other tasks in
organ procurement and professional and public education. This project was
established as the result of a grant by the American Kidney Fund and
continuation will be determined by the SEOPF Board of Directors in one month.
EDUCATION
The Foundation has been heavily involved in education of peers in
transplantation, fellow professionals, our patients and the public. Manuals for
tissue typing, organ procurement and organ preservation are regularly edited as
innovations lead to improved techniques. We have undertaken dialogues with
neurologic and neurosurgical colleagues to urge their cooperation, with critical
care nurses and physicians. Ultimately we are dependent on the public's
understanding. My own bias is that too little has been done and invested in
this specific area.
GOVERNANCE OF SEOPF
Membership in SEOPF is voluntary and is institutional. Each participating
transplant center names a director who has equal voice with all others at
triannual meetings. An Executive Committee operates in the interval, their
180
decisions affirmed by the full Board.
The day-to-day business of the Foundation is conducted by a salaried
Executive Director and his staff.
The many tasks are initiated by committees addressing various distinct
areas, that is tissue typing, education, procurement, et cetera. Participants
include all disciplines involved in procurement, exchange and sharing — histo-
compability technicians, nurses, coordinators, hospital adminsitrators ,
nephrologists , immunologists and transplant surgeons.
COSTS OF SEOPF
The current expenditure for maintenance of the Organization, expressed as
cost per shared kidney follows:
General and Administrative costs $243.91
Computer Network 167.53
Education 128.88
$540.32
The current average cost of obtaining a kidney for transplantation is
$7,729.00. This includes some of the expenses of evaluating patients for
transplantation. The average cost of transporting shared kidneys is $392.00.
SEOPF cost currently forms 6.2% of the total expense.
ASSESSMENT
1. Is this an effective system?
My program sought and has continued membership in the belief and now the
conviction that membership would enhance our performance. This subjective
conclusion is buttressed by ongoing improvement in graft survival in my own and
other programs. While all of this is not directly attributable to membership,
many of the innovations and certainly the emphasis on organ sharing has been a
181
product of our membership.
2. Might these and similar approaches be used in other regions?
Many areas have sharing agreements and varied cooperation in other
activities. The evolutionary broadening of the activities of SEOPF would seem
to have merit to us, yet most of us do not feel that SEOPF as such could exist
as a national organization because of cost and the loss of the extensive
communications we maintain between institutions to complete our tasks. There
would seem to be advantages to regional organization with inter-regional
cooperation.
3. Can the techniques used in kidney sharing be applied to other vital organs?
The criteria for determining priority will differ and needs to be resolved
by centers transplanting the heart, liver or pancreas. As the number of
donating and transplanting centers grow, and as the potential recipient
population swells, it would seem natural to take advantage of the computer
network and the tissue typing laboratories that currently provide these
services. SEOPF has recently initiated a formal extra-renal computer program,
the cost and charge segregated from the kidney program because of Medicare
considerations .
4. Is there increasing success in transplantation?
Not considering the potential for improved graft survival as a result of
new immunosuppressive agents, SEOPF and Florida Network data both show
substantial improvement in transplant function and decline in patient mortality.
The Florida data comparing dialysis and transplantation in the most scrupulous
and controlled fashion, shows no difference in the risk of dialysis and
transplantation, and with broader considerations, shows advantage to trans-
plantations in young individuals. The clear advantage of transplantation lies
182
in reducing morbidity, returning people to productive lives, and reducing the
annual expenditures for end stage renal disease.
5. If the rate of transplantation should increase, can sufficient organs be
obtained to meet needs?
The success of organ procurement efforts varies widely, and probably
reflects the investment of time and personnel by transplant programs and
voluntary agencies. Within SEOPF, more organs are being procured that are being
transplanted by the membership. Isolating by subregions, those states that are
effective in organ procurement demonstrate that within a broad population base
there is sufficient organ availability to allow expansion of transplantation.
It follows that similar effort by all programs would result in far more organs
than are available now.
In addition to local efforts, I would hop that a centralized program using
national media could be repeatedly addressed to the lay public to educate as to
the feasibility and desirability of organ transplantation.
183
South-Eastern
Organ Procurement
Foundation
184
T
ransplantation:
more than a surgical procedure
Organ transplantation has been
one of the most dramatic medical
achievements of this century. The success
of transplantation has been brought
about by advances in surgery, immunol-
ogy, biochemistry, pharmacology, and
bioengineering. No longer an experi-
mental technique, transplantation is
now the accepted form of therapy for
many patients with irreversible loss of
function of many of the body's vital
organs and tissues.
Just as transplantation requires the
cooperation of many disciplines within
the hospital, transplantation is depen-
dent upon the cooperation of many hos-
pitals across an ever-increasing geo-
graphic area.
With over 60,000 kidneys trans-
planted worldwide, a firm foundation
has been laid upon which transplanta-
tion can grow.
A vital force in this growth is. the
South-Eastern Organ Procurement Foun-
dation, a unique collection of physicians,
physician's assistants, surgeons, nurses,
technicians, and administrators.
185
i man sharing and more
01
The South-Eastern Organ
Procurement Foundation
(SEOPF) was founded in 1969 to coordi-
nate the organ sharing activities among 9
medical centers in a 4-state area from Bal-
timore to Atlanta Today, SEOPF is the
nation's largest organ sharing program —
a cooperative of approximately 40 medi-
cal centers covering nearly the entire
eastern half of the United States
The Foundation, a non-profit corpo-
ration, is owned by its member institu-
tions, each of which appoints a trustee to
serve on the Board of Directors.
The primary goal of the Foundation
is to increase the quality and quantity of
organs recovered, to meet the present
and future needs of the transplanting
community. In this effort, SEOPF works
closely with government agencies, indus-
try, and public and private organizations.
186
F
oundation activities
Standing committees of SEOPF recommend policies for Bos
in the following areas:
Standardization and
Quality Control
If organ sharing between centers is
to succeed, there must be assurances that
all members are equally capable of pro-
curing, preserving, tissue typing, and
transporting organs. Each cooperating
institution must be certified in these areas
prior to membership. High standards are
maintained by annual workshops, con-
tinuous monitoring, and by the sharing
of information and expertise.
Members work cooperatively to
develop new, more efficient and cost
effective procedures in all areas of organ
procurement, recipient selection and
transportation.
Meetings are held three times a year
at different member institutions so that
members can become more familiar with
each institution's facilities and personnel.
These meetings are open to all interested
persons.
The UNITED NETWORK
for ORGAN SHARING
SEOPF has been a pioneer in the
development and implementation of
computerized programs for the registra-
tion of potential organ recipients and
donor-recipient matching.
Each SEOPF member has a terminal
which links it to the central computer
housed at SEOPF's headquarters. This ter-
minal can be used to update the RECIPI-
ENT REGISTRY at any time. Whenever a
kidney becomes available, donor infor-
mation is entered into the computer
where the MATCH PROGRAM searches
for suitable recipients, utilizing such fac-
tors as histocompatibility, patients' medi-
cal status, and geographic distribution of
recipients.
In 1976, at the request of several
non-SEOPF members, the Foundation
released this computerized program for
use by any transplant center wishing to
utilize its services. The result was the crea-
tion of the United Network for Organ
Sharing (UNOS). Today, UNOS serves as
the registry and matching program for
nearly the entire United States, with a
recipient pool of over 5,000 patients.
187
rd approval and adoption. The committees oversee activities
The Kidney Center
One half of all kidneys transplanted
in the United States are shared between
centers locally, regionally, and interre-
gionally
In July 1982, SEOPF created the Kid-
ney Center. The goals of the Kidney Cen-
ter are to:
• decrease the cost of transporting
shared kidneys,
• decrease the discard rate of shared
kidneys,
• increase the utilization of shared
kidneys.
With headguarters in Richmond, Vir-
ginia, the Kidney Center is manned 24
hours a day, every day, to help transplant
centers arrange for the most time effec-
tive and cost effective means of trans-
porting kidneys.
Utilizing the in-house computer sys-
tem, the Kidney Center personnel can
provide local transplant centers with
backup and assist in the placement of
organs.
Education
One of SEOPF's major roles has been
in the area of education. The Foundation
educates its members through an ongo-
ing program of seminars and workshops.
The Foundation also uses its pooled
financial resources and expertise to cre-
ate educational materials for the public,
the professional community, and the
transplant patient.
Each year SEOPF produces booklets,
manuals, exhibits, radio, television and
print advertising, films, and other audio-
visual materials to increase awareness
and understanding of organ donation
and transplantation. SEOPF-developed
media is currently being used by trans-
plant programs throughout the United
States and abroad.
188
ffou
oundation activities
Data Collection and Analysis Fiscal Management
SEOPF's computerized system has
provided its members with a powerful
data base for retrospective and prospec-
tive studies of many factors which affect
transplantation. This data base includes
extensive information on all kidneys pro-
cured since 1977. Information derived
from these studies is shared with the medi-
cal community through many papers pub-
lished in leading scientific journals. The
data is also used to improve the computer
system, evaluate procedures, and recently,
to develop predictive models for aiding in
the selection of recipients.
In 1973 the federal government ex-
tended Medicare coverage to nearly all
patients with End-Stage-Renal Disease to
include the costs for dialysis and trans-
plantation. Under the program, institu-
tions procuring kidneys can be reim-
bursed for costs associated with the
recovery process. SEOPF administers all
billing for kidney acquisition charges
when kidneys are shared by its members
within or outside the SEOPF network.
HACK ROW
iONEVS PBOCUF
UlRF&fi I
189
South-Eastern
Organ Procurement
Foundation
Member Institutions
Alabama
University of Alabama Medical Center,
Birmingham
District of Columbia
Georgetown University Hospital,
Washington
George Washington University Medical
Center, Washington
Howard University, Washington
Army-Navy Transplant Service/Walter
Reed Army Medical Center,
Washington
Washington Hospital Center,
Washington
Florida
Florida Hospital, Orlando
University of Miami School of Medicine/
Miami Veterans Administration
Hospital, Miami
University of Florida College of
Medicine, Gainesville
University of South Florida/Tampa
General Hospital, Tampa
Georgia
Atlanta Regional Nephrology Center/
Grady Memorial Hospital, Atlanta
Medical College of Georgia, Augusta
Indiana
Indiana University Medical Center,
Indianapolis
Methodist Hospital, Indianapolis
Kentucky
Jewish Hospital, Louisville
University of Kentucky, Lexington
Louisiana
Louisiana State University, Shreveport
Tulane Medical Center, New Orleans
Maryland
Baltimore City Hospital, Baltimore
The Johns Hopkins Hospital, Baltimore
University of Maryland Hospital,
Baltimore
Mississippi
University of Mississippi Medical Center,
Jackson
New Jersey
Newark Beth Israel Medical Center/New
Jersey College of Medicine and
Dentistry, Newark
Our Lady of Lourdes Hospital, Camden
Saint Barnabas Medical Center,
Livingston
North Carolina
Bowman Gray School of Medicine,
Winston-Salem
Charlotte Memorial Hospital and
Medical Center, Charlotte
Duke University Medical Center,
Durham
The North Carolina Memorial Hospital,
Chapel Hill
Ohio
University of Cincinnati Medical Center,
Cincinnati
Pennsylvania
University of Pittsburgh, Pittsburgh
Puerto Rico
San Juan Veterans Administration
Hospital, San Juan
South Carolina
Medical University of South Carolina,
Charleston
Tennessee
University of Tennessee, Memphis
Vanderbilt University/Nashville
Veterans Administration Hospital,
Nashville
Virginia
Medical Center Hospital/Eastern
Virginia Medical School, Norfolk
University of Virginia Medical Center,
Charlottesville
Virginia Commonwealth University,
Medical College of Virginia/McGuire
Veterans Administration Hospital,
Richmond
23-029 o
83
13
190
Mr. Gore. Congresswoman Schneider, would you introduce our
final witness?
Mrs. Schneider. I am more than happy to introduce Mr. Cole-
man, who is a constituent of mine, and I must say that I am very
honored to introduce him to us today because he will tell us the
true-life story of what was involved in having his best friend expe-
rience— have his child experience the need for a liver transplant
and how he with a very cool, calm head reacted in a time of crisis.
I think this probably comes from his training as a policeman;
how he organized as a citizen activist the solution toward solving
this problem.
As I mentioned a little earlier today, because of his efforts and
the efforts of many others, Justine Pinheiro is currently being op-
erated on in Pittsburgh, and that is who Dr. Starzl was operating
on last night.
So as we sit here we are hopeful that her condition will be on the
upswing.
I might also mention that Justine's mother was most anxious to
appear here today, but fortunately she is with her daughter. Also,
there is in the audience a member of the board of directors for the
Donor Alert Program that Mr. Coleman founded. His name is Al
Skorupa.
I am delighted to have Mr. Coleman here today to tell us his
story of frustration and success. Thank you.
Mr. Coleman. It was really short notice for me, as you probably
know, and then with Monday, Justine getting notified— you will
have to excuse my written testimony. I would like to read this to
you.
My name is Raymond Coleman. I am a welding supervisor for
General Dynamics, Electric Boat Division, and founding president
of Donor Alert, Inc., a nonprofit organization founded in December
1982.
I became involved in organ procurement out of a desire to help a
friend, Jose Pinheiro, whose daughter, Justine, hopefully not any-
more, suffers from biliary atresia. This friend had been led to be-
lieve that if he made the public aware of his problem, he might in-
crease his daughter's chances of getting a liver.
When he and I became frustrated in our efforts, I went to Mr.
William Bennett, my general manager, for assistance. I felt that
being a large corporation and dealing with the media they would
know better than I how to approach the problem.
Not only did they lend their expertise to the problem of aware-
ness, they agreed to pay for Justine's operation. Members of their
staff worked tirelessly with me asking for no recognition and were
happy with the thought that through their efforts they may help
save lives.
This is the same reason that I am involved. All my efforts have
been voluntary. I and the others involved receive no pay and have
nothing to gain by my speaking here.
Our thoughts in starting Donor Alert were that if we went on a
national scale by public awareness and education and establishing
191
an 800 telephone number, and by using Justine and a representa-
tive of all people in need of transplant surgery, it would be possible
to locate enough organs to reduce the waiting list, thus insuring
Justine s survival and continuing the donor process.
Being an ex-policeman and having been involved in situations
that met the criteria of potential donors, we decided to start our
campaign with police departments. The criteria of being brain dead
and on life support was not a normal condition of dying and the
fact that auto accidents, violent crimes, child abuse and drug abuse
was a major cause of this condition, made us believe that the police
could be a big help.
We sent out on a national teletype a message that if they were
involved in these situations, to please notify the hotline and we
would notify local donor coordinators. Simultaneously with this
message, ABC World News Tonight televised our efforts on nation-
al TV.
moinCe the incePtion of Donor Alert's 800 hot line on January 13,
1983, we have received over a thousand calls, have established
chapters in six States, have registered hundreds of donors and have
come to realize that besides the basic complexities of the area of
procurement, it is frought with problems.
Some of the problems we as layman have encountered include:
first, on the whole, the general public knows nothing of what is in-
volved in organ transplants, what is necessary to become an organ
donor, or how to become one, or what to do if they want to donate
organs.
Second, although the entire organ donor procurement recipient
transplant system is run, directed and controlled by medical profes-
sionals, and for the most part it should be, I have been told I have
no right or business to be involved in organ procurement because
we are layman.
Coordinators have advised me that there is such a delicate bal-
ance between them and the medical profession that a "bumbling,
unprofessional might spoil" what they have achieved.
Our thoughts as bumbling unprofessionals is that if, instead of
the almost secretive way they approached us, that they educate the
people, that transplants affect most of the laymen. This way the
medical aspects would not be a problem.
If a doctor was told by his patients that they accepted it and
wished to be a donor, then if the opportunity to be a donor arose,
the doctor, as a normal part of handling the situation, would offer
this life-saving option to the next of kin.
This is not entirely the coordinator's fault. I have been told of
cases of coordinators being called vultures and chased out of hospi-
tal rooms for their efforts. They have been accused of preying on
the dead. J &
This exists probably because a doctor feels that his first duty is
to his patient. With proper education of the public and the medical
profession, it is hoped that once a person reaches a state of being
legally brain dead, then again, as a normal consideration, a doctor
would suggest or discuss the options and possibilities of lifesaving
organ donations.
As you are aware, it appears that every State, in some cases,
counties, cities, and regional areas, have organizations, some
192
public, some private, some sponsored, involved in some sort of
organ procurement.
These people work so hard in setting up their areas in different
parts of procurement, such as eyes, kidneys, hearts and livers, that
they feel it is their domain and seem to protect it with a vengence.
This not only occurs because of territorial protection, but ex-
treme examples have been related to me of organs that have not
been routed to an area because of personal conflicts.
When cur national hot line was set up, it was in the hopes of
coordinating these efforts. Professional or unprofessional, without
the layman there would be no organs. With the tremendous ad-
vance in the medical procedures used in organ transplants and
with the fantastic success that has been attained in liver trans-
plants, I think that the time has come for a national computer net-
work to be established which lists all patients awaiting transplants.
If this could be accomplished, then when a donor was located, the
information could be fed into the computer and a match done
making the selection impersonal and guaranteeing the most criti-
cal and best match would receive the organ.
This would make the information available to all medical person-
nel on a national basis. This should enhance the availabilitiy of
organs and success rate even more.
If this is not done in an impartial manner, it could take years for
all separate factions in organ procurement to become cohesive.
I have yet to talk to anyone involved in organ procurement who
doesn't speak of his area in a protective way, and rightly so, be-
cause of the hard work necessary to develop it, but this attitude
has to be shed now that organ transplants are growing at such a
rapid rate.
Among the first calls we received on the hot line were people
from NATCO and SEOPF. They stated that this was something
that should have been done years ago.
NATCO stated that they would like to work with us on the hot
line and invited us to Richmond, Va., to meet with members of
their board. The discussions we had further strengthened my belief
that a neutral party is needed if a national computer network was
to be set up.
There is no room for any conflict when a human life is involved.
One subject that all parties agreed on was that national programs
of public awareness and education were necessary and the time
had passed when they should have been implemented.
Following the establishment of our national hot line, several
other organizations have established them. It was felt that a lot of
money would be needed to accomplish this, so it would be some-
thing to work on in the future.
We felt that it could be accomplished now and we proved it.
Granted, to be as effective as we should be, we still need funding,
but if the Government never gave us a penny, we would still con-
tinue to grow because we are driven by a desire to help these beau-
tiful children and will not be stopped by any obstacle.
If there is Federal money available, the Government should get
behind an educational program that has already been established
rather than putting money into duplicating the efforts of caring
people who volunteer their time in an effort to help.
193
It is my understanding in some areas of transplant there is still
a shortage of organs, but in liver transplants there are more
organs than doctors to perform the surgery. Statistics show that
the success rate in liver transplants has passed the trial and error
stage and should be classified as a therapeutic and lifesaving proce-
dure.
Without Government approval of this operation, hospitals and
surgeons will not become involved and everyone's efforts will be in
vain.
My final statement to you is our experience has shown that once
people are made aware, they are willing to donate their organs in
order that others may live. In our short existence we have acquired
hundreds, approaching a thousand signed donor cards.
This has come about through what little exposure we were able
to get. The next and probably greatest problem that exists with all
cards and donors is that upon death, rarely is anyone sure of who
they should call and, further, rarely does anyone check for donor
cards.
A number of people who signed our donor cards were already
carrying some sort of a local card, whether it was for kidneys, eyes,
hearts, lungs or livers.
These people stated that they felt our national education efforts
would enhance the chance of the card being looked for and an 800
number to call would enhance the availability of organs.
At one of our functions— a story was related to me of a woman's
mother who before she died expressed a desire to donate her eyes
so that another might see. Because no one knew who to call, the
eyes were never donated.
Stories like this have been told to me time after time. It isn't just
the man in the street who doesn't know what to do, this also
extend to some doctors in hospitals. For example, on March 3, we
received a call from a hospital in Colorado with a potential donor.
Luckily, they were aware of our 800 number and contacted us.
We notified a donor coordinator, the liver was matched with a
child in California.
What is needed is not 800 different 800 numbers, but 1 central
800 number that everyone is aware of and able to call for educa-
tl0r?i?- information or to either register as a donor or donate.
This would not infringe on the medical aspects of transplant or
local and regional efforts, as a local coordinator would immediately
be notified.
This concludes my remarks.
„Jr' G?RE- Now, let me get this straight. We have two different
800 numbers. Is that correct?
Mr. Denny. The 800 number established by the North American
Transplant Coordinators Organization, 800-24-DONOR, has been
established for the specific purpose, Chairman Gore, of providing
information and referral services to physicians and nurses within
the country.
It is staffed 24 hours a day by trained organ procurement profes-
sionals who are totally familiar with the identity of doners, the
management of donor organ function, the psychological aspect of
organ donation, the surgical recovery of the organs, and the net-
work of regional programs throughout this Nation.
194
This 800 number, we hope, if made available to the physicians
and nurses in the country, will enhance the opportunity for the re-
covery of organs.
We don't seek to compete with any other organization. We seek,
however, to exercise our competence in terms of providing the
health care professionals with the information that they need.
Mrs. Schneider. Would the chairman yield a moment?
Mr. Gore. Yes; delighted.
Mrs. Schneider. Is there any particular criteria — you refer to
organ transplant professionals, is there some specific type of train-
ing or criteria that is followed in order to be acknowledged as a
transplant professional?
Mr. Denny. When I say transplant professionals, that is a gener-
ic term meaning the physicians, the surgeons, the transplant, or
organ procurement coordinators. I think you refer especially to the
organ procurement coordinators.
Mrs. Schneider. Yes.
Mr. Denny. Those of us like myself who operate organ procure-
ment programs and are available to do all of the necessary work in
evaluating the donors and making the process work.
Mrs. Schneider. What I am trying to get at is whether or not we
can see a new area of professionalism.
Mr. Denny. There is a new area of competence
Mrs. Schneider. Is there a recognized curriculum that one would
take in going to school or the university or postgraduate studies?
Mr. Denny. No; most organ procurement coordinators are either
nurses or physician's assistants. Some of us are neither. Some of us
have no background in medicine.
Mrs. Schneider. But are you certified? Is there a certification
program?
Mr. Denny. There is not yet a certification program, though I
am sure that we will be moving in that direction. The North
American Transplant Coordinators Organization does provide an
intensive, annual educational program for organ procurement coor-
dinators at the 110 programs in this country.
Mrs. Schneider. Thank you, Mr. Chairman.
Mr. Gore. Then, what differentiates you from Mr. Coleman is
your experience at it?
Mr. Denny. Knowledge, experience, and the fact that we are in
the hospitals, that we are involved with the donors in the intensive
care units, that we sit down and approach the grieving families to
offer them the opportunity for life. His effort is, I think, primarily,
and appropriately primarily designed to educate the public.
I have no quarrel with that at all. I think that it can be a valua-
ble service.
Mr. Gore. Well, Mr. Coleman, you see it a little bit differently,
don't you?
Mr. Coleman. First of all, I am not here to compete with the
medical aspects of it. I bow to his expertise, as far as that is con-
cerned.
My opinion is that my line can be just as — we both — I think both
lines are needed. OK?
That he has done it this way, I don't think was very — how can I
say it? — fair. If he would have let me know, I would have worked
195
with him to make two different lines, one for general information
and one for medical.
I would have referred all my calls. I have 35 calls on my desk of
doctors, nurses, emergency room personnel that want to know
what to do. If I knew that this was what they were doing, I would
have just given them his 800 number and done it that way.
I think that there is room for both in this field. The general
public needs, I think, the general public to tell it because they
don t understand sometimes.
If somebody came up to me and said, will you donate your kid-
neys, I would say, no, I probably wouldn't. Right? But if somebody
showed me why it was necessary, and if somebody showed me why
it was necessary to donate my liver, then I sure would.
I carry a donor card, and I have been close to it, and I think if
you put it to the people that way, people would understand and
they would donate their organs, and there wouldn't be some of the
problems that we have today.
xt ?fc, J-£NNY- May l mention something with regard to the
NATCO 24-DONOR number?
Let me describe to you something in a hypothetical situation
something of how the process works. A patient— this will be brief—
a patient involved in an automobile accident, strikes his head
against the windshield.
He is brought into the hospital. He is bleeding profusely. His
blood pressure is dropping down to the danger level where his
heart function is compromised.
His oxygenation is impaired because his breathing is slowing
down. He needs to be put on a ventilator to support the oxygen-
ation of his blood, to sustain the viability of the organs.
A doctor recognizes this patient as a probable victim of brain
death He is moving in that direction rapidly. It is a question of
should the family be asked, should the family be approached,
should they be offered the chance to think about donation?
u unueds to talk witn someb<>dy immediately. Not only about
should he talk with the family at that point, he needs to talk with
somebody rapidly about what to do to sustain the vital organ func-
tion.
In dealing with victims of brain death, there are a number of
physiological problems that occur that are not common to those of
us who are living. Maintaining the organ function in somebody
who is a victim of brain death is always a race against the clock.
It is always a competition between nature and those of us in
transplantation whether or not the organs will be recovered in
time. A physician who calls an 800 number needs to talk to a pro-
fessional immediately who knows what to do to stabilize the blood
pressure, to maintain the oxygenation, to assess when and how to
talk with the family, to determine who is a suitable prospective
donor.
r»™™eeds [t raPidly- The fact that our 800 number, 800-24-
DONOR, is manned by trained procurement professionals, is a vital
service to the physicians and nurses in this country.
Mr. Gore. Well, I think I see the two points of view represented
here. You just think that Mr. Coleman's group is not qualified to
perform the function that you wish to perform.
196
Mr. Denny. Mr. Coleman and I have spoken over the phone
about this on a number of occasions, and we had breakfast this
morning together.
We concur in having the same shared sense of urgency. We
concur in the sad realization that few of the available organs are,
in fact, recovered.
Our concern, the professional organ procurement coordinator's
concern is that the professionals be educated — I think Mr. Cole-
man's primary concern is that the Nation be educated, the public
be educated.
Mr. Gore. And he faults the professionals for failing to do that.
Mr. Denny. Perhaps not without some justification. I think that
we can do a better job. It is a question of money. I have 95 hospi-
tals in a 150-mile radius of Pittsburgh to cover; approximately
15,000 beds. I don't know how many physicians and nurses.
Mr. Gore. Now, wait a second. You cover 90 hospitals in
Mr. Denny. Ninety-five hospitals.
Mr. Gore. Ninety-five hospitals in a tri-state area around Pitts-
burgh.
Mr. Denny. Right.
Mr. Gore. Now, is there a feeling on the part of somebody in
Texas, say, that if they plug into your network that is based in
Pittsburgh, then facilities in Texas are going to be disadvantaged
and patients in Texas are going to be disadvantaged relative to pa-
tients in the Pittsburgh area?
Mr. Denny. No; when I say our area, I mean the geographical
area in which we are responsible for the education of the doctors
and nurses surrounding Pittsburgh.
Mr. Gore. But you wear two hats; right?
Mr. Denny. The rest of the country is broken up into similar
geographic areas. We wear the second hat in the sense that we
share organs with other programs similar to ours.
Mr. Gore. Aren't some of those people that are wearing two hats
in the rest of the country skeptical of your national group because
it is collocated with your regional group?
Mr. Denny. No, sir, it is not collocated with our regional group.
It is, in fact, at this time manned by the coordinators at the Uni-
versity of Pittsburgh.
Mr. Gore. They are both in Pittsburgh.
Mr. Denny. This function will be taken over within the coming 6
months by another group.
Let me explain, Congressman Gore. No; it is an information and
referral service. If this hypothetical emergency room physician
calls 800-24-DONOR, his burning, urgent questions will be an-
swered, and then he will be immediately put in touch with the
organ procurement professionals at his regional group.
If he is in Amarillo, Tex., we will put him in touch with the pro-
curement people in San Antonio.
Mr. Gore. Maybe I heard you wrong, didn't you say in your testi-
mony that there are 110 procurement groups around the country?
Mr. Denny. Yes, sir.
Mr. Gore. Didn't you say that only 50 of them will communi-
cate
197
Mr. Denny. No, sir, I alluded to the fact that the University of
Pittsburgh has worked collaboratively with approximately 50 of
these organ-procurement programs in recovering livers and hearts
for transplantations.
Mr. Gore. I see. So, that was the other half.
Mr. Denny. We have worked with 50. There are another 60 that
we have not worked with either because geography or time con-
staints prevent us from flying to the coast, for instance.
Mr. Gore. OK. So, you are wearing your local hat when you are
talking about 50 other regions that you have cooperated with.
Mr. Denny. Yes, sir.
Mr. Gore. I see. Now, how many of the 110 procurement systems
communicate regularly with your national organization, the North
American
Mr. Denny. Almost all of them. Almost all of them make use of
the NATCO 24-Alert System. We have two systems. Don't get them
confused.
The 24-Alert System is the recorded phone message system so
that a procurement coordinator in Amarillo, Tex., can call and find
out where a patient is who needs an organ from a donor similar to
the one that is located in Amarillo. OK?
Mr. Gore. Yes.
Mr. Denny. That is the 24-Alert System. Almost everybody in
the country uses that system to find suitable recipients for availa-
ble, extra-renal organ donors.
For instance, the University of Arizona transplant team flew to
El Paso, Tex., over this past weekend and recovered a heart be-
cause the procurement people in El Paso had called 24-Alert,
learned that the University of Arizona was looking for a heart
from a donor similar to the one they had.
They, in turn, called Arizona, and the two teams got together to
recover the organs.
Mr. Gore. Dr. Pfaff, we have talked about these two 800 num-
bers, the two hotlines, and I understand the difference. Mr. Cole-
man, would you publicly recommend that a doctor call Mr. Denny's
hotline and that public citizens interested in information call
yours?
Mr. Coleman. Yes; if I had a call from a doctor, I would refer to
a local coordinator in his area, anyway.
oJ^\G^£E- That num°er> again, it is really easy to remember, is
800-24-DONOR.
Mr. Coleman, what is your 800 number?
Mr. Coleman. 800-352-7001.
Mr. Gore. 800-352-7001; right?
Mr. Coleman. Yes.
Mr. Gore. Dr. Pfaff, in addition to there being these two num-
bers, there are, I understand, two computer registries; is that cor-
rect? One, the UNOS system, and the registry operated by Dr. Ter-
asaki s group at UCLA; is that correct?
Dr. Pfaff. That is correct.
Mr. Gore. To what extent do these two computer registries over-
lap?
Dr. Pfaff. They do overlap.
Mr. Gore. They do?
198
Dr. Pfaff. Yes. UNOS membership and utilization is voluntary.
All you have to do is buy a display terminal, pay your phone bill
and pay for computer costs. In effect, it is the extension of the
SEOPFs approach.
Mr. Gore. Wait a minute. The SEOPF?
Dr. Pfaff. South-East Organ Procurement Foundation. We will
call it southeastern region. The southeastern region's technology
just expanded nationally.
Dr. Terasaki has a very large tissue typing laboratory that serves
almost all of the southern California programs. Much of their work
is unified in his laboratory or by exchange with other laboratories
that are generally located in the southwest.
There is no competition between the two. It can be complemen-
tary. My principal interest is in seeing the overall activities of our
region perhaps adopted by other regions locally and then with
inter-regional cooperation.
As you mentioned, we have our own 800 number, too.
Mr. Gore. You do? .
Dr. Pfaff. I don't know what the number is. Basically it is lor
people to call in and sign donor cards. I don't think that there is
any argument about a whole bunch of people doing some things
that may overlap. . •
The biggest message we have heard today is that the public does
not know, some professionals don't know or that they need to be
reminded over and over again, and so that there is not— it
shouldn't be thought of as competition.
I hope that there is a heck of a lot of supplementation. It took
me a long time to learn how to read.
Mr. Gore. Unfortunately, it has taken a lot longer than that to
get the awareness of the importance of organ donation.
Dr. Pfaff. We are doing a good job. For example, in our region—
I will tell you, we are outstripping our use. That isn't the total
matter, though. We are looking forward— and I agree with Mel,
again, as to what should happen with transplantation.
I say it should double in terms of kidney transplants. You have
heard that liver transplantation is going to increase in numbers.
We are going from a number of roughly a hundred a year to more
than that.
Cardiac transplantation is going from a hundred a year to more
than that, so that we need to be looking towards the future. We
need to modify our practices that we are using now. That is all. We
need some help in doing that. I think many of the things that we
have talked about we can do, the one that I can't do is to make
sure that we are getting accurate information. You can really help
us there.
Mr. Gore. There are, Mr. Denny, 35 children awaiting a liver
transplant at Pittsburgh right now; is that correct?
Mr. Denny. Yes. Approximately.
Mr. Gore. How do you assign a priority as to which one ol those
children gets a liver that becomes available, assuming that several
have tissue compatibility and the rest.
Mr. Denny. Let me explain one thing. In terms ol liver trans-
plantation, we do not look at tissue compatibility as we do in renal
transplantation. That is why Mr. Coleman's suggestion that a na-
199
tionwide computer system be established so that we could sort out
suitability for an available liver on the basis of tissue typing is not
practical.
Let me answer your question on two levels.
Mr. Gore. We have to sort it out on the basis of size, don't you?
Mr. Denny. Size and compatibility of blood type between donor
and recipient.
Mr. Gore. I see. Let's suppose that you have several that have
the same blood type compatibility and size compatibility, how do
you assign priority?
Mr. Denny. If a donor is referred to the University of Pittsburgh
and we have several people who are equally suitable for transplan-
tation, the decision is left up to the physicians. Dr. Starzl and some
of his colleagues make the decision based on the urgency of need.
All of these youngsters are going to die. Some, unhappily, will
die before others, and they should be given the priority. That, in
fact, is what is done.
Occasionally, we have to compromise. Occasionally, we have only
an hour or two advance notice that a donor is available, and we
may have a recipient who has an urgent need on the west coast
2,000 miles away, a slightly less urgent need recipient in Pitts-
burgh.
If we have only an hour or two to get that liver, we will have to,
sometimes, select the less ill child. Generally speaking, all things
being equal, we will pick the child, Dr. Starzl will pick the child,
who is most desperately in need.
In the case of the 24-Alert System, again, the telephone service is
available to organ procurement people to help them understand
where there is a need for a liver or a heart that a donor in their
area might provide.
On the 24-Alert System, if you call it, you will hear that the Uni-
versity of Pittsburgh, the University of Tennessee, Massachusetts
General Hospital, Sacramento, Calif., Davis Medical Center are all
looking for livers.
We prioritize the recipients in terms of the urgency of need. In
other words, at the University of Tennessee for the last several
days there has been recognized a very urgent need, what we call a
priority one recipient.
That was the youngster that we saw this morning. This young-
ster is identified as a priority one recipient on the 24-Alert System,
so that a calling coordinator, such as the coordinator in Virginia
who called last night, is alerted to the fact that this need is per-
haps more urgent than other needs for liver transplantation among
children of the same size and blood type elsewhere in the country.
Mr. Gore. Very good. Let's suppose we could get hospitals to put
up notice about the 800-24-DONOR number and for public infor-
mation, your number, Mr. Coleman, that might be helpful, would it
not? If emergency room physicians and critical care nurses and
hospital administrators knew about this number, then they
would—well, maybe it would make them think more often.
That is, I am sure, the intent of both of you, partly, in establish-
ing such numbers.
Dr. Pfaff. Congressman Gore, actually I think that there is an-
other solution. For example, if somebody from northern Florida
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were to call their number to find out that they should call us and
get some help, we have done a bad job. So I think that you have got
to pay heed to — literally hundreds of people are active in organ
transplantation these days, and they are scouring those hospitals.
If we aren't scouring them well, we haven't done a good job.
Have all of our programs done good jobs? No. Some are doing
great and some aren't doing so great. We need to push ourselves a
little more, too.
I should have made that point earlier. I don't think everything
flows from a single source. Just as I differ with Don regarding
making a potential recipient list available to donor hospitals in
hard copy because that list is going to get awful lengthy.
Mr. Denny. We don't differ on that.
Mr. Gore. Now, Mr. Denny, financial considerations enter into
this priority. I guess you don't even get considered for priority typi-
cally unless the financial threshold has been crossed.
Mr. Denny. The child has to be accepted for liver transplanta-
tion at that center providing
Mr. Gore. The center typically turns down patients that don't
have the ability to pay unless the mother can do what Mrs. Hall
did and get a radio station and a lot of friends to help her raise the
money from volunteer donations, poor people don't have the same
chance, do they?
Mr. Denny. It depends on what State the poor people live in. In
some States medicaid has been helpful for those who are sufficient-
ly indigent to allow them to qualify for medicaid.
Mr. Gore. In States where medicaid will not pay, then they are
out of luck.
Mr. Denny. Occasionally, families have been forced to turn to
their communities for help. We have transplanted several patients
in this group. Families having turned to their communities, having
found the generosity of the neighbors, have recovered the funds
through fundraising drives in their own areas and have been trans-
planted.
It does require that on occasion, yes.
Mr. Gore. Mr. Coleman, do you believe that the organ procure-
ment effort in the country has been impaired by competition be-
tween different organ procurement systems?
Mr. Coleman. Yes. I have heard of different situations where
that has happened. But, basically, I have to say this, they are hard
working, dedicated people.
When they started in this, it was almost considered a macabre
thing. But today people accept it and it is growing so fast that I do
believe that these personal conflicts or if somebody is mad at some-
body else or something this, should be removed somehow.
If it has to be forced upon them, removed. There shouldn't be
any type of personal conflict in something like this when it in-
volves a human life.
Mr. Gore. Mr. Coleman, I was looking at the list of organ pro-
curement programs provided to us, and I notice that many cities
around the country have more than one organ procurement system
in the city, and some have as many as five different organ procure-
ment systems or networks in the same city.
How does that work? Does that cause problems?
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201
Mr. Coleman. Again, I just go by the personal talks. The medical
people can tell you more on that.
Mr. Gore. Dr. Pfaff.
Dr. Pfaff. Really, no, it shouldn't cause problems. Are they com-
peting for the same attention? Yes. How did this ever happen?
Organ procurement is an outgrowth of transplant programs, in
the main, In some areas, people have seen advantage to coales-
cence. It is like anything else that a bunch of people do together.
There has to be not only a mesh of purpose, but very important,
a mesh of personalities and some personalities don't get along with
others.
Mr. Gore. Doesn't it make sense — I mean, if we have a situation
where we have 110 different systems around the country, as many
as 5 separate systems in the same city in some cases. We clearly
see on the horizon a dramatic upsurge in the number of transplant
procedures being performed and the demand for organs for trans-
plant. It really makes sense to have a national strategy to, if not
coalesce them all into a single system, at least devote a sufficient
amount of attention to get rid of any competition that is impairing
the procedures and make it a more sensible and rational system.
Dr. Pfaff. The competition doesn't impair the procedures. As a
matter of fact, one of the major coalescences was just a dismal fail-
ure. That really isn't the matter.
It is really the question of effort, and the attention of a number
of decisions that each of us make individually in terms of sharing
organs and increasing production, of transplantation as a whole
are all really scientific decisions in the end.
I think if all of us see the need for more organ procurement, we
will do it. If, as people have heard today, there is a shortage of pe-
diatric donors for a particular problem, biliary atresia, coordinators
are going to pay attention to that.
Physicians are going to pay attention to it. Nurses are going to
pay attention to it. They are going to hear it on the night news, I
suppose.
Mr. Gore. Well, there is clearly a need for more organ procure-
ment. I mean, there is not any doubt about that, is there?
Dr. Pfaff. Oh, I think in some areas there is doubt. In some
areas, in some organs, I mean we are talking about now three liver
programs in the country, ten cardiac programs.
Mr. Gore. We have got 35 children at this one hospital alone
that are going to die if they don't get a liver. They are waiting for
one now.
Dr. Pfaff. Thirty-five are waiting?
Mr. Denny. Yes.
Dr. Pfaff. Are on the list?
Mr. Denny. Yes.
Dr. Pfaff. That represents a very high proportion of probably
the number of individuals in the country. I think that you need to
understand that.
In other words, their need is for us nationally to provide organs
to them.
Mr. Gore. Let me conclude 1 second. I am a little unclear about
this. I am told that there can be expected to be as many as 4,000
202
people whose lives might be saved by a liver transplant in this
country compared with 5,000 kidney transplants annually.
Mr. Denny. That is a projection based on epidemiological data.
There are at least two problems in realizing the promise of liver
transplantation. Certainly the first and foremost is funding, which
we have heard today, and the second we have also heard today is
the shortage of available organs.
Liver transplantation, you have to realize, until 2 years ago had
results which did not recommend it as a therapy to be frequently
applied.
It has only been within the past 2 years that liver transplanta-
tion has achieved the status that it has achieved. So we are talking
about the future.
We are talking about something that is building dramatically. A
year ago there was only one liver transplant program in the coun-
try. Then there were two. Then there were three. Now there are
six.
By this time next year there will be another six. The number is
growing rapidly.
Mr. Gore. Dr. Starzl said that as these regional centers develop
and more patients are identified and we are able to treat more pa-
tients, that it would approach the level of 4,000 a year. I mean,
that is a lot bigger than 35.
Dr. Pfaff. Yes.
Mr. Gore. So, clearly, there is a need for
Dr. Pfaff. If it grows to that point and if that is the need and
the number of individuals with hepatic failure, clear hepatic fail-
ure, and that is not just all the hepatic diseases and not all of the
hepatic diseases that may result in death— I am getting overly
technical, but if that were to happen, clearly we are going to need
a good deal more donors, but the same is true for transplantation
of each of the other organs that you have mentioned.
Mr. Gore. Thank you for your indulgence, Congresswoman
Schneider.
Mrs. Schneider. Of course. You are the chairman, after all.
I must admit that after listening to the testimony by this partic-
ular panel, I am not at all convinced that despite the very dedi-
cated efforts of keeping the public informed and providing a public
service that it is as effective as it ought to be.
I guess to express that in more specific terms, I had asked my
staff person here, Don Rheem, to go to the telephone and call the
operator for 800 numbers and see what kind of information he
could find.
I would like to relate to you the conversation that transpired. He
called the operator and he said that "I have an organ to donate,
and I would like the toll-free number, please."
She said, "May I have the agency name?" He said, "I have no
agency name."
She then said, "Well, just a moment, I will give you the supervi-
sor."
Well, essentially the supervisor went through the same thing
and then putting on her thinking cap said, "Well, why don't you
call your local hospital."
203
I am under the impression that if I were to call my local hospital
now and ask for information on donating a particular organ, I
would probably get nowhere.
It seems to me that there is a definite need to pursue the net-
work of professional communications with the doctors and the
nurses, but also the need for the public citizen information that
would very clearly answer general questions such as if I wanted to
donate my organ, who do I go to, where do I begin?
One of the things that I am concerned about is the regional as-
pects of the problem. I would certainly hope that when it is recog-
nized that we have the interest of some very powerful professional
groups and organizations, such as the AMA, and the American
Hospital Association, we can get a great deal of public service work
accomplished by groups like the American Heart Association, the
Lung Association, and other citizens' associations that we ought to
be able to solve this problem.
Now, my great concern is that, yes, here we are in a congression-
al hearing and so we always look for solutions that are derived
from our jurisdiction, but it seems pretty clear to me that there is
little we can do on this.
Now, I wonder is there agreement by this panel with me that
there is nothing that we can specifically do?
Dr. Pfaff. My statement earlier was we had to do a hell of a lot
of it. There are a few things you can do.
You can foster good information getting back to us about current
success in dialysis and transplantation. That is a responsibility the
Federal Government assumed and has not fulfilled.
So that is one thing that you can help us with.
Mrs. Schneider. Information generation.
Dr. Pfaff. Information. You must, I think, participate in the ar-
gument about funding for these other organs.
Mrs. Schneider. That is the next topic that I would like to dis-
cuss, is the funding.
Mr. Denny. Let me mention, again, I think, Congresswoman
Schneider, that I think the Federal Government can do something
that you as a Representative and your colleagues can do some-
thing.
The fact that medicare now funds 94 percent of the kidney trans-
plants in this country and is ostensibly very eager to increase the
number of patients transplanted, argues that medicare administra-
tively should be in a position to implement c financial incentive
system for those hospitals which generate donors of kidneys.
The Health Care Finance Administration is in a position to im-
plement something like that without any legislative alteration in
the Social Security Act.
On the other hand, they are not going to do it unless they get the
pressure put on them to do it.
Dr. Pfaff. Are you suggesting a bonus system?
Mr. Denny. I am suggesting a financial incentive of some kind.
Mrs. Schneider. Such as a tax credit or a reduction in a medical
bill?
Mr Denny. For instance. I leave it to wiser minds than mine.
But hospitals, you know, are heavily dependent upon medicare.
204
Medicare is heavily dependent upon the hospitals for the recovery
of kidneys for transplantation, which is funded by the Government.
It only makes sense to me to move in a direction— the heart
strings of the hospitals are closely tied to the purse strings of the
hospitals.
Mr. Gore. Will my colleague yield?
Mrs. Schneider. Sure. .
Mr. Gore. I would hope my colleague would wait until the end ot
the 3-day hearing to make the judgment that there is nothing we
can do. I think already we have had a number of recommendations
that could be included in a list of productive actions on the part of
the Federal Government, not least among them, changing the pro-
cedures at CHAMPUS that deny approval of the transplant oper-
ations for children such as Captain Broderick's daughter.
In addition, I anticipate that we will have a list, a lengthy list ol
recommendations, many of them involving changes in Federal law,
none of them as productive as or as important as the effort to in-
crease the public's awareness of making organs available, but all of
them helpful and all of them perhaps contributing to that larger
Mrs. Schneider. Mr. Chairman, my question was specifically ad-
dressed to the 800 numbers, to the information exchange and the
two separate networks, and I don't think that there is really any-
thing that we can do on that score.
I would like to address the costs of the 800 numbers and the in-
formation exchanges that you do have. Mr. Denny, can you give us
We know now the breadth of your communications network. Can
you give us an idea of the cost of that network?
Mr. Denny. Again, I have to differentiate between the two tele-
phone systems that the North American Transplant Coordinators
Organization has in place. The 24-Alert System, the recording
system, which is updated two or three times a day to acquaint
organ procurement professionals with the need for hearts and
livers is a minimal cost.
It is not an 800 number. The caller, the organ procurement pro-
fessional who is in the donor hospital has the burden of paying lor
that cost. That is not a problem. We all have credit cards. We just
The cost of setting that up was less than $200. The cost of the
800 number that NATCO has established, annually will be— it de-
pends on the times and charges— but we expect that it will run be-
tween $6,000 and $7,000 a year.
That is merely for three lines.
Mrs. Schneider. How about for the people who are operating
those lines? I mean your overall information network, total cost, is
about how much?
Mr. Denny. The indirect cost for the time of the organ procure-
ment professionals?
Mr. Denny. I have no handle on that. Again, our system has
only been in place for 10 days. m
Mrs. Schneider. That is true. Are volunteers right now manning
those phones?
205
Mr. Denny. No, ma'am.
Mrs. Schneider. Paid professionals?
Mr. Denny. Professionals like myself, my colleagues, yes.
Mrs. Schneider. Mr. Coleman, can you give us an idea of some of
the costs of your information network?
Mr. Coleman. The line costs us, again, depending on how much
time is used, it averages $180 a month. We pay $30 a month for a
24-hour answering service. The line is manned 24 hours a day.
We pay $40 a month for an emergency beeper which I carry at
all times. That is the cost of our line, about $250 a month.
We started this whole organization with a couple hundred dollars
and a lot of effort.
Mrs. Schneider. All right. Terrific. I have no further questions,
Mr. Chairman. Thank you.
Mr. Gore. Dr. Pfaff, what effect do you expect the new prospec-
tive payment reimbursement systems to have on the organization
and function of organ procurement programs?
Dr. Pfaff. Gosh, I am not sure what diagnostic category they are
going to use. There actually is quite a range in costs from institu-
tion to institution.
I can't tell you why. In some it is very high indirect cost. In uni-
versity hospitals, they are having hard times. I think the efficien-
cies of different organizations varies rather substantially.
If everything would be to a unified cost, of course, it is going to
cause so many more problems for us than if we lump transplant
patients with people with bladder infections, there is going to be a
substantial difference between those two if they hit the same diag-
nostic related group.
I would urge, frankly, that there be some greater uniformity, and
yet the risk of creating it is to probably eliminate those groups that
are a little more costly but that are still making a major contribu-
tion.
Mr. Gore. Well, some have expressed concern about the potential
effect of the prospective reimbursement system on transplant pro-
cedures and organ procurement, in particular.
Dr. Pfaff. I would say it could have a chilling effect on those
who are economically marginal but productive.
Mr. Gore. Yes. What about the business that Dr. Starzl raised,
Mr. Denny, about the Aetna letter? This is the insurance carrier
that is responsible for the Federal kidney program and apparently
it sent a letter out to institutions participating that implied that
their insurance coverage might be lost if they harvested extra-
renal organs in addition to kidneys. Are you familiar with that?
Mr. Denny. Yes, sir.
Mr. Gore. Did that have a chilling effect?
Mr. Denny. I have no direct evidence that it did.
Mr. Gore. Dr. Pfaff?
Dr. Pfaff. Well, it creates an impediment. I guess, quite honest-
ly, there is no way to measure because we don't have accurate data
on the potential utilization of multiple donor organs and, you
know, what is being done today.
In other words, our performance record isn't defined as yet. Fur-
ther, there are a good number of programs that are just getting
into multiple organ donations.
206
The bottom line is this. Actually, that Aetna did advise us that
the cost that related to procurement of other than kidneys could
not be attributed to the renal medicare program.
We have followed that, but have done it by a variety of means.
We have participated in the harvesting of both livers and hearts
and have a very active program in terms of joints that we are
doing with the orthopedic groups up and down the east coast.
In many instances we have some sources of funds. Truthfully, in
dealing with the University of Pittsburgh our costs that particular-
ly related to liver removal for the purposes of transplantation were
then passed back to Pittsburgh.
Heart donor costs were segregated to the point that we could and
then were sent to the recipient institution. I don't know what the
payment rate has been, but I suspect after all the conversation that
I have heard these last several days that, indeed, because dollars
are such an impediment to individuals who require that kind of
management, that one of the first things that the recipient institu-
tion has been paying attention to is, indeed, the donor institutions.
Mr. Denny. I think that we have to be careful and not imply
that Aetna is at fault for this. Aetna is merely operating under the
guidelines established by the Health Care Finance Administration
following the legislation which was enacted in 1973 and subse-
quently.
Aetna is responsible as the intermediary between HCFA and the
independent organ procurement programs to see to it that the reg-
ulations governing the financial aspects of organ procurement are
adhered to.
Their statement to us that we would not be covered by medicare
in the event of malpractice, for instance, and a court case involving
malpractice surrounding organ procurement came also with the
recommendation that we take out insurance on malpractice liabili-
ty for extra-renal organ procurement.
That is, in fact, what we did do.
Mr. Gore. In other words, it emanated from the Health Care Fi-
nancing Administration through Aetna?
Mr. Denny. Yes. Aetna is merely the intermediary.
Mr. Gore. We are going to have the Health Care Financing Ad-
ministration on the third day of these hearings along with the Sur-
geon General. We will be exploring a lot of these reimbursement
questions at that time.
A couple of other real brief questions. It seems as if— and I know
this is a delicate area — it seems often desirable to maintain a po-
tential donor on life support after brain death has occurred; is that
correct, Dr. Pfaff?
Dr. Pfaff. That it is desirable? It is for the purposes of multiple
organ removal in that, let's say, if somebody is coming from a
heart transplanting hospital to our institution, it might have a de-
laying factor, usually in a mattter of hours, not more than that.
Mr. Gore. But you don't get into a conflict on who pays for the
cost of care under those circumstances?
Dr. Pfaff. No. No. Well, for the purpose of the kidney donor,
from the time of the diagnosis of death, the renal medicare pro-
gram assumes the cost of continued care. But that is not for long
207
because these are unstable individuals in many instances. We are
anxious to proceed.
Mr. Gore. But if the extra care is principally needed for the mul-
tiple organ
Dr. Pfaff. We are still talking about hours.
Mr. Gore. But is it charged to the kidney program?
Dr. Pfaff. Quite honestly, I am not sure. I could imagine that
potentially being a point of confusion at the time and to the billing
personnel. I would guess that the receiving institution would
assume at least part of those costs or the fair share of costs.
Mr. Denny. Yes, sir. That, in fact, is what happens. We regularly
pay for a liver anywhere between $1,000 and $3,000, sometimes as
high as $4,000 of the share of the donor-related charges, the bal-
ance being picked up by the renal programs.
Mr. Gore. Let me note that in tomorrow's hearing we are going
to lead off with the perspective beneficiaries and voluntary agen-
cies, including Charles and Marilyn Fiske, the parents of Jamie
Fiske, who will also be with us tomorrow.
In the second panel we are going to explore indepth the bioethi-
cal considerations with a number of bioethicists, including the Ex-
ecutive Director of the Presidential Commission on Bioethics.
Then we are going to look in the third panel closely at the legal
considerations, and you got into this a little bit in your testimony,
Mr. Denny, and I would say for the record to my colleague from
Illinois that the counsel for the National Conference of Commis-
sioners on Uniform State Laws will be among the witnesses on that
third panel.
Then the third day of the hearings will be a little later on, but I
wanted to close by thanking members of this panel particularly for
your contribution here today, and to all of the witnesses who have
helped us in this first day of the hearings, I want to express our
thanks and appreciation and with that, the hearing will stand ad-
journed.
Dr. Pfaff. Thank you.
[Whereupon, at 2:45 p.m. the hearing was adjourned, to be recon-
vened the following day, Thursday, April 14, 1983, at 9:30 a.m.]
ORGAN TRANSPLANTS
THURSDAY, APRIL 14, 1983
House of Representatives,
Committee on Science and Technology,
Subcommittee on Investigations and Oversight,
Washington, D.C.
The subcommittee met, pursuant to other business, at 9:35 a.m.,
in room 2325, Rayburn House Office Building, Hon. Albert Gore,
Jr. (chairman of the subcommittee) presiding.
Mr. Gore. The subcommittee will come to order.
I would like to welcome all of our witnesses and guests for the
second day of these 3 days of hearings on organ transplants.
Yesterday was both moving and disturbing. We were all excited
and filled with joy to hear about Brandon Hall receiving a liver for
transplantation. The latest reports from Memphis are that he is
doing fine. As all patients after such surgery, he is in a critical con-
dition but is doing quite well. We are all very optimistic and pray-
erful for his speedy recovery.
Yesterday's hearing also had some very disturbing testimony,
however. The testimony from Captain Broderick, as well as others,
told of people who may die, children who may die, not because the
necessary medical technology is unavailable, nor because a trans-
plantable organ is unavailable in some cases, but solely because the
patient cannot pay for the procedures.
The third-party payers don't pay for such transplant surgery,
either. In fact, I found it to be quite shocking that the U.S. Govern-
ment would not take care of active-duty members of the U.S. Army
and the other services by providing for transplants for family mem-
bers because, in the judgment of the Department of Defense, it was
too expensive.
I think that policy has to be changed. Without objection, the sub-
committee will proceed with the plan that we discussed yesterday,
to contact the Department of Defense and the appropriate agency
within the Department of Defense, to ask for an immediate change
in that policy.
We also learned yesterday that transplant surgery is at the dawn
of a brand new era. In part, this is because of the advent of a mar-
velous new drug, cyclosporin, which holds great promise as a
means of selectively preventing rejection of transplanted organs by
the body's immune system.
It also has a great deal to do with the increasing skill and knowl-
edge in the medical community, of course. However, we also
learned that we are not likely to have sufficient organs to meet the
(209)
210
demands generated by these impressive advances in medical tech-
nology.
Nothing better illustrates what we are here for today, though,
than our first panel of witnesses. It includes little Jamie Fiske and
her parents, who, more than any single case, have come to symbol-
ize the hopes and the despair of many American families who have
children like Jamie, who were born with incurable liver disease.
It is estimated that 1 in 20,000 children are born with Jamie's
condition, biliary atresia, a condition in which the liver lacks the
ability to excrete waste products. Two of these children were with
us at yesterday's hearing.
In fact, I say two, two were at the witness table, but there were
others in the audience who came with their parents after learning
about the hearing, and I believe there are some others in the hear-
ing room today. We welcome you and hope these hearings will be
of some benefit in the effort to find a solution to the problems that
you are experiencing. For most of these children, only a liver trans-
plant offers any prospect of survival beyond infancy.
Jamie's father, who is with us, felt compelled to mount a nation-
al media-assisted campaign to secure a liver for his daughter. As is
quite evident, he succeeded, and Jamie was successfully transplant-
ed at the University of Minnesota in November, but only after the
Fiske family had hurdled a series of heart-rendering obstacles,
which they will describe for us this morning.
We will also hear from Michele Jones, who is the niece of our
ranking Republican, Mr. Skeen. I am going to call upon him to in-
troduce the Jones family in a moment. Michele received a kidney
transplant in February, after spending more than 2 years on dialy-
sis.
Representatives from the National Kidney Foundation and the
American Liver Foundation will relate their efforts on behalf of
waiting and past recipients.
The balance of the morning will be devoted to a careful analysis
of the bioethical and legal issues surrounding organ donation and
procurement.
How can we best satisfy the moral imperative to secure trans-
plant organs for victims of incurable disease while safeguarding
the rights and privileges of prospective donors and their families?
To help us, we have some of the most eminent bioethicists and au-
thorities in this area.
I hope we can conclude our day feeling that we have taken steps
toward understanding and removing some of the obstacles from the
path of the next Jamie Fiske.
Before calling on Congressman Moakley to introduce our first
witnesses, it is an honor to recognize the distinguished ranking
member of the subcommittee, Mr. Skeen.
Mr. Skeen. Thank you very much, Mr. Chairman.
I concur in the points that you have made in your statement,
particularly in regard to the fact that it is time for us in Govern-
ment to change the policies to suit the new and advanced degree of
technology afforded us today in common medical practice in the
United States. It is now a practice, it is not experimental, and it is
time for us to tell the insurance carriers, as well as the Federal
211
Government, that this change has been made and that they should
react accordingly.
I want to particularly thank you for the courtesies and the con-
sideration that you and the members of the staff, both majority
and minority, have shown the recipients and other witnesses that
have been here today. It has been outstanding, you are to be com-
mended, and I wanted to take a little time to do just exactly that.
I don't want to spend a lot of time on a statement, but I would
like to have the personal privilege, first of all, of introducing my
wife, who is here accompanying my niece, Michele; the gal who
does the most work keeping me up here and running the best
ranch in New Mexico. I would like for her to stand up, if she
would, please. Thank you.
It is a privilege to have Michele here. It has been 2 months since
her operation. We have tracked this problem through her lifetime.
I did not know that she was a recipient until she had actually been
in the hospital and the transplant had been made. It happened
that quickly.
I just want to say to you folks who work in this area, you are to
be commended because it has been a labor of life. For one who has
lost a member of his family because there was nothing that could
be done at that time, I want to say to you that we have come a
long way. All of you are to be commended, and you have my heart-
felt thanks for all the things that you do above and beyond what
your job calls for. It is your hearts that are involved in this process,
and I appreciate it very much.
Thank you, Mr. Chairman.
Mr. Gore. To introduce our first witnesses, I am pleased to call
upon our distinguished colleague, Congressman Joe Moakley.
STATEMENT OF HON. JOE MOAKLEY, A REPRESENTATIVE IN THE
CONGRESS FROM THE STATE OF MASSACHUSETTS
Mr. Moakley. Thank you very much, Mr. Chairman, members of
the committee.
The plight of little Jamie Fiske became known throughout this
Nation last fall when her parents went before the American Pedi-
atrics Association conference to appeal for assistance in locating a
very critically needed liver donor for Jamie.
Without the national attention received because of this unusual
request, Jamie may not have been lucky enough to locate a donor
in time to save her life. Fortunately, however, Mr. Chairman, with
the help of the medical community, the national coverage given to
her plight, and the dedication of her parents, a compatible donor
organ was found and successfully transplanted by a team of very
skilled surgeons.
To look at this healthy, happy little girl today one would not be
able to tell that just a few months ago her young life was in such
grave danger. Jamie Fiske, Mr. Chairman, I think is the best exam-
ple of the hope that exists through this extraordinary surgical pro-
cedure and also of the immense need for a nationwide network to
match organ donors with those individuals who are in desperate
need of transplants.
212
Mr. Chairman, I am very honored and very proud to present to
this committee Charles and Marilyn Fiske and, of course, their
very healthy daughter, Jamie.
Mr. Gore. Thank you, Congressman Moakley.
Charles Fiske, if you wish to begin, we are delighted to hear from
you. Please move one of those microphones over where we can hear
you better.
Mr. Fiske. Can you hear me?
Mr. Gore. We can hear fine, and if Jamie wants to squeal into
that other microphone, that will be just fine, too.
STATEMENTS OF CHARLES AND MARILYN FISKE, AND DAUGH-
TER JAMIE, LIVER TRANSPLANT PATIENT; MICHELE JONES,
KIDNEY TRANSPLANT RECIPIENT; DAVID OGDEN, M.D., PRO-
FESSOR OF MEDICINE, CHIEF, RENAL SECTION, UNIVERSITY
OF ARIZONA HEALTH SCIENCE CENTER; AND THELMA KING
THIEL, VICE CHAIRMAN AND EXECUTIVE DIRECTOR, AMERI-
CAN LIVER FOUNDATION
Mr. Fiske. Good morning, Mr. Chairman, and members of the
committee. We thank you for inviting us here this morning.
We would like to introduce ourselves. I am Charlie Fiske, this is
Marilyn, this is Jamie, and somewhere in this room is Daren, our
3-year-old son.
We would like to take a look at three issues that we faced as a
family. The first and the most pressing issue was the fact that
Jamie's health was declining. We were told that she had a rare
liver condition and unless she had a transplant within a very short
space of time, she would die.
We felt she was in a fine medical facility at the University Hos-
pital in Minnesota, receiving excellent care under Dr. Sharp and
Dr. Freese and a nursing staff and Dr. Najarian and Dr. Ascher,
but there was nothing they could do except wait for a donor organ
to be identified.
The second issue we faced was the whole issue of funding. The
problem became very apparent when we had gone to our insurance
company, Blue Cross-Blue Shield, and they had put in writing that
they would cover the cost of the surgery. Then they notified the
hospital, after we had received three letters saying they would
cover it, that they wouldn't cover it. Going back to Blue Cross-Blue
Shield to get clarification, the best they could offer us would be to
work out something privately.
At that point, because of the cost of that, we turned around and
went back and sat down with different folks, predominantly a
fellow named Kent Jones from the local Brockton Enterprise, who
had followed Jamie's story as a human interest story in the area
we live in. We went through the whole story with him.
We were able to get a hold of the speaker of the house, Mr. Tom
McGee, and explained our situation to him. He told us very care-
fully he would approach Blue Cross-Blue Shield and straighten it
out. We also went to one of the news stations in the Boston area,
channel 7, and spoke with a Mr. Tom Ellis, who took the informa-
tion.
213
Through those three men, within 24 hours, Blue Cross-Blue
Shield had decided that they would cover the entire cost of Jamie's
medical care.
That same day, on September 29, Jamie was put on the trans-
plant list in Minnesota. On top of that, the then Governor of Mas-
sachusetts, Governor King, approved medicaid approval for Jamie
for the surgery, which came through October 29.
So, those two issues — the one, the issue of declining health,
which we had no control over, and the funding issue — were behind
us, through Blue Cross-Blue Shield assuming costs for that, as well
as medicaid willingness to back it up.
The third issue that we faced was the issue of donor awareness.
The day that Jamie was put on the transplant list in Minnesota,
we were told that her vital signs, her liver size, her blood type,
would be put on a computerized network which would go out to the
midwestern and the western States, if a donor became available.
On top of that taking place, both the formal network that was
set up, individual doctors at the hospital, who had become very at-
tached to Jamie, contacted their classmates, asking them just to be
aware of the possibility of a donor being identified. So, both on the
formal and the informal level, we knew that word was going out.
The difficulty became between September 29 and the date of the
operation, November 5. There was that whole waiting period where
Jamie's health, we were told, was declining very rapidly. We could
tell from the size of her stomach, from her color, and from the peri-
odic episodes of internal bleeding that she really didn't have much
time at all.
During that period of time I was in Boston and Marilyn was in
Minnesota, taking care of Jamie on a daily basis and watching her
die. Through no fault of the medical facility there, because they
were giving her excellent care, the thing that Jamie clearly needed
was to have a donor identified and liver implanted in Jamie.
We didn't feel it was enough to go through the normal channels.
We knew that her protocol was on the computerized network. At
that point we went to the New England Organ Bank, and through
the dean of the medical school at BU, Dr. Sandson, put me in touch
with Dr. LoGerfo, who wrote to Dr. Najarian. Dr. Najarian, from
Minnesota, wrote back and said that if a donor was identified in
the New England area, the team would fly out from Minnesota to
Boston to identify that liver.
With that done, we — myself and Marilyn — took a look at which
direction we could go in. We do know that her name was on the
computer. We could call up that computer and hear again her sta-
tistics mentioned on that computer.
We contacted the AMA in Washington. They said that we should
get in touch with the American Academy of Pediatrics in Chicago,
which we did. We called them, specifically looking for the mailing
list of their 500 pediatric surgeons.
The organization represents about 24,000 pediatricians, and we
felt that 500 of those people being surgeons, predominantly neuro-
surgeons, would probably see a brain-dead child. What we were
hoping was that by that list, we could personally write letters to
those particular 500 surgeons.
214
As it turned out, their national convention was taking place at
exactly the same time, in New York City. We asked if we could ad-
dress that convention in New York City. There was a lot of hesi-
tancy from the academy, and I think rightly so, because it was
their convention and I was not a doctor.
Again, we went back to them and said that our problem was
symbolic of a lot of other children needing help, not only with
livers but with other organs. The response that we got back was
well, we will think about it, et cetera. We were not getting a clear
answer back.
So, with that, we turned around and went back to the same
people in the media who had followed Jamie through the Blue
Cross-Blue Shield incident. At that point, we went to other media
both within the Boston area and also through the national net-
works—ABC, NBC, and CBS— and just presented the problem that
we had, that we were not getting a clear answer back from the
academy.
On top of that, we sat down and looked at probably people that
could help us. We went, first of all, to Congressman Moakley's
office and asked if he could ask the academy for us. Very clearly a
response out of Congressman Moakley's office was yes, we will call
to see if we can get a clear answer.
The then Lieutenant Governor of Massachusetts, young Tom
O'Neill, clearly became involved in it. Senator Kennedy's office, we
asked them the same thing. Very clearly Senator Kennedy's office
responded. Senator Tsongas' office very clearly responded, asking
that same question. The Speaker of the House, Mr. O'Neill, very
clearly asked the academy, can this family get up in front of you.
Through a media awareness and political support, there was a
clear decision made back to allow us to speak to the academy. The
address was on the last Thursday of October, October 28. Our
appeal was basically for Jamie, and also mindful of the fact that
not only we were waiting, but many other children like her were
waiting.
A young family in Utah was sitting watching television that very
same night, on that Thursday night. They had two children, both
about a month apart from the ages of our children. Their young
son, Jess, was involved in a car accident the following Tuesday.
The family remembered that national telecast that had taken
place the previous Thursday. They had approached their doctors
and asked if it was possible that the liver of their son, Jess, if it
was compatible, there was a family, they did remember, that had
gotten up the previous Thursday.
Phone calls went from Utah to Pittsburgh. Pittsburgh identified
that there wasn't a candidate there that could benefit from it,
simply because they had done a number of operations that week.
The call then went from Pittsburgh to Minnesota, Minnesota
clearly responded, and went to Utah and retrieved the organ, the
liver of Jess Bellon. On November 5, Jamie received a new liver.
What I would like to do— we only have one copy of this, but we
will submit it for the record. It is pictures that very clearly demon-
strate the before-and-after effects of what happened from before
November 5 and what happened afterward.
215
Actually, the best example of a healthy operation and a success-
ful transplant situation is Jamie right now. When she left the hos-
pital, she was 14 pounds in December, and she is now 24% pounds,
doing very well, and doing some of the things she couldn't do when
she was so sick.
The reason for presenting all of that is that there were a number
of people involved in Jamie's situation, numbers of media people,
numbers of political people, numbers of residents of Massachusetts,
numbers of residents of Minnesota, who became directly involved
in it through telephone calling and asking and being aware.
As a result of that kind of effort, a number of things happened
that we have outlined as results. One is that right after the oper-
ation the donor family, through their social worker, Jayne Taylor,
asked if we would get in touch with them. The donor family had
initiated that process because they had heard that national tele-
cast.
We talked with them the following Tuesday and Wednesday.
Most of their conversation was spent asking how Jamie was doing.
We have had contact with them, and we feel that the Bellons of
Utah are Jamie's extended family and they share in Jamie's good
health as much as we do. They did it at one point in time, what no
other family in the United States was able to do it; that is, offer
Jamie an opportunity to live.
Beyond that, what has happened is that individual families have
called us. We could go through a list of names, everywhere from
California to Mississippi, even to the Hall family that we had
planned on meeting here today. Our feeling was hopefully we don't
meet you here for the right reasons. It was so good to see that take
place yesterday, with that transplant.
Individual families have contacted us. Strangely enough, it has
not just been families of liver patients. It has been families who
need corneas, who need bone marrow transplants, who need kid-
neys, who need other organs for transplant.
So, some of the same situations that we faced in terms of Jamie's
declining health, other families are going right now through that
same experience. We have had that kind of ongoing contact with
families, if for no other reason than to say it does work, there is a
possibility of hope.
On the State level in Massachusetts, the Governor of Massachu-
setts, Michael Dukakis, proclaimed March as Organ Donor Aware-
ness Month. We are told that on the national level there is an
effort to declare one of the months or one of the weeks as Organ
Donor Awareness Week.
Also, in Massachusetts the AMVETS, who are traditionally in-
volved with blood drives, became aware of Jamie's situation. They
set up on March 29 an organ donor awareness drive in conjunction
with their blood drive. Involved in that group were all the organ
banks in New England.
It is interesting because the McKeon post in Dorchester is the
largest AMVET post in the country. The State commander, Robert
Medairos, became involved with it and is taking that project, organ
donor awareness, to the national level at his national convention,
which is coming up I want to say in Florida within the next 2
216
months. He is taking that on as a project that AMVETS nationally
can get involved with, much like their blood drive.
It is very encouraging because that group has connections across
the country, and their willingness to do that as a volunteer organi-
zation has an impact for people not only waiting for livers, but for
other organs as well.
Finally, one of the results that has happened is there has been
an ongoing contact that we have had with the White House.
During the ordeal with Jamie, the President had written to us
twice, one a letter to us commenting on the fact that the Bellon
family did a caring and generous thing in terms of the gift of their
son's liver to Jamie, and also gave best wishes to Jamie. Also, the
President had taken the time to write Jamie a short note at Christ-
mastime, a "Dear Jamie" letter.
Since that time we have had an ongoing contact with the White
House. They have asked us to call other families, again not only
families of liver transplant patients, but bone marrow transplanta-
tions and kidney people. That kind of behind the scenes thing has
been taking place.
We raise all that because the issue for us is certainly not parti-
san. We have got local politicians involved in it, both sides of the
aisle, on the congressional level, on the senatorial level, at the
White House level. It hasn't been a partisan type of issue, it has
been an issue about caring for people, people caring for people.
So, it has been very encouraging, when you get various phone
calls, and it doesn't really make any difference which way I voted
or whether Jamie is whatever, a Democrat, Republican or Inde-
pendent. The fact is she needed life.
That kind of support has presented us with some of the deficien-
cies in the system, the three problems we faced. One, the declining
health, we had no control over. The issue of funding, there is input
into that. In Massachusetts, Blue Cross-Blue Shield did pay for it,
as well as Massachusetts medicaid.
The overriding problem is donor awareness. Why is it that we
had to go as a family to some of the lengths we did to involve all
levels of government, all levels in contact with media, phone bills
that were exorbitant, just to get word out, to have a family that
lives in Alpine, Utah, watching TV, not knowing where
Bridgewater, Mass. is, and responding accordingly? Fortunately,
that gift of life saved our daughter.
What we feel needs to take place, again based on our experience.
One is that there has to be a centralized type of organ donor
awareness institute or program, both on the regional and on the
national level. The way that would be set up would be that in each
one of the regions the specific responsibility of that program would
be organ donor awareness and public education.
The problem is that the local organ banks — and we have run this
by the New England Organ Bank, the Eye Bank, the Kidney Foun-
dation of Massachusetts, and the Massachusetts General Hospital
Bone Bank — don't have the ability to do public awareness. It is not
a reimbursable cost.
We presented the idea of them, with a separate organization,
doing organ donor awareness, and they bought it wholeheartedly.
They thought it was a good thing that they could match up with.
217
To put some teeth into it, what would be needed would be that
any hospital receiving federal money or clinic, that they institute
an organ donor awareness program within their hospital, not some-
thing very costly at all, but that they raise the issue on the hospi-
tal level.
Second, that every single medical school that receives federal
funding of any sort be required to institute organ donor awareness
seminars as a course of study within their medical school.
Third, any group that is receiving law enforcement money on the
federal level or on the local level, that in their police academies,
there be training officers to be aware to look on a driver's license
for the symbol of universal donor on the person's license.
We would encourage that to take place, again because organ
banks are not in the business of public awareness. That is the big
problem that we faced, is getting word out. We had to go through
political people, we had to go through media people to get word
out. If there was something, again, at the regional and national
level to do that. Then, I think the problem that we faced, the great-
est one we would be able to look at, would be her health. Other
organizations, like the AMVETS, have picked that up and are will-
ing to take it forward.
I think by that kind of effort the feeling of waiting, the feeling of
hopelessness that we went through as a family, at least there
would be something that we could say is in place.
The other issue that comes up, of course, is the issue of matching
up proper donors with proper recipients. That is a whole communi-
cations system that needs to be put in place, so that the proper
donor gets matched up on a needs basis. The awareness issue is the
one that we clearly have been faced with.
Marilyn, do you have anything to say?
Mrs. Fiske. I think mainly, just over the past months, that Char-
lie have shared everything that we have spoken about today. It just
involves very much the heart that has gone into this.
I think over the past months it is very difficult to share some of
the emotional kind of ends, the pressures and the strain, but in
fact it is not necessary today because we are just so elated and
thrilled to have Jamie home with us and to watch she and her
brother in action together at home.
It is the dreams, maternally and paternally, that Charlie and I
had when we were expecting Jamie and had to suppress them be-
cause there were so many medical priorities that took over. All of a
sudden we could feel ourselves starting to unwind and starting to
dream the thoughts and the hopes that we had as a family.
Since the past few months, in Minnesota, we have seen too
much, and we have been someplace, that we feel compelled, that
we have to be able to help other little children, help the adults that
we met in Minnesota.
I think, along with Charlie, our main goal and our hopes would
be to set up some kind of a national awareness program just to al-
leviate the strain, the additional strain that families have to go
through.
Our hearts and hopes are with the parents in this room of chil-
dren and the adults that may be in this room also, who are going
through similar kinds of ordeals. We also have such a hope in our
218
hearts for all of them, and we certainly hope and thank you for
inviting us here, to be able to see something come from this.
Thank you.
[The following material was submitted for the record:]
219
TESTIMONY FISKE FAMILY
Committee on Science and Technology
Sub-Committee on Investigation and Oversight
April 14, 1983 9:30 AM Rayburn Office Building Rm. 2325
OUTLINE
1. Review of Jamie Fiske's health condition.
2. Medical steps taken by University Hospital, University of Minnesota
both formal and informal.
Medical support of effort to identify potential donor for Jamie.
3. Waiting period between time of placement on transplant list and surgery.
Personal reflections and deficiencies in system.
4. Steps taken to involve New England Organ Bank, American Academy of
Pediatrics, political support and media awareness.
5. National alert through American Acedemy of Pediatric's convention and
the response of the Bellon family of Utah.
6. Results: a. Contact with donor family.
b. Problem of organ donor awareness through nationwide
contact with individuals needing transplant surgery.
c. Donor awareness Proclamations on State and Federal level.
d. John P. McKeon Post No. 146 Amvets - Organ Donor Awareness
Drive, local, State and National impact.
e. White House response.
Recommendations: To be presented at testimony on the 14th of April
Jamie Fiske Spring 1982
220
October 1982
2 weeks before transplant operation, November 5, 1982
. ',<
W '
* . >
January 1983
221
3okn V. JHcJCon Tost JVo. 146 *4>
rnvets
BLOOD DRIVE & ORGAN DONOR AWARENESS DRIVE
MARCH 29, 1983 3:00PM to 8:00PM
The Address Ceremony will be held between 3 & 4PM.
On this day the John P. McKeon Post #146 Amvets will conduct its
annual Blood Drive coordinated by the American Red Cross. In
response to Governor Dukakis's Proclamation of March as Organ
Donor Month, the Post on this same date will conduct an Organ Donor
Awareness Drive. The following groups and individuals have whole-
heartedly agreed to participate with the Post in this drive.
New England Organ Bank
New England Eye Bank
MGH Bone Bank
Shriners Burns Institute
Skin Bank
Jamie Fiske, Liver Transplant
Recipient
National Kidney Foundation of Mass.
New England Renal Network
Support Group for Parents of
Children with Liver Disease
Mr. Robert Mederios, State Amvet
Commander
For further information contact Service Officer James F. Mullin at
436-2911 between 9 & 4.
Michael J. Mylett
Commander
The Drive will take place at the Post located at 4 Hill Top Street
Dorchester.
4 HILL TOP STREET, DORlHESTER. MASS 02124 617-436 2911
23-029 O
83
15
222
Jokn V- JWcJKeon Tost JVo. 146 tdwt.
PRESS RELEASE
The John P. McKeon Post No. lU6 Amvets, the 1
in the country, in conjunction with the State
Robert Medairos and the State Department of A
an Organ Donor Awareness Drive to he held on
the annual blood drive. Present at the Drive
Chiampoli, National Amvet Executive Committee
Reardon, President of the Department of Mass.
This Drive is in response to the Proclamation
S. Dukakis declaring March as Organ Donor Mon
Awareness Drive has received the full support
Organ Bank, the National Kidney Foundation of
Eye Bank, the New England Renal Network, the
Bank of the Shriners Burns Institute and the
of Children with Liver Problems. This cooper
a clear example of community service that may
National Amvets organization and other groups
problem of organ donor awareness. The Amvets
been involved with blood drives. The McKeon
Organ 'Donor Awareness Drive will benefit thos
are currently waiting for transplant surgery.
Motor Vehicles representing the Governor will
the Post for its effort.
Jamie Fiske, liver transplant recipient, whose search for a liver
donor received national attention will be present with her family
at the Post on this day. The Fiske family is *«£*"*" *°Jne
supportive of the Amvet's willingness to respond to this genuine
health need.
argest Amvets Post
Amvet Commander
mvets has initiated
March 29th along with
will be E. Frank
member and Thelma
Amvets Auxilary.
of Governor Michael
th. This Organ Donor
of the New England
Mass., the New England
MGH Bone Bank, the Skin
Support Group of Parents
ative effort establishes
be adopted by the
that can address the
have traditionally
Post feels that this
e many patients who
The Registrar of
formally recognize
For further informat ion . call : Service Officer JgJ"2Ji1Mullln at
State Department of Amvets 727-2972
The Drive will take place at the Post located'at h Hill Top Street,
Dorchester between 3:00 and 8:00 PM. The Address Ceremony will be
held between 3:00 and U:00.
4 Hill TOP STREET, DORCHESTER. MASS. 02124 617-436-2911
223
JoL °P. Jlic^Keon 'Post JVo. 146 ^4mvets
March 29, 1983
ADDRESS CEREMONY
General Introduction Commander Michael J. Mylett
Formal Recognition to Governor Michael S. Dukakis through his
representative Registrar Alan A. Mackey
Review of Official Correspondence Commander Mylett
Brief Summations
Robert Medairos, State Amvet Commander
E. Frank Ciampoli, National Amver Executive Committee
Thelma Reardon, President Dept. of Mass. Amvets Auxilary
Benjamin A. Barnes M.D., Secretary-Director New England
Organ Bank
John Cur ley, Executive Director, National Kidney Foundation
of Massachusetts
Phillip Walters, Skin Bank Shriners Burns Institute
Jeff West, Support Group for Parents of Children with
Liver Problems
Valerie Belcher, Executive Director, New England Eye Bank
Jamie Fiske, Liver Transplant Recipient
Concluding Remarks Commander Mylett
4 HIU TOP STREET. DORCHE'.IER. MASS 02124 617-436 2911
224
Sl|? dnrnmanwealtlj nf JKaBBarljuaFttB
By His Excellency
MICHAEL S. DUKAKIS
Governor
A PROCLAMATION
1983
WHEREAS:
WHEREAS:
WHEREAS:
WHEREAS:
March has been proclaimed Organ Donor Month in the Commonwealth
of Massachusetts; and
The Registry of Motor Vehicles maintains an Organ Donor Program
and is committed to its implementation ; and
All citizens of the Commonwealth have been urged to take cognizance
of that event and participate fully in its observance; and
The John P. McKeon Post No. 146 Amvets in conjunction with State
Department of Amvets has willingly responded to that Proclamation
through the initiation of an Organ Donor Awareness Drive to include
the New England Organ Bank, New England Eye Bank, Skin Bank of the
Shriners Burns Institute, National Kidney Foundation of Massachusetts,
New Engalnd Renal Network, Support Group for Parents of Children with
Liver Disease; and
The John P. McKeon Post No. 146 Amvets and the State Department of
Amvets have fully demonstrated a commitment to educate the general
public through an Organ Donor Awareness Drive; and
The John P. McKeon Post No. 146 Amvets with the assistance of the
State Amvet Commander and his staff have demonstrated leadership and
concern for the health of the citizens of the Commonwealth and have
set an example of positive response to a genuine community need; and
The Amvets already have a commitment to community service and have
established a precedent that may be emulated on the national level
NOW, THEREFORE, I, MICHAEL S. DUKAKIS, Governor of the Commonwealth of Massachusetts,
do hereby give full recognition to the John P. McKeon Post No. 146
Amvets for its initiative and leadership in establishing an
ORGAN DONOR AWARENESS DRIVE
as a response to my Proclamation of March as Organ Donor Month.
Given at the Executive Chamber in Boston, this
twenty-fourth day of March, one thousand nine
hundred and eighty-three, and of the Independence
of bfle United States of America, the two hundred
seventh.
c.
By His Excellency the Governor
nnv a v tc
CHAEL S- DUKAKIS
I
GOD SAVE THE COMMONWEV.TH OF MASSACHUSETTS
225
DEPARTMENT OF MASSACHUSETTS
AMVETS
AMERICAN VETERANS Of WORLD WAR II, KOREA AND VIETNAM
durtand »y Ad
ol Congms
Jul, 13, 1947
ROOM 542, STATE HOUSE
BOSTON. MASSACHUSETTS 08133
T»l.phon«, 727-2972
April 5, 1983
Mr. Charles Fiske
100 Bayberry Ave.
Bridgewater, Ma. 02324
Dear Charlie:
1'
can V
of th
for s
Y
and t
persi
ved i
about
one w
his letter is to thank you, and Jamie on behalf of AMVETS (Ameri-
eterans of WW II, Korea, and Vietnam) for making AMVETS aware
e need to show people how important it is to donate a vital organ
omeone, somewhere, lying in bed waiting to be helped.
ou as a father of a loved one, have gone through this experience
orment of one closed door after another. If it was not for your
stence, and your love for Jamie, we as AMVETS would not be invol-
n such an important program of telling people throughout the counts
Organ Awareness", and hew to donate a vital organ so that some- '
ill 1 ive .
^f am^c tne State Commander was proud on March 2yth of the turnout
of AMVETS, arid people who care, and the coverage we received by the
S^p?'-^' A1S°' the fact that %t was held at the largest
AMVE1 Post in the country, the .John P. McKeon Post #146.
As a state Department, we have endorsed this as a Program in
conjunction with our Blood Drive. " '
I am a candidate for Nation.-.! Vice Commander of Programs If I
am successful in 1 his endeavor, i hope to make "Donor Awareness" a
Program on a National level .
' incerely
RAM/vi
Robert A. Medal ros,
State Commander
Department of Massachusett:
WE QoMtfkt TOGETHER NOW, LETS BtuJd TOGETHER
226
J fa v&mmenavetww 6& <Jvla4UuwtUei&
600 Wu&*f*» SSL*. 3i«to~ OS///
THOMAS H. SPIRITO
Commissioner
October 29, 1982
Mr. and Mrs. Charles E. Fiske
100 Bayberry Circle
Bridgewater, MA 02324
Dear Mr. and Mrs. Fiske:
The Department of Public Welfare is happy to inform you that based on the
information submitted on behalf of Jamie, approval is given for payment of her
medical treatment and for a liver transplant to be done at the University of
Minnesota Hospital.
Since Jamie has Blue Cross/Blue Shield coverage, all claims must first be
submitted to the private insurer. Payment to the hospital can only be made by
Massachusetts Medicaid at the rate authorized by Medicaid in Minnesota, less any
payment made by Blue Cross.
Physicians who customarily bill private patients for their services may be
reimbursed according to the Massachusetts Medicaid Fee Schedule for physicians,
less any payment made by Blue Shield.
Medicaid Provider Applications will be sent to the hospital separately.
After a provider number is obtained, complete policy and billing instructions
will be sent.
We wish Jamie a beneficial outcome of her treatment.
._£incerel,yf^
is H. Spipito
Coninissioner
THS:JK:mv
cc: Brockton CSA
John S. Najarian, M.D.
Annette Jorbin, University of Minnesota Hospital
Joan Keefe
227
Blue Cross .-;: ,
ol Massachusetts •» \"
J
100 Summer Street
Boston. MA 02106
October 1, 1982
Hospital Administrator
University Of Minnesota Hospital
420 Delaware St. S.E.
Minneapolis, MN 55455
Re: Jamie Flske - Identification No. 7324233
Dear Sir:
Hospital expenses incurred, for services related to the liver
transplantation for Jamie Fiske, will be paid for by Blue Cross.
Although the terms of our contract exclude coverage for liver
transplantations , due to the extenuating circumstances in this
particular case, we have made an exception.
All hospital billings should be directed to Blue Cross and Blue Shield
of Minnesota for processing.
I sincerely apologize for any inconvenience this may have caused you.
Philip A. Litos
Hospital Claims Department
cc: Patient Account Manager
University of Minnesota Hospital
Mr. Charles Fiske
Ms. Annette Jorbin
228
Mr. Gore. We appreciate so deeply your willingness to share
your experiences with us.
We are going to have some questions, if you can be patient with
us for a moment. Our procedure is to have the panel testify and
then come back for questions.
There is a common thread here. Michele Jones benefitted from
the same sort of elevated awareness that led to an organ for Jamie.
Mr. Skeen, would you like to introduce Michele?
Mr. Skeen. Mr. Chairman, I think that you could go on and in-
troduce her, so we can get on with the testimony, but thank you
very much.
Mr. Gore. Michele Jones was awaiting a kidney transplant when
there was a television show that highlighted the problems of organ
procurement. A young person was watching that show and made
the comment that he would like it to be known that he would have
his organs donated if there was ever a tragedy. As fate would have
it, not long afterwards there was an accident, and that is what led
to Michele's operation.
Michele, could you describe your experiences for us?
Ms. Jones. Thank you, Mr. Chairman, members.
My name is Michele Jones. I am 22. I just graduated from Lub-
bock, Tex., Texas Tech University.
My parents were told when I was 4 years old that I had abnor-
mally small kidneys. In 1972 they diagnosed this as bilateral renal
hypoplasia manifesting itself predominantly from renal or tubular
defects.
At this time, they told me that I should have no children. They
mentioned that I would go on dialysis. I had no idea what it was. I
had no idea what the transplant would include. As far as I knew, I
would go straight from the way I was living then right into a trans-
plant. I didn't know you would have to go through finding a donor
through tissue typing or anything like this.
In August of 1978 additional reviews were made, and they decid-
ed that renal disease was either hereditary or congenital, with re-
gional scarring.
My attitude on life at this time had turned very negative. At 12
years old you really don't think about having children, but it is
kind of in the back of your mind. As I grew older, the more I
thought about it, the more it was like a sword. It just got worse
and worse, until it made my attitude towards marriage and toward
life in general very, very bad, very negative. I really didn't care for
it. I didn't want anything to do with it. I didn't want to take the
chance of passing it on to my kids.
Basically, I had very bad mood swings. It affected my mental out-
look very much. In my junior year in college, my kidney really
started getting bad. My skin started turning yellow. My mental
process, I couldn't think as clearly. I had to sleep all the time, it
seemed like.
On July 1, 1981 I got kicked in the face by a horse, which had
nothing to do with my kidneys quitting. So, I was in ICU. When
the doctors came in and started cutting on my wrist to put a shunt
in, I had no idea what they were doing. I didn't know what they
were going to do when they hooked me up to a machine. I didn t
know what it was supposed to do.
229
When I finally could start talking, so I could ask them questions,
they told me what dialysis included, that it sent your blood
through a machine to purify it, to get rid of the waste products
that your kidney was supposed to get rid of and didn't.
Mentally, it was a very big adjustment, going from being able to
d0 'anything I wanted to to being restricted to twice a week going to
a dialysis center, 4 hours at a time. I had to work my school sched-
ule around it, my work schedule, life schedule. If I didn't feel good
when I got off the machine, I had to cancel anything I had planned
for after that.
Some of the side effects of dialysis were if they got you too dry
your legs would cramp. You might have nausea, headaches, dizzi-
ness. Sometimes when I was driving home after dialysis I would
have peripheral blindness. I couldn't see to the sides.
I got this feeling when I was driving down the road that I could
run over anybody and I would never feel it. It was a very strange
feeling, to know that you could do something like that. It was like I
couldn t be hurt. That was the sensation I got after dialysis some-
times.
My mental attitude improved greatly during my dialysis treat-
ment time, the years I was on it. I had a better outlook. It made
me grow up, I guess, in the sense I had to learn to adjust to many
life situations; to plan on something that had to be changed, then I
could do it more easily.
One of the problems I noticed on dialysis— not on the machine,
actually— was in traveling, you had to let a center know at least
two weeks in advance that you were going to go there. Sometimes
you couldn t get on, they didn't have room for you, they didn't take
out of state or out of town patients. Sometimes you didn't let them
know far enough ahead of time, and many times the towns didn't
have a dialysis center.
So, if I had continued on dialysis I think this would have affected
my working because if I had gone into being a sales representative,
as I was going to, this would have limited the regions I could have
traveled, the places I could have gone. I would have worked com-
pletely around this scheduling of dialysis.
Also, when I was on dialysis they used a Gortex graph in my
arm and it had clotted off three times since I had had it put in.
lh^ last time was the Monday before I got the transplant.
That was another thing. Eventually I would have run out of
places for them to put graphs or fistulas. They would have had to
go subclavian, and then I would have had to stay in the hospital.
Other than the inconvenience, I could have stayed on dialysis,
probably, except for mentally it was getting to me very much
Before the transplant, I did some living-related blood tissue
typing. We had gone through this for over six months. We were
having various problems with the center I was working with in
Dallas, getting this all worked up. They didn't tell us what to
expect on a transplant, where the kidney was going to go, or any-
thing like this.
On January 1, I did get on the cadaver list. I tried to get on there
before, but they said I could not get on the cadaver list and be
working up the family-related at the same time.
230
In January I got on the list. On February 4, they called me up
the first time and told me I had a kidney. I told them that I was
sick, I had a cold, and they would not let me have it. They said,
"We have other people that could benefit from this kidney. We will
check with them first." They went ahead and checked and found
one that was acceptable.
I would like to say, here, that kidneys like many other organs
are not that easy to come by. I was lucky. I was considered an easy
match. I had not had many blood transfusions. I had not built up
many antibodies. Many transplant patients have had blood transfu-
sions, and major operations which make it harder to match them.
I would also like to say that the emergency room doctor can
make the difference in usuable organs. A person may come in to
emergency, declared brain dead, and the doctor may not keep the
person alive. Where if the doctor had kept the person on a life sup-
port system; as they did my doner, the organs that the person
wants donated can be. A lot rests upon the emergency room doc-
tor's shoulders as to whether organs are usuable or not.
The 15-year-old boy who donated his kidney was watching
"Thursday's Child" on February 1, the week before he was legally
declared dead, and he donated both of his kidneys, which went to
Dallas, his corneas stayed in Tyler, they did use some of his skin at
a burn center, and his heart went to St. Louis.
When they called me Monday morning, I was on dialysis. They
said, "You have got a kidney. Get here as soon as you can." It took
us three hours to get to the Lubbock airport and then fly to Dallas.
Blood typing was done again. It took 4 to 6 hours for them to do
that, before they could say a definite yes or no with this kidney.
I had the surgery done at 9 o'clock in the morning, Tuesday
morning, on February 8. There were no complications. It took
about 4 hours. The doctor said I had a 78-percent acceptance rate
at that time, and it will increase as the years go on.
These are some of the side effects of some of the medicines I am
taking, which are Prednisone and Imuran. Short term, with
Prednisone you develop a moon face, your acne increases, like you
are going through being a teenager again, you gain weight, your
appetite is increased, but as the Prednisone levels are decreased,
most of these effects also decrease.
Long term, they told me that I could develop skin cancer much
easier, that whenever I did go out in the Sun I had to put a Sun
screen on; that I would have joint problems, basically hip joint
problems, that they could replace that; that I would also have the
possibility of coming up with cataracts, which they could also fix.
Mentally after this I think I have been much better. My mood
swings have completely gone. I have a much better attitude on life.
I look forward to it now. I see challenges. Because I have overcome
this much, surely nothing else could stop me.
Some of the things I have to watch after, since I have had the
transplant, is my immune system is much lower. Especially the
first month or so I watched who I was around, I stayed out of
crowds, and I kept a very good check on my temperature and
weight gain.
Something that I am going to have to watch from now on is my
blood pressure, which I take twice a day, and my temperature,
231
which I take twice a day. I check my weight every morning before I
eat.
As far as eating is concerned, while I was on dialysis I was on a
restricted diet. I was on a low potassium, no salt, high protein diet
plus liquid restriction of 500 cubic centimeters plus output. After
the transplant I was still restricted on the salt and still on high
protein. No I have to eat foods with potassium to keep up with my
body's needs. The liquid restriction is gone, now I have to drink as
much as I can, in order to keep my kidney flushed, and to keep my
output up. Basically the diet has changed a fair amount in that
now I can eat many more foods than I could before, especially
fruits.
I have to stay on my Imuran and Prednisone, as far as I know,
for life, every morning, I can't skip at all. If I do skip, the possibil-
ity of rejection goes up very quickly. Dr. Pedro Vergne, who is my
nephrologist, said if my temperature got above 100, first to call
him, and they would check to see if it wasn't a rejection before
they doctor me for anything else.
I don't anticipate having any problems. I haven't really had any.
I have been in and out of the hospital three times since the oper-
ation, but none of them were kidney-related that they could figure
out.
As far as plans for later on, I plan on getting a sales representa-
tive job with Marion Laboratories and continuing as I should, now
that I am what I consider normal.
Mr. Gore. Thank you very much, Michele. We will have some
questions for you in just a moment.
We would like to hear from the president of the National Kidney
Foundation and from the executive director of the American Liver
Foundation.
Dr. David Ogden, in addition to being president of the National
Kidney Foundation, is professor of medicine and chief of the renal
section at the University of Arizona Health Science Center.
Dr. Ogden, without objection your entire prepared statement will
be put into the record in full. We invite you to proceed. If you care
to summarize any of your statement, feel free to do so.
Dr. Ogden. Thank you, Mr. Chairman, and members of the com-
mittee.
I appreciate the opportunity to speak to this committee on behalf
of the thousands of lay and multidisciplinary professional volun-
teers of the National Kidney Foundation, which is the leading vol-
untary health organization dedicated to the needs of people with
kidney and urologic diseases.
I would comment in four areas. I should indicate that my com-
ments pertain particularly, if not entirely, to kidney disease, which
is the area in which we have particular interest and expertise.
First, the role of the National Kidney Foundation in organ pro-
curement; second, the present status compared to the potential of
organ procurement; third, the results of a recent Gallup organiza-
tion survey concerning the attitudes and opinions of the American
public toward kidney donation; and finally, measures to enhance
organ donation in the United States, as suggested by both our
Gallup survey and by the Foundation membership.
232
The National Kidney Foundation organ donor program began 15
years ago with the support of the Uniform Anatomical Gift Act.
Since then, the foundation has printed and distributed over 30 mil-
lion donor cards, including 900,000 cards which were distributed
through a cooperative effort with the Lutheran Church.
The Foundation and its more than 50 affiliates actively support-
ed the individual State driver's license organ donor checkoff laws,
which now provide for people to donate organs in all 50 States, or
to indicate their willingness to donate organs. The value of this
option in enhancing public awareness of organ donation has been
tremendous, as evidenced perhaps from the Gallup survey.
The Foundation conducts an active and ongoing program in sup-
port of kidney transplantation and organ donor publicity, both
through its own publications and through broader media. Recent
efforts include arrangements by our affiliates of numerous radio
and TV appearances and over 100 newspaper articles which de-
scribe Arnold Beher's "Gift of Life," 9,000 mile, zigzag, cross-coun-
try bicycle tour with a bicycle powered by a transplanted kidney.
It includes Foundation support of the U.S. team's participation
in the 1982 Fourth International Transplant Olympics held in
Athens, Greece, and includes the just completed organ donor blitz,
in which a number of members of Congress signed organ donor
cards and in which the President of the United States met with
National Kidney Foundation officials and endorsed the concept of
organ donation.
The present status of organ procurement can be judged from the
number of kidney transplants performed compared to the number
of kidneys that are potentially available and suitable for transplan-
tation.
In 1981 there were nearly 2 million deaths in the United States
from all causes. About 60 percent of these deaths occurred in a lo-
cation that was potentially accessible to organ procurement. We es-
timate that of those, only 1.5 percent would meet existing criteria
as potential organ donors for kidney transplantation.
I would like at this time to make the point that the criteria for
potential donation of other organs are quite different, so the fig-
ures don't really pertain to hearts, livers, or other organs.
Therefore, about 18,000 dead people might have contributed two
kidneys each, providing 36,000 potential kidneys. Of those, for var-
ious technical reasons, no more than about 75 percent, or perhaps
27,000, might be considered actually transplantable. An additional
10 percent wastage might be experienced in locating a suitable re-
cipient.
So, there might have been 24,000 kidneys available for actual
transplantation. In fact, 3,425 cadaver kidneys were transplanted
in 1981. That is about 14 percent of the potential organs available.
It is estimated that at any point in time, there are 6,000 to 8,000
U.S. dialysis patients waiting for cadaver kidney transplants.
The Gallup organization survey, commissioned by the National
Kidney Foundation, was conducted from January 14 to January 22
of this year. Of a nationally representative survey sample of almost
1,600 people age 18 and over, 93 percent had heard of organ trans-
plants and 76 percent had heard of organ donor cards. Eighty-five
233
percent of respondents were aware that organs were only some-
times or rarely available when needed.
Thus, the American public is remarkably aware of the issue and
of the problem. Perhaps more remarkably, 83 percent of those
aware of organ transplants indicated that they were very or some-
what likely to donate the kidneys of a loved one, although only 40
percent were very or somewhat likely to want their own kidneys
donated after death.
The reasons most often cited for not wanting to donate their own
kidneys were, "I never really thought about it," 20 percent of
them, and "I don't like the idea of cutting me up after I die," an-
other 20 percent.
Of those who are very or somewhat likely to donate their own
kidneys after death, 31 percent had signed a donor card. If the
sample is truly representative of the U.S. adult population, then
approximately 21 or 22 million adults have actually signed donor
cards.
It is apparent that the shortcoming in organ availability is not a
lack of public awareness or public education. It is not a lack of
public willingness to grant permission for organ donors after death.
Indirectly, then, the survey indicates that the greatest potential for
enhancing cadaver organ availability is in identifying potential ca-
daver donors and appropriately requesting consideration of organ
donation of family members.
Mr. Chairman, I am attaching a copy of an executive summary
of this survey to my testimony. I would like it to be published as
part of my testimony.
Mr. Gore. Without objection, we will include that in the record.
Dr. Ogden. The key elements of a successful organ procurement
and transplantation system include, first, surveillance by hospital
personnel; second, potential donor identification by hospital and/or
medical personnel; notification of the transplant coordinator; pre-
liminary donor evaluation; pronouncement of death by the pa-
tient's own physicians; informed consent of the next of kin ob-
tained by the transplant team; the donor surgery; donor tests, in-
cluding tissue typing; identification of potential recipients; trans-
port of the donor organ to the recipient; final recipient tests; and
finally recipient transplantation.
The Gallup survey suggested enhanced organ donation can most
likely be achieved by attention to surveillance by hospital person-
nel, identification of potential donors, notification of the transplant
coordinator, and appropriate request for informed consent from the
next of kin.
The remaining elements of the system I have described are large-
ly in place and function more or less well in every large communi-
ty in the Nation.
Therefore, the National Kidney Foundation specifically recom-
mends that the Joint Commission on Accreditation of Hospitals be
asked to require that every JCAH approved hospital of 150 beds or
more document the existing donor status from each patient's driv-
er's license at the time of admission, recording this status on the
admission form; that in the event of admission or transfer to any
intensive care unit from the emergency room or any floor of those
hospitals, the existing donor status be determined from the admis-
234
sion form and recorded on the ICU transfer form or intake form
and in the initial intensive care unit nursing note.
Compliance with these measures would be determined at the
time of JCAH review and would be a factor in JCAH approval of
the hospital's operation.
We suggest that the American Medical Association and State
medical societies be asked to encourage all physicians, through the
chairman of the medical staff, to include in any "no code" or any
"brain death" progress note a notation of potential suitability for
organ donation and acknowledgement of existing donor status as it
is recorded on the admission record; and that all physicians be en-
couraged to notify the area transplant coordinator when in his or
her professional judgment a dying patient may be a suitable trans-
plant donor, whether or not the patient had previously indicated
an intent to be an organ donor.
We recommend that all appropriate medical and voluntary
health agencies and the Department of Health and Human Serv-
ices encourage all State legislatures to enact a uniform brain death
law in those States that currently are without such legislation.
Finally, that continuing medical education be encouraged by
physicians and by professional and voluntary health organizations
concerning the identification of potential donors, concerning organ
donor procedures, and concerning the results of transplantation,
and that these continuing medical education efforts be targeted
particularly to intensive care unit nursing and physician person-
nel, emergency room nursing and physician personnel and neurolo-
gists and neurosurgeons.
I would like to thank the members of this committee for your at-
tention and for this opportunity to testify.
Mr. Gore. Thank you.
[The prepared statement of Dr. Ogden follows:]
235
April 14, 1983
Testimony of David A. Ogden, M.D., F.A.C.P.,
President, National Kidney Foundation
Mr. Chairman, Members of the Committee:
My name is David A. Ogden, President of National Kidney Foundation,
and Professor of Medicine at the University of Arizona College of Medicine.
I appreciate the opportunity to speak to this committee on behalf of the
many thousands of lay and multi-disciplinary professional volunteer members
of the Foundation, which is the leading voluntary health organization
dedicated to the needs of people witn kidney and urologic diseases.
My comments will concern four subjects:
1. The role of National Kidney Foundation in organ procurement;
2. The present status, compared to the potential, of organ
procurement ;
3. The results of a recent Gallup Organization Survey ul" the
"Attitudes and Opinions of the American Public Towards
Kidney Donations";
4. Measures to enhance organ donation in the United States as
suggested from the (Jallup Survey and by the Foundation
membership.
National Kidney Foundation Role :
The National Kidney Foundation Organ Donor Program beg. m in 1968,
witli support of the Uniform Anatomical Gift Act. Since then, the Foundation
has printed and distributed over 30,000,000 donor cards, including 900,000
cards distributed by means of a cooperative effort with the Lutheran Church,
236
in the September, 1982, issue of The Lutheran Witness, the official
periodical of the Lutheran Church - Missouri Synod. The Foundation and
its more than 50 Affiliates actively supported the individual State's
driver's license organ donor check-off laws, which now provide for
people in all 50 States to indicate their willingness to be an organ
donor. The value of this option in enhancing public awareness of organ
donation has been tremendous, as evidenced from the Gallup Survey.
The Foundation conducts an active and ongoing program in support
of kidney transplantation and organ donor publicity, through its own
publications and through broader media. Recent efforts include arrangements
by our Affiliates of numerous TV and radio appearances, and over 100
newspaper articles describing Arnold Beher's "Gift of Life" 9000 mile,
zig-zag, cross country bicycle tour with a bicycle "powered by a
transplanted kidney"; Foundation support of the U. S. Team's participation
in the 1982 IVth International Transplant Olympics held in Athens,
Greece; creation, with the generous support of the American Contract
Bridge League, of a dramatic film about kidney transplants titled
"Bridging the Gap"; sponsorship of a one and a half day Science Writers
Seminar in Washington concerned significantly with recent advances in
organ transplantation, and resulting in many newspaper articles nationwide;
and the just completed Organ Donor Blitz during which a number of members
of Congress signed organ donor cards and the President met with NKF
officials and endorsed the concept of organ donation.
237
The Foundation also met with representatives of IICKA, the liSKD
Networks, and representatives of the Emergency Medical Services (EMS)
Program to help establish a program to inform EMS staff of potential
donor characteristics, and to foster a working relationship between
EMS Coordinators and Regional Organ Retrieval teams.
Present Status of Organ Procurement :
The present status of organ procurement, based on 1981 figures
(the last year for which accurate data is available), can be judged
from the number of cadaver kidney transplants performed, compared to the
number of kidneys potentially available and suitable for transplantation.
In that year, there were 1,987,000 deaths in the U.S. from all causes,
60% of which, or 1,192,000, occurred in locations potentially accessible
for organ procurement. Only 1.5% of these people would meet existing
criteria as potential organ donors for kidney transplantation. Thus,
17,830 dead people might have contributed two kidneys each, providing
35,760 kidneys (criteria for donation of hearts and livers are dissimilar
to criteria for suitability for kidney donation, so it cannot be assumed
that similar numbers might have donated a heart or liver). Of the
35,760 kidneys potentially available, for various technical reasons,
no more than 75% or 26,820 might be considered actually transplantable.
An additional 10% wastage might be experienced in locating a suitable
recipient. Thus 24,140 kidneys might have been potentially available
for actual transplantation. In fact, 3,425 cadaver kidneys, or 14% of
this number, were actually transplanted in 1981.
238
It is estimated that at any point in time, 6,000 to 8,000 U.S.
dialysis patients are waiting for a cadaver kidney transplant. This
number might change with the improving science of and results of cadaver
transplantation, and might increase simply if cadaver organ availability
increased, shortening the waiting time for some patients and increasing
the probability of suitable tissue matching for hard-to-match patients.
The Gallup Organization Survey:
The National Kidney Foundation commissioned the Gallup Organization,
Inc. to conduct a survey of "Attitudes and Opinions of the American
Public Towards Kidney Donations" from January 14-22, 1983. Of a nationally
representative survey sample of almost 1,600 persons age 18 and over,
93% had heard of organ transplants, and 76% had heard of organ donor
cards. Eighty-five (85%) percent of respondents were aware that kidneys
were only sometimes or rarely available when needed. Thus, the American
public is remarkably aware of the issue and the problem. We would like
to think that this is reflective, in part, of the efforts of the National
Kidney Foundation to educate the public in this area.
Perhaps more remarkably, 83% of those aware of organ transplants
indicated they were very or somewhat likely to donate the kidneys of a
loved one, although only 40% were very or somewhat likely to want their
own kidneys donated after death. Reasons most often cited for not wanting
to donate their own kidneys after deatli were "I never really thought about
it" (20%), and "I don't like the idea of someone cutting me up after
239
1 die" (20%). Of those very and somewhat likely to donate their own
kidneys after death (40%), 31%, or 12.4% of the entire sample, had signed
a donor card, and 41%, or 16% of the sample, had told their family
members of their wishes. If the sample is truly representative of the
U.S. adult population, then approximately 21-22 million adults have
signed donor cards and 29 million adults have told their family members
of their wishes to donate.
A great deal more detailed information is contained in the
Survey, an Executive Summary of which is available from the National
Kidney Foundation, 2 Park Avenue, New York, NY 10016. However, from
the information above, it is apparent that the shortcoming in organ
availability is not a lack of public awareness or education, and it is
not a lack of public willingness to grant permission for donation of
organs after death. Indirectly, the Survey indicates that the greatest
potential for enhancing cadaver organ availability is in identifying
potential cadaver donors, and appropriately requesting consideration
of organ donation of family members.
Measures to Enhance Organ Donation:
Typically, factors cited as inhibiting organ donation have
included 1) lack of public awareness; 2) lack of public and professional
education; 3) failure to philosophically recognize death as a natural
part of life;. 4) the fact that 28 States do not have a "brain death"
law; and 5) the lack of a nationally coordinated organ uonor network,
including the logistic complexity of a nation,! 1 matching program.
240
The Gallup Survey suggests that although there is room for
further public education, factors 1, 2, and 3 above are not major factors
inhibiting organ donation. Certainly most medical professionals are at
least as aware of organ donation as is the general public. Education
of medical professionals concerning potential suitability of and recognition
of suitable donors for various needed organs must be on-going. Passage
of a brain death law by States not now having such a law would surely
be of some benefit in increasing organ donation, but cadaver organs are
currently obtained in States without brain death laws, and the absence
of such a law has not been shown to greatly inhibit organ donation.
Regional Organ Procurement Programs now exist in and cover virtually
all regions of the country. Increasing telephone and computer links
of these regional programs has produced a fledgling National Network.
In any event, few organs are now wasted because of failure to identify
a recipient. I am confident that, if the availability of organs
increases, the organ sharing system will adapt and expand such that
these organs will not be wasted.
The key elements of a successful organ procurement and
transplantation system include:
A. Surveillance by Hospital Personnel
B. Potential Donor Identification by Hospital and/or
Medical Personnel
C. Notification of Transplant Coordinator
D. Donor Evaluation - Preliminary
241
E. Pronouncement of Death by Patient's Physicians
F. Informed Consent of Next-of-Kin Obtained by Transplant Team
G. Donor Surgery
H. Donor Tests - Tissue Typing
I. Identification of Recipient(s)
J. Transport of Donor Organs
K. Recipient Tests - Final
L. Recipient Transplantation
The Gallup Survey indicates that family members, if identified
and asked, are likely to grant permission for organ donation. This
suggests that enhanced organ donation can most likely be achieved by
attention to surveillance by hospital personnel, identification of
potential donors, notification of the Transplant Coordinator, and
appropriate request for informed consent from the next-of-kin. The
remaining elements of the system are largely in place and functioning
well in every large community in the nation.
Therefore, the National Kidney Foundation specifically recommends:
1. That the JCAH be asked to require that:
A. Every JCAH approved hospital of 150 beds or more document
existing donor status from each patient's driver's license
at the time of admission, recording this status on the
admission form; and
B. In the event of admission or transfer to any intensive
care unit (ICU) from the emergency room or any floor
of the above hospitals, existing donor status be
ascertained from the admission form and recorded on the
ICU transfer form (intake form) and in the initial ICU
nursing note.
242
Compliance with these measures would be determined at the time
of JCAH review and would be a factor in JCAH approval of the Hospital's
operation.
2. That the AMA and State Medical Societies be asked to:
A. Encourage all physicians, through the Chairman of the
Hospital's Medical Staff, to include in any "No Code"
or "Brain Death" progress note, a notation of potential
suitability for organ donation and acknowledgement of
existing donor status as recorded on the admission
record; and
B. All physicians be encouraged, as in number 3 above, to
notify the area Transplant Coordinator, when, in his or
her professional judgement, a dying patient may be a
suitable potential transplant donor, whether or not the
patient had previously indicated an intent to be an organ
donor.
3. All appropriate medical and voluntary health agencies, and
the Department of Health and Human Services encourage all
State legislatures to enact the Uniform Brain Death Law in
those States currently without such Legislation.
4. Continuing medical education be encouraged by physicians,
professional and voluntary health organizations concerning
identification of potential donors, organ donor procedures,
and results of transplantation, and be targeted particularly
to ICU nursing and physician personnel, ER nursing and
physician personnel, neurologists and neurosurgeons.
I would like to thank the members of this committee for the
opportunity to provide this testimony.
243
ATTITUDES AND OPINIONS -OF THE AMERICAN
PU3LIC TOWARDS KIDNEY DONATION
EXECUTIVE SUMMARY
Prepared For:
THE NATIONAL KIDNEY FOUNDATION
Prepared By:
THE GALLUP ORGANIZATION, INC.
S3 Bank Street
Princeton, New Jersey, CSS^O
GO 8305
February, 1383
244
BACKGROUND AtiD ML"T!!Ot>OLCrGY
The National 'Kidney Foundation, as part of its plans for a national
education campaign on the need for kidney donations for those needing
kidney transplants, commissioned The Gallup Organization, Inc. to conduct
i- survey of the American public en attitudes towards kidney donations.
The survey was conducted by in-person interviews among a nationally
representative sample of 1,57-', persons age 18 and over. Interviewing i:as
conducted during January K through January 22, 1933.
■y/ rC'//x /? s '/'
245
T!Or.- IffiO ARfJiCRL l|m Y_T0 l.'AMT THE IK O'.n KIDNEYS D0NA1 EH f.riLl! HEATH AH!
Those who are rr.ost likeky to want their own kidneys donated after their
dc-:'th are those who have completed more foriii-il education and are in higher
inccr.e brackets (tv;o interactive variables ). Blacks are rr-uch less, likely
th;n whiter, to want their own kidneys donated (10" vs. 27:'). These sane
demographic characteristics distinguish those rare likely to give permission
for the kidneys of e loved one or their own child to be donated.
f!A?:v RESPONDENTS SAY THEY HAVE NEVER REALLY THOUGHT ABpL'T IT HiQ ASKEIi TO
~P./TI '.'/.PIOUS REASONS AS RE1N~G "VER'i IMPORTANT "
About one in five [20%) say that a \cry important reason for not wanting
to have their kidneys donated after their death is that "I never really
thought about it".
DISLIKE F0!i IDEA OF BEING CUT UP AFTER PEAT! I CITED AS "VEP.Y IMPO:-; JA! i T" KY
ONE" IN FIVE "
About the same proportion (20/:) cite as "very important", the reason
"3 don't like the idea of somebody cutting rne up after I die". No other
reason was cited by that large a proportion of respondents as being "very
important":
FF_V.' SAY THAT RELIGIOUS REASON'S OR COMPLICATED PERMISSION PP.QCED'JSES AREJvTRY
IMPCr.TANT
r.z •
Only 7" say either that the reasons "it is against :\y religion" or
: "it is complicated to give permission" are \-Q\-y inp:-: '.r.nt reasons for
wanting their own kidneys donated after their death.
246
'.--.! i':»: 'o;' iM" ir.rA or tsn.'Jr, cni up a_fjfr_natj!_ rs T!if reason which most
sV:"£:HTl7i Yi iiiiTfiAjNFs" "Tiiosi" IroIiV "Am) lesVu :~:iy T6j^i_cr..-:| k; u^eys JWjJtfTn
The greatest difference between those more and less likely to want their
o;n kid;.c-vs donated is in their response to'- -the reason: "3 don't Tike the idea
of sore'.o-.'y cutting me up after I die"'. Only l'. of these who say they are very/
scr-i'.-what likely to want their own kidneys donated characterized that reason
as being "very important", compared with tt:l of those who arc not very/not at
ell likely, more than twice the difference of each of the eight other reasons
presented .
FTV: HAVE TftSF^CJIQSS. TO LMPLEKEWT-JHlIR r;7£?ES7 IS MAV1MG TULU; QHH
Less than half (41 '<) who say they are very/son:owr.et likely to want
their own kidneys donated after their death have told family members about
their desires. Even fewer (31'') have signed an organ doner card; told close
friends (182); told a doctor (5S); or pot it in their will [£%).
A'.;*?E:iE5S OF QRGA'f CONOR CARDS IS VERY_MIGK
Seventy-six percent of those interviewed say they have heard of organ
donor cards. Even among those net likely to want their own kidneys donated,
76;: had heard of the cards; almost two-thirds of blacks interviewed (65*)
had heard of them.
A SMALL ?PGPCi.raiCH_OF_J_h!_OSE A'. I ARE OF ORGAi; LJl'h'QR CAP.DS KAVE SIGi.'ED TI'F-'-i
Only 1C2 of those aware of organ donor cards have signed one. Ever,
scong those likely to want their own kidneys donated, only 3f."-' have signed a
card.
.J/, &/fy fy,, ,;„/,<■,. ■_ Kr
247
*.
r.osT coriRt ciiv asstss cc'.'slqu^cc.^of _s_i ciiujGjWj/.rMiqiiOK _c anus
Virtual ly oil aware of organ tion'ii cards and virtually all who say they
have signed an orgun donor cord bc-licvc correctly that tha f ol low! IK] two
Statement s ore false:
"If you signed a card, soricone can force you to give up one of
your kidneys when they need one for a transplant."
"Once you have signed a card, you cannot change your mind."
VERY HIGH LEVEL OF PELIEF THAT A CENTRAL FILE OF CARD S I GNERS^ JjO ST
Almost two- tin" re's of those av?re of cards, and half of those who have
signed cards believe, erroneously, that the following statement is true:
"There is a central file of people who have signed donor cards
which is made available to doctors or others who are. trying
to locate a kidney donor."
ABOUT OME- THIRD BELIEVE THERE ARE KIDNEY BANKS. AS THERE ARE_ DLOOi) t'.AflKS
About one-third (31r>) of those aware of organ transplants believe,
erroneously, that there arc kidney banks, just as there are blood banks.
This is equally true of those more or less likely to want to -have their own
kidneys donated. Those who have signed an organ donor card are less lifcelv
( 2 3 fi ) to believe this is true.
VIRTUALLY NO ONE BELIEVES THAT DONATED KIDNEYS ARE "ALVJAYS^ ^'AILAR-I E,
"OFTE.'i" AVAILABLE, OR "NEVER" AVAILABLE
Those respondents with an opinion split about equ:.lly between holicvino
that donated kidneys are "sc::.e times" available (44:1) or "rarelv" available
(415).
z^kr S>C/'/yi C to.w;///;'-.- - . >^
248
y-',- i.;-:o h\>: LEAST L 1_KELY_ TO W/WT_THl IJ! o.<:: hi eki;^ u:a:a;i j u _a;jj ;:_mu;:
v'.';?' ;!;:[ iiu^Y"XjQ.-LL"l 1° "bL"ll"Lvt 1hiAT" Jl Ul: LLlL./jJ-k "haj'Lly" A'/aha^t '..t.e;: .
AVrj>:j[
Those v-.-iio have signed on&aji donor cards ere more likely to say that
kidneys ere "sometimes" available, rather than "rarely" available (4,7" to 39'.).
This is true, as well, among those who are very/ somewhat likely to want their
own kidneys donated (49r; say "sometimes" available; 38;. say "rarely" available).
However, among those who say they are not very/not at all likely to
want their own kidneys derated, only 36:': say that they think donated kidneys
are "sometimes" available, with 46;' saying they are "rarely" available.
•■'I-TU-u' Y :!0 C'!r SR.IEVE5 THAT KIDNEY TRAriSPLAi.'TSjlTHEFJ MAVEJ. ITT!_E 01: [:Q
tffTtTh'^Wlx'CiPirrii's life, o~». that tliEYniGHT stic;:TLii tsat plkson's life
Even among these who say they are not very/not at all likely to want
their own kidneys donated after their death, no wore than 1 or 2 percent
chose either of these two responses as characterizing the effects of kidney
donation on the person receiving a kidney transplant.
'•.:V'L BH.1EVE THAT A KIDHEY TRANSPLANT CAH "EXTEiiD THAT PtgSOri'S LIFE
Tu.~ST7-1l7lCLT~TTiA~;i TKAT~IT "MIGHT fiff Ml"G:iT NOT EXTEND ft-'AT ? L','.i~)\:'' S LIFE"
When presented with four possible effects of a kidney transplant on a
recipient, about half "of all those surveyed who are aware of transplants
chose the response: "can extend that person's life substantially", and
another 42" chose the response "might or might not extend that person's
1 i fe".
As expected, more of those who signed an organ donor card (61"), an:!
more" of those who are very/ somewhat likely to want their own kidneys donated
(60 ) chose the response: ''can extend that person's life substantially".
These who e^~e not very/not at all likely to want their own kidneys
donated are significantly less likely than others to choose the response
"can extend that person's life substantially" (40:'.), and significantly rr.orc
li'-.ely than others to choose the response "might or might not extend that
person's life" (46").
<rY C/Z/S
249
Mr. Gore. Our last witness on this panel is the executive director
of the American Liver Foundation, Mrs. Thelma King Thiel.
Mrs. Thiel, we are delighted to have us with us this morning.
Mrs. Thiel. Thank you, Mr. Chairman, members of the commit-
tee.
I am the executive director of the American Liver Foundation,
and I would like to mention that the American Liver Foundation
has only been fully operational for about 3V2 years. Typically, the
noncomplaining liver has been sadly neglected over the years.
I am also the founder of the Dean Thiel Foundation, one of the
first foundations in the country to focus on liver diseases, the
fourth leading cause of death in our Nation. My son, Dean, in
whose memory the foundation was named, would have been 17
years old today.
He was diagnosed at 2 weeks of age of having cirrhosis of the
liver from biliary atresia. Each day of his 4 years on Earth I
prayed for research to find an answer to save his life. I hoped and
prayed, but my hope was transparent. Little was known and even
less was shared with us as desperate parents.
Today there is true substance to the word hope. The replacement
of diseased organs is possible. Today we can roll away the stone of
death and give new life to babies, children, mothers, and fathers
with liver transplants.
As the mother of a child who suffered the agonies of hell for 4Vfe
years, I felt angry, cheated and crushed beyond belief to lose my
precious son. Seventeen years ago a life-saving liver transplant was
not within our grasp. Today the story is different, thank goodness.
There is hope, miraculous hope. But with that hope comes the frus-
trations and new problems.
Liver transplants can save lives if a donor of the required age
frame can be found and the liver retrieved quickly. Another if re-
lates to the money. A new liver, a renewed life is attainable, if
enough money is available to pay for this costly procedure.
The American Liver Foundation receives calls daily from desper-
ate individuals pleading for help. Where can they get the money to
save their child s life? The only answer that we can give them is to
contact your legislators, contact your insurance company, and go to
the media. We are actually telling them to go out with a tin cup
and try to pay for their child's liver transplant. I know how they
feel. Our time ran out, but their clock is still ticking.
_ In the 13 years since my son died, I have dedicated my life to
finding the answers to liver diseases. I am proud to be working
with the American Liver Foundation toward this end. We welcome
this opportunity to share our concerns with you and to help find
solutions for some of these agonizing problems.
Over the years the lower level of funding for liver research has
resulted in a severe lack of diagnostic tools to identify many of
these insidious diseases until irreparable damage has been done.
Effective treatments and cures are almost nonexistent for many
of the 100 liver diseases that attack children, as well as adults.
Most Americans know very little about their livers and how to pre-
vent liver diseases.
Liver transplantation, a last resort procedure just a few years
ago, is the only hope for survival for thousands of Americans suf-
250
fering with incurable liver diseases. The cost of a liver transplant
represents an investment in the restoration of a productive life for
victims of liver disease.
The need for more liver transplant centers and trained trans-
plant surgeons is evident. The need for donors, a current problem,
will increase dramatically in the next few months as several more
transplant units are established.
How can we possibly meet the demand for more donors? How
can we stop the incredible waste of life-giving organs, lost daily
through ignorance, indifference and perhaps fear? If physicians
and other health care providers could only feel, for just one
moment, the deep sense of anguish of a parent whose child s life is
slipping away, they would not permit this tragic waste to occur.
Unfortunately, they cannot walk in our shoes. Therefore, we
must constantly remind them of the critical need for donors. They
are on the front line. They are touching and feeling the pain of
their patient and his family. They can help to ease that pain by
suggesting that another life can go on through an irreplaceable gift
that they alone can give. . .
What greater gift can any of us give than one of life itself/ lhis
giving of life may be, at the time, the only light in a sea of dark
despair. One that can go on glowing for years to come, giving com-
fort and solace to those who have suffered an irreplaceable loss.
We must leave no stone unturned to seek out and retrieve all
possible organs. The ALF would like to recommend the following
actions:
First. Heighten awareness of the public about the need lor organ
donation through all possible media. Government and lay organiza-
tions can work together in this effort. A clearinghouse could also
help in this major role.
Second. Provide donor cards on the reverse side of all drivers li-
censes. Some states still need legislation to provide this service. We
could encourage this through our driver education programs.
Third. Inform physicians and nurses and allied health profession-
als about the critical need for organs. Of course, the American Hos-
pital Association, the American Medical Association, some of the
lay and professional organizations could get involved in this area.
Fourth. Establish criteria for recognizing brain death as death
through each state department of health.
Fifth. Establish a protocol for determining brain death in each
hospital through the Joint Commission of Accreditation of Hospi-
tals. This would be an appropriate medium for calling attention to
the need for donors and for emphasizing the positive benefits and
comfort families can derive from donating life-giving organs to vic-
tims of incurable diseases.
Sixth. Publicize in every health facility in the nation the hotline
numbers for donor procurement and donor information. Every
emergency room, intensive care unit and operating room should
have prominent posters identifying these numbers, to save time.
Time is critical, especially for the retrieval of livers. There is an
extreme urgency to expedite the process. The Department of
Health and Human Services could probably help in this effort.
Seventh. Finally, costs must be controlled. We must continue to
support the research to improve diagnosis, treatments and the
251
management of transplant patients while still supporting basic re-
search to find cures. In particular, we must work to find reasonable
answers to the cost of liver transplantation and support efforts to
fund this therapeutic procedure.
Thank you for calling us all together to help develop a plan for
saving lives. The American Liver Foundation will continue to work
to reduce the tremendous human suffering caused by liver diseases.
[The prepared statement of Thelma King Thiel follows:]
252
- AMERICAN LIVER FOUNDATION
TESTIMONY
OF
THELMA KING THIEL
Vice Chairman and Executive Director
American Liver Foundation
Before
The Subcommittee on Investigations and Oversight
Committee on Science and Technology
Chairman, Albert Gore, Jr.
April 14, 1983
253
-AMERICAN LIVER FOUNDATION
I am Thelma King Thiel, Executive Director and Vice Chairman of the American
Liver Foundation, Vice Chairman of the National Digestive Diseases Advisory
Board and an Advisor to the National Digestive Diseases Education and Infor-
mation Clearinghouse.
I am also the Founder of the Dean Thiel Foundation (DTF), the first health
agency to focus attention on liver diseases, the 4th leading cause of death
between ages 15-65. DTF is an affiliate of the American Liver Foundation.
My son Dean, in whose memory the Foundation was named, would have been 17 years
old today. He was diagnosed at two weeks of age as having cirrhosis from a
liver disease called biliary atresia. Each day of his four years on earth,
I prayed for research to find an answer to save his life. Research to me, at
that time, was an illusion ... an undefined entity that might be able to
create a miracle. I HOPED AND PRAYED . . . but my hope was very transparent.
Little was known and even less was shared with us as desperate parents.
Today there is true substance to the word HOPE. The replacement of diseases,
almost petrified organs, is possible. Today we can roll away the stone of
death and give new life to babies . . . children . . . mothers and fathers
with liver transplants.
As the mother of a child who suffered the agonies of Hell for four years, I
felt ANGRY . . . CHEATED . . . CRUSHED beyond belief to lose my precious
little boy. 17 years ago, a life saving liver transplant was not within our
grasp . . . Today the story is different. There is HOPE . . . MIRACULOUS HOPE.
254
AMERICAN LIVER FOUNDATION
But, with that hope come new frustrations . . . new problems.
Liver transplants can save lives IF
IF a donor in the required age frame can be found and the liver
retrieved quickly.
Another IF relates to money.
A new liver ... a renewed life is attainable, IF enough money
. is available to pay for this costly procedure. The American
Liver Foundation receives calls daily from desperate individuals
pleading for help. Where can they get the money to save their
child's life?
Frankly, ladies and gentlemen, I would have sold my soul if I
had bad a chance to save my son's life. I know how they feel.
Our time ran out . . . but their clock is still ticking.
In the 13 years since Dean died, I have dedicated my life to finding the answers
to liver diseases and am proud to be working with the American Liver Foundation
toward this end. We welcome this opportunity to share our concerns with you
and to help find solutions for some of these agonizing problems.
Over the years the low level of funding for liver research has resulted in
a severe lack of diagnostic tools to identify these insidious diseases until
irreparable damage has occurred. Effective treatments and cures are almost
non existent for many of the 100 liver diseases that attack children as well
as adults. Most Americans know little about the liver and the prevention
of liver diseases. Liver transplantation, a last resort procedure just a
few years ago, is the only hope for survival for thousands of Americans suffer-
255
AMERICAN LIVER FOUNDATION
ing with incurable liver diseases. The cost of a liver transplant represents
an investment in the restoration of a productive life for victims of liver
disease. The need for more liver transplant centers and trained transplant
surgeons is evident. The need for donors, a current problem, will increase
dramatically in the next few months as several more transplant units are
established .
How can we possibly meet the demand for more donors?
How can we stop the incredible waste of "life giving" organs, lost daily
through ignorance, indifference and perhaps fear?
If physicians and other health care providers could only feel, for just
one moment, the deep sense of anguish of a parent whose child's life is
slipping away . . . they would not permit this tragic waste to occur.
Unfortunately, they can not walk in our shoes. Therefore, we must constantly
remind them of the critical need for donors. They are on the front line.
They are touching and feeling the pain of their patient and his family.
They can help to ease that pain by suggesting that another's life can go
on through an irreplaceable gift that they alone can give. What greater
gift can any of us give than one of life itself. This giving of life may
be, at the time, the only light in a sea of dark despair . . . but one that
can go on glowing for years to come . . . giving comfort and solace to those
who have suffered an irreplaceable loss.
We must leave no stone unturned to seek out and retrieve all possible organs
256
AMERICAN LIVER FOUNDATION
every day. The list of recommended actions should be implemented as soon as
poss ible .
t. Heighten awareness of the public about the need for organ donation through
all possible media. Government and lay organizations can work together
in this effort.
2. Provide donor cards on the reverse side of all drivers licenses. Some
states still need legislation to provide this service.
3. Inform physicians, nurses and allied health professionals about the
critical need for organs.
4. Establish criteria for recognizing brain death as death through each
state department of health.
5. Establish a protocol for determination of brain death in each hospital
through a Joint Commission of Accreditation of Hospitals. This
would be an appropriate medium for calling attention to the need for
donors . . . and for emphasizing the positive benefits and comfort
families can derive from donating life giving organs to victims of in-
curable diseases.
6. Publicize in every health facility in the nation the Hotline numbers
for donor procurement and donor information. Every emergency room,
intensive care unit, and operating room should have prominent posters
identifying these numbers, to save time. Time is critical, especially
for retrieval of livers. There is extreme urgency to expedite the
process .
7. And finally . . . costs must be controlled. We must continue to support
research to improve diagnosis, treatments and management of transplant
257
AMERICAN LIVER FOUNDATION
patients while still supporting basic research to find cures. In particu-
lar, we must work to find reasonable answers to the cost of liver trans-
plantation.
Thank you for calling us all together to help develop a plan for saving lives.
American Liver Foundation, Cedar Grove, NJ 07009
258
AMERICAN LIVER FOUNDATION
YOUR LIVER - your most complex organ . . . yet the least understood
Liver Diseases are the fourth leading cause of death in Americans between the
ages of 15 and 65. Until 1976, however, no national organization existed to
focus attention on the human suffering and economic burden resulting from liver
diseases. The American Liver Foundation is acting as a catalyst to develop a
national sense of urgency that will increase the research needed to have a sig-
nificant impact on this sadly neglected health problem. Liver diseases are on
the increase and represent a major health hazard.
Liver diseases cause:
o 50,000 deaths annually
o $10 billion estimated economic cost
o 1 million hospital admissions annually
In addition:
o 32,000 deaths a year due to cirrhosis
o 8,000 deaths from cancer of the liver annually
o 20 million Americans have gallstones
o 500,000 gall bladder operations performed yearly
o 500,000 to one million new cases of hepatitis each year
Tragically, little has been done to address the increasing problem of liver dis-
eases. Why?
One problem is the lack of information about liver diseases among the general
public. They are unaware that liver diseases have many causes including:
o severe reaction to drugs (prescribed as well as over the counter)
o several types of viruses
o excessive use of alcohol
o prolonged exposure to environmental chemicals
o inherited and inborn abnormalities
o parasitic conditions
Patients often suffer from the stigma attached to liver diseases - a stigma based
on the misconception that liver diseases affect only alcohol and drug abusers.
Rather than endure this misunderstanding, patients conceal their illness, masking
the magnitude of the problem.
The low level of funding for research directed to liver and biliary tract dis-
eases has caused progress to be slow in fighting liver diseases.
More researchers and increased funding are needed to investigate liver problems.
Many opportunities for advancing knowledge in liver function and disease are lost
because the initial funds are insufficient and the potential for continued sup-
port is uncertain.
More liver specialists teaching in medical schools are needed to improve the
quality of care provided by newly trained physicians.
ALP, 998 Pompton Avenue, Cedar Grove, NJ 07009
259
AMERICAN LIVER FOUNDATION
American Liver Foundation Research Programs
An increased investment in liver research is essential to discovering cures and
treatments that will lessen the human suffering and economic burden that liver
diseases inflict on us all. The American Liver Foundation gives researchers the
opportunity to select and remain in liver research by funding the following
programs:
o Student Research Fellowship awards for medical and doctoral students to
stimulate their interest in liver research at a time when they are making
career choices,
o Postdoctoral Research Fellowship awards of $7500 which supplement N.I.H.
fellowship grants to provide a living wage for young researchers.
Education of Health Professionals '
The Foundation sponsors continuing medical education courses for physicians and
other health professionals on the important advances that have occurred in the
diagnosis, pathology and treatment of liver diseases - an important means of im-
proving patient care.
Pediatric Liver Council
The American Liver Foundation has developed the Pediatric Liver Council to ad-
dress particular needs in the area of children's liver diseases for research,
education, training of health professionals and family support. By publishing a
newsletter, SHARING CARES AND HOPES, the Pediatric Liver Council provides a means
for families to share their concerns and give support to one another.
Coordination of a National Effort Through Chapters
For those afflicted with liver disease, a sense of hope is essential: To meet
this need, the American Liver Foundation is organizing and coordinating mutual
help groups through its Chapters to provide emotional support for patients and
their families, make referrals to specialists when appropriate, and keep people
abreast of the latest research developments through special programs such as
"Meet the Researchers." These Chapters are assisting in educating the local com-
munity and increasing awareness of the need for more research as well as pro-
viding grass root support for all national programs.
How is the American Liver Foundation Funded?
As a non-profit, tax-exempt, national health agency, the American Liver Founda-
tion receives funds directly from the general public and through its Chapters in
the form of memberships, memorials, bequests and from special fund raising
events. In addition, the American Liver Foundation is the recipient of grants
from corporate and private foundations.
ALF, 998 Pompton Avenue, Cedar Grove, NJ 07009
260
SHARING cares and hopes SHARING cares and ho/>
AMERICAN LIVER FOUNDATION
PEDIATRIC LIVER COUNCIL
998 Pompton Avenue, Cedar Grove. N.J. 07009
Winter 1983
Sharing concerns with others who are experiencing similar problems builds
a special bond of friendship and understanding. It helps to provide the
strength and courage to face the uncertainty of the days ahead. Many
heavy burdens of care have been lightened by sharing joys and heartaches
with those who understand.
We are pleased to publish another issue of Sharing Cares and Hopes and
invite you to call or write us to add your name to our list of thoughtful
and concerned friends.
"A GRANDPA'S LOVE"
C/)
I
1
2J
u
o
z
s
<
My little Anneliese
How I have loved you from the start
Sharing with me your quaint little ways
You have stolen your Grandpa's heart
I have watched you touch both young and old
Cloaked in courage for all to behold
With innocence of child you have questioned not
As you have walked through the valley of doubt
Unselfish in love, undaunted in faith
A child's teaching of what life's all about
0' my precious little Annie
You symbolize what our Lord means life to be
When he spoke "Suffer the little children to
come unto me"
May I always be humble, even in moments of grief
and dispair
To know I was among those chosen in your
precious little life to share
And should the Lord send forth His angels
That we must bow to His command
I shall keep the child's faith you taught me
To know such things are wisely planned.
Our 7 year old daughter Anneliese has Biliary Atresia. She is jaundiced,
has an extended stomach, terrible itching and Cirrhosis which has caused
her to have 2 episodes of internal bleeding. We are pleased to share
this poem that was written for our daughter by her grandpa.
Eugene and Jerri Kedziorski
4248 A Street, S.E., #425
Auburn, WA 98002
206-939-9697
dctoq pue saieD OMIHVHS sadoq pue saaeD OMIMVHS sa<*°
261
November 27, 1978 will always be a special
day in my life. On that day I lost my four
year old dauahter, Seth, to a disease known
as Biliary Atresia. It hurt and it proba-
bly always will. A part of my heart be-
longs to her and even though I have two
other children, 7 and 2 years of age, no
one will ever take her place. We were
waiting for a liver transplant for Beth
when she died. I was furious because they
weren't able to find a liver for my daugh-
ter. I finally came to terms with these
feelinqs and decided that I had had Geth
for four and a half wonderful years. I
qave my dauqhter everything I had to give
and more. She touched all our lives in a
very special way. She enriched my life and
showed me, that no matter how badly losing
her hurt, life goes on. If there's anyone
else who's been through the same pain as I
have, please write or call. It would help
to know I 'm not alone.
Nancy Coppolino
7 Elm Street
So. Barre, MA 01074
617-355-274?
Rachel Joy had a Kasai operation for her
Biliary Atresia when she was 3 months old.
She's a very happy little girl now at 13
months of age. She has a problem with
fluid retention and Cirrhosis, although her
bilirubin count has been steadily drop-
ping. She is on a low sodium diet and
Portagen - loves puffed wheat; We know
that she's the Lord's, but are praying that
someday she will be able to receive a suc-
cessful liver transplant. We also have a 5
year old daughter, Julia, who is very lov-
ing and understanding. We are very thank-
ful for our Chapter and Christian friends
and family who are so helpful to us.
John and Carol Van Walbeek
2326 Springbrook Drive, N.E.
Cedar Rapids, IA 52401
1-319-393-5562
My son Scott is eight years old and in the
second grade. He was diagnosed with Alpha
1 Antitrypsin when he was a baby. I be-
lieve in the quality of life and strive to
help Scott to lead as normal a life as pos-
sible. Talking to other parents in similar
situations has been helpful. Only through
sharing thoughts, experiences and feelings
can we grow and learn to make life for us
and our children the best it can be. I
would love to share with other parents of
children with liver diseases.
Linda Bramble
3207 Highland Boulevard
Highland, MI 48031
313-887-2954
Pamela was born 5 1/2 years ago with Bili-
ary Atresia. After 3 Kasai Procedures and
several additional hospitalizations, Pamela
now functions as a normal kindergartener.
She plays the piano, goes to dancing school
and even attends summer camp. She is our
miracle and our joy and we cherish each day
that we share with her. We know that Pam
has Cirrhosis and a bilirubin which contin-
ues to climb. We live with the hope that
either a medical breakthrough or transplant
will allow her to live a long and normal
life. In 1981, I initiated efforts with my
N.J. Congressman, Senator and ALF to meet
with Surgeon General Koop and others to ex-
press our concerns about the role which the
Federal government might assume in liver
transplant research, support for the finan-
cially burdened families of patients and
the reclassification of transplantation
from "experimental" to "therapeutic." Sub-
sequent meetings were held and this June a
large Consensus Conference open to the pub-
lic, will take place in Washington to ex-
plore the entire issue of liver transplan-
tation. I have found that working toward a
goal both with the Foundation and my local
and Federal officials has helped channel my
energy and initiative in a positive dir-
ection. Much more needs to be done and I
welcome the opportunity to talk to others
with a similar perspective.
Gail and Jeff Rempell
41 E. Cheryl Road
Pine Brook, NJ 07058
201-575-3654
262
Little Emily Heiple jogs around the dining
room table, loves dressing up in her moth-
er's clothes, and attends Kindergarten.
She has a contagious smile which she loves
to flash when she's in trouble for writing
on the walls. She has one natural sister
and an adopted brother and sister. She's
the least disciplined of the 4 which can be
explained by her spending most of her first
2 years of life in Rochester, Minnesota un-
dergoing 4 operations for Biliary Atresia.
Emily is fast approaching her 6th birthday
in spite of elevated liver function tests.
She remains non-jaundiced but has Cirrhosis
and portal hypertension. Her energy level
far surpasses the rest of the family. She
usually wears everyone down while leaving a
trail of messy rooms behind as evidence.
It is difficult to think about the future
and what that means for Emily and our fam-
ily. We are interested in sharing with
other families how we have learned to live
one day at a time and enjoy it.
Rita and Joe Heiple
111 Graceline Boulevard
Waterloo, IA 50701
319-235-6986
Our Sara, age 3, appears to be as normal
and active a child as any in La Porte, In-
diana. Certainly her three surgeries and
11 hospitalizations are not apparent in her
snappy brown eyes and bouncy walk. Sara
has Biliary Atresia, but has responded to
surgical revision to drain bile. Sara is
one of a group of children treated at Riley
Hospital in Indianapolis, who are non-jaun-
diced and growing well after successful
Kasai Procedures. A biopsy late last sum-
mer indicated Sara's liver is functioning
well and incurring no new Cirrhosis. Sara
frequently talks about her painful experi-
ences. Even her dolls all have I.V. shots,
medicines, etc. We are so grateful that
the real tragedy of chronic liver disease
has not been her fate. The wasting away,
swollen belly, lack of lustre and energy
are not part of Sara's exuberant life.
Randy and Nancy McGriff
108 Lawrence Street
La Porte, IN 46350
219-362-7395
Our daughter, Michele, was diagnosed as
having Chronic Active Hepatitis at age 8.
She developed a secondary immune-complex
disease after beginning medication. She
experienced a number of side-effects from
Prednisone the first year of her illness.
Michele is now 12 and currently taj<es Pred-
nisone and Imuran. She has not developed
Cirrhosis and has almost full liver func-
tion. She is active in SDorts and only has
occasional problems from her illness. We
would be happy to communicate with other
Chronic Active Hepatitis patients.
Stan and Janice Lange
2024 North Street
San Angelo, TX 76901
915-949-0244
Our son, Alex, now six years old, was born
with a genetic enzyme deficiency of the
liver, Alpha 1 Antitrypsin Deficiency.
This deficiency was diagnosed at birth, be-
cause of prolonged jaundice and other prob-
lems. So far, our prayers have been an-
swered, and he is our miracle boy, since
his liver appears to be functioning ade-
quately. However, we continue to pray that
an effective long-term treatment can be
found. Our newest addition, another little,
boy, was born perfectly healthy. We beat
the odds!
Mrs. G. Bertram Wells
3112 Old Crow Court
Lexington, KY 40502
606-266-0379
Our daughter, Susie, was born June 16,
1978. She seemed to be a happy and healthy
baby but became jaundiced at one month.
After two biopsy's she was diagnosed as
having Byler's Disease, a hereditary dis-
ease of the liver. She is now 4 1/2, is
jaundiced and itches constantly. She is
behind most children her age and has a
hearing problem due to frequent ear infec-
tions. Our only hope for this very special
child God has given us would be a liver
transplant one day. We would like to write
to others to share our special concerns.
Owen and Clara Mi 1 ler
R #3 16020 Nash Road
Middlefield, OH 44062
263
Our beautiful 26 month old daughter Summer
was diaqnosed at 2 months as having Biliary
Atresia. Her Kasai was done at that time
with a biliostomy. She had a fair amount
of drainaqe and it was reconnected when she
was 21 months old. Her condition is stable
but her Cirrhosis is considerably advanced.
When she was 2 she was examined in Pitts-
burgh for a transplant but nothing will be
done unless she gets worse. This uncer-
tainty is murderous! We are starting a
Chapter of ALF in Houston. We would love
to talk to anyone concerning liver disease.
Debbie and Tommy Martin
1506 Sue Barnett
Houston, TX 77018
713-686-1770
Lauren was diagnosed at 13 months with
hereditary Tyrosinemia. The prognosis was
grim. We spent a long time trying to deal
with that tragic sentence. Our lives and
values changed dramatically. Our family,
friends, and even some doctors had never
heard of Tyrosinemia. We wanted to talk
with other families with Tyrosinemia but
none of our medical contacts were able to
help. A year later, through a friend, I
heard of the American Liver Foundation. I
called Thelma Thiel, Executive Director of
the Foundation, who knew of another family
with a similar problem and we were able to
talk to them. At 2 1/2 cancer was diag-
nosed in Lauren's liver, and she was given
3 to 6 months to live. The idea for a
liver transplant came from "Sharing Cares
and Hopes." I called Thelma for her input,
and she gave me Dr. Thomas Starzl's phone
number. Five days later we were in Pitts-
burgh for transplant evaluation. After
much public appeal and the enormous gener-
osity of many people, Lauren had transplant
surgery in November '81. She looks great,
has enormous energy, and loves nursery
school. The American Liver Foundation
played a vital role in saving Lauren's life.
Beatrice and Joseph Toohey
12 McKinley Drive
Kinnelon, NJ 07405
201-492-0920
Our daughter, Alesha, died Christmas Day
1982. In April, at 2 months, she had been
diagnosed as having Biliary Atresia. The
Kasai Procedure was done although no major
bile ducts were found. Two days after she
left the hospital bile began to flow.
Alesha was stable until October when a
serious infection set in. A call to the
American Liver Foundation brought us infor-
mation and much needed support from
Veronica Otterberg of ALF's Omaha, Nebraska
Chapter. Her condition worsened in Novem-
ber and we realized that a transplant was
only life saving option and found that the
cost was very high and at this time she was
too small to have the surgery. We decided
to set up a trust account and began to
raise funds to defray the cost of a liver
transplant. Having spent a week in the
hospital before Christmas, Alesha 's condi-
tion had stabilized enough for us to take
her home Christmas eve. She was alert and
we had a wonderful loving time with the
whole family. That night our little dar-
ling died peacefully in my arms. We are
grateful for the thoughtfulness and concern
we received from our dear friend Veronica
and the ALF. We thank them for their work
in education, research and providing mutual
support for parents and families. We would
be willing to share the concerns of others.
Glenda and Vince Mahaney
Route 4
Denison, IA 51442
712-263-6686
Micki is planning to go to College in the
fall. At 17, her Chronic Active Hepatitis
with Cirrhosis is in remission and she is
involved in many extra curricular activi-
ties at school and has a part time job.
Micki recently did a term paper on liver
transplants and is extremely interested in
new advances in research. We have made
some marvelous friends and are coping much
better with Micki ' s Hepatitis. We'd like
to help others the way we've been helped
through sharing our concerns with others.
Marie Mendl
117 Arbor Vitae R4
Metamora, 1L 61548
309-383-4665
264
AFFILIATES
Dean Thiel Foundation
Thelma King Thiel
30 Sunrise Terrace
Cedar Grove, NJ 07009
201-857-2626
Pediatric Liver Research Foundation
Phi 1 ip Aristone
Route 206
Tabernacle Road
Indian Mills, NJ 08088
609-268-2074
CHARTERED CHAPTERS
Michael and Laura Pagel
810 Wildwood Court
Streamwood, IL 60103
312-837-9102
Randy and Nancy McGriff
108 Lawrence Street
La Porte, IN 46350
219-362-7395
Elizabeth A. Mullendore
680 Woodale Terrace, Apt. 2
Greenwood, IN 46142
317-881-4768
Dick Vallin
700 Jamestown Road
Auburn Heights, MI
313-333-0356
48057
Tom and Michele Sherrill-Mix
427 Saginaw Street
Alpena, MI 49707
517-356-9265
Carmela Colucci
154 Rumsey Road
Buffalo, NY 14209
716-886-0084
Sheila Ivrin
87 Ashland Drive
Kings Park, LI, NY 11754
516-265-3878
Anthony Shee
123 Red Bud Drive
Beaver Falls, PA 15010
412-847-3504
Richard Norgaard, M.D.
Barnett Tower
3600 Gaston Avenue
Dallas, TX 75235
214-824-3212
Peggy Cathy
4808 N.E. 41st Street
Seattle, WA 98105
206-525-0180
CHAPTERS-IN-FORMATION
Dorothy Simms
1064 Celestial Way
Yuba City, CA 95991
916-673-4584
Ken Donahue
245 S. Westgate Avenue
Los Angeles, CA 90049
213-476-2304
Brenna Dean
5501 Trent Court, #110
Alexandria, VA 22311
703-379-3959
Joyce Ferrante
9120 Fontainbleau Blvd.
Miami, FL 33172
305-223-1959
#401
265
CHAPTERS-IN
-FORMATION
Joyce Ferrante
Kate Collins
9120 Fontainbleaj Boulevard, #401
2250 Connell Terrace
Miami, FL 33172
Baldwinsville, NY 13027
305-223-1959
315-635-5141
Rita Heiple
Mattie Lee Mil ler
111 Graceline Boulevard
818 Colonial Drive
Waterloo, IA 50701
Burlington, NC 27215
319-235-6986
919-584-6958
Bonnie Cubbage
Tom Davey
3938 Brooklyn Avenue
643 Genenbi 1 1 Drive
Baltimore, MD 21225
Cincinnati, OH 45238
301-355-2402
513-451-3475
Peter McCue
Bonnie Schmidt
160 Commonwealth Avenue, #218
27413 Detroit Road
Boston, MA 02116
Apt. G-32
617-536-7151
Westlake, OH 44145
216-835-0112
Walne Casanova
P.O. Box 552
Dorothy Mandelbaum
Picayune, MS 39466
2290 N. 53rd Street
601-798-4518
Philadelphia, PA 19131
215-877-2856
Veronica Otterberg
6915 Evans Street
Debbie Martin
Omaha, NE 68104
1506 Sue Barnett
402-571-5417
Houston, TX 77018
713-686-1770
Cynthia Gales
17 South Portland Avenue
Mary Ann Armijo
Brooklyn, NY 11217
2507 Summitview
212-522-2762
Yakima, WA 98902
509-575-6521
American Liver Foundation
30 Sunriie Terrace, Cedar Grove, N.| 07009
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266
Mr. Gore. Thank you, Mrs. Thiel.
We will now have questions for the panel.
We have two beneficiaries of transplants on this panel. There are
so many others who are awaiting transplants. The subcommittee
has been literally flooded with letters from parents from around
the country. Some of them have been provided by you, Mr. Fiske,
and we have been flooded with pictures of beautiful children who
are waiting for transplants. Clearly we need a national strategy to
solve this problem.
In addition to research and development, it seems to me there
are three issues, in ascending order of importance. The first is a
better organization for organ procurement; second, the removal of
the funding obstacles that so many families have to hurdle; third,
and most important of all, the raising of the awareness in this
country of how important organ donation is.
We could solve most of this problem if families across this coun-
try had a conversation over the dinner table or at the breakfast
table and said to each other, as a family we think that organ dona-
tion is a good idea, that we hope no tragedy ever occurs in our
family, but if one dies, at least it could lead to hope and joy for
some person who might not live without an organ transplant.
Mr. Fiske, I want to ask you a question about that issue first.
What would you say to a family that was having a conversation
around their dinner table and somebody in the family spoke up
and said, "Well, I just don't think that organ donation is a good
idea. I am a little nervous about it. I don't like to think about it. I
don't like to think about dying. I don't like to think about an organ
being removed after death." What would you tell that person?
Mr. Fiske. I think, Mr. Chairman, you have probably hit the nail
on the head by saying that it is families themselves, talking like
that informally, where the change really does take place.
I think my first response to anybody like that, the fact that it is
even talked about is encouraging. The fact that somebody says no, I
don't think it is a good idea, they are raising the issue within the
family. I think that is probably very encouraging. If that takes
places, then it is a very optimistic sign.
I think what I would suggest to any family where that does come
up is to keep talking about it. To cram that idea down somebody's
throat, to force them into it is not the way to go.
I think probably the clearest example of that in our case was the
Bellon family, having two children, at 5:30 at night, happening to
have the TV on and making that decision subconsciously at that
point. The following Tuesday they had done it. I think it has to be
a free kind of choice and it has to be an ultimate gift kind of
choice.
I would suggest to family members, if there is that kind of resist-
ance, what are the obstacles to that. What is the reason for not
doing that, and respecting that kind of decision because I think
that really has to remain there, that each individual does have
that choice to say I don't think it is a good idea.
I think it is healthy to keep bringing that up. I guess that is
what I would recommend, is to continue talking about it.
It is easier to talk about it around particular cases. You are talk-
ing about two very difficult situations. On the one hand, the donor
267
person who is going to be declared brain dead, and the other
person who will die by not having a transplant. They are both very
difficult concepts to handle.
It becomes a bit more understandable around individual cases.
Michele is probably a good example right here because she has had
the benefit of that kind of giving. Jamie is a good example.
The whole issue of transplantation across the board is a hard one
to understand. If you take a look at Jamie, with Jamie right now,
there are two other children that I have seen. I don't think I have
ever met them, but I would say that both of those children have
some form of end-stage liver disease that probably will need a
transplant at some point.
I think when people see these two children side by side, to say
Jamie was where these children are, that is a good thing to do.
Even though it may be difficult to talk about dying, it may be diffi-
cult about talking about those issues, Jamie directly benefited from
the Bellon family in Utah taking the time to give that gift of life.
If it is made very concrete, and if that is done over a period of
time and people discuss it, then it doesn't become so conceptual. It
becomes something that a family can say take a look at Jamie,
here she is, as the pictures demonstrate the before and the after.
There is a marked difference.
I guess that is what I would suggest.
Mr. Gore. I think that is a very effective way to do it. I hesitate
to ask this of any of the families who have come here, but do you
care to say something? If you care to speak to the subcommittee — I
know this is unusual and I will ask my colleagues' indulgence — Dr.
Ogden, if you could let her take your seat briefly, we could take
Mr. Fiske's advice and just paint the issue in as stark terms as pos-
sible.
Your name, ma'am, is?
Mrs. Goode. Virginia Goode. I am from Morningside, Md. This is
Nicky.
Mr. Gore. You live in the area?
Mrs. Goode. Yes.
Mr. Gore. And your child's name?
Mrs. Goode. Nicholas Goode. He is 22 months old. He has biliary
atresia. He has been waiting for 5Vz months for a donor.
Mr. Gore. He has the same condition that Jamie Fiske, right
behind him, had?
Mrs. Goode. As does the little girl over here, who is 13 months
old. She is Candy Thomas.
Mr. Gore. How old is your child?
Mrs. Thomas. One year old.
Mr. Gore. And the name of the child?
Mrs. Thomas. Candice.
Mr. Gore. Candice Thomas is the child's name.
In other words, the point you were trying to get across, Mr.
Fiske, is much more clearly illustrated by the difference between
these two children.
Mr. Fiske. I think it is a gift of life situation, where you are talk-
ing about the opportunity of giving life to somebody else through
some kind of generous thinking about it. With our situation, the
268
Bellon family, in the midst of the death of their son, Jess, thought
about life for Jamie. .
So you have two contrasting kinds of ideas: the one issue of
dying, but also in the process of that, extending and giving life to
somebody who desperately needs that particular organ. Jamie is a
good example of receiving a gift of life in the midst of a death situ-
ation with the Bellon family.
Mr. Gore. Mrs. Goode, you are still waiting for an organ to be
donated for your child, is that correct?
Mrs. Goode. Yes, sir. .
Mr. Gore. Mrs. Thomas, you are still waiting for an organ to be
donated for your child, too?
Mrs. Thomas. Yes.
Mr. Gore. Biliary atresia, also?
Mrs. Thomas. Yes.
Mr. Gore. And you are from the local area, also?
Mrs. Thomas. Accokeek, Md.
Mr. Gore. Thank you very much. I appreciate that very much.
Mr. Fiske, I have one other question and then I want to turn to
my colleagues.
On the question of funding, I think it is very important to note
that if someone in your situation, in your home town, went back to
the same Blue Cross-Blue Shield company and asked for funding of
a liver transplant, they would be likely to be turned down. Isn t
that correct?
Mr. Fiske. To answer very clearly what they said to me in writ-
ing, "Due to the extenuating circumstances in this particular case,
we have made an exception."
Mr. Gore. In other words, because of what they regarded as a
mistake and then because of the enormous amount of national pub-
licity, they made an exception in your case. But there are other
cases where families need a liver to be transplanted to save the life
of their child, where the same company will refuse to pay for it.
Mr. Fiske. The other thing I think that should be mentioned is
that liver transplants are not the way to go to treat liver disease. If
I can put that in context, Jamie had an extremely difficult situa-
tion with biliary atresia. Other procedures were tried ahead of
time. She had an 8-hour operation in February, and a 4-hour oper-
ation in July. The last treatment of choice was a liver transplant.
If we didn't have to go through that, we would not have. We had
no other choices at that particular point in time.
What was happening, too, is the sicker that Jamie got the higher
the medical costs got. If you take a look at her hospital bills from
July 6 through the date of transplant, they increase markedly be-
cause she was declining at a rapid rate. After that, they reached a
peak with the transplant and then declined.
On December 16 she left, and the only hospital bill that we have
had facing us from Blue Cross-Blue Shield is that 2- to 3-day
checkup in Minnesota, which was to see how she was doing. It is
somewhat cost effective to have given her the liver transplant.
Mr. Gore. It is a good point. We certainly hope that we can
change the financing policies of the Federal Government and the
private insurance companies to save lives and, as you point out, to
save money, too. It is ironic that it would do both at the same time.
269
Congressman Skeen?
Mr. Skeen. Thank you, Mr. Chairman.
I would like to comment on how traumatic I am sure it is for
those of us who have never been touched by this kind of a problem
to say well, this evening we are going to read the Bible and right
after that we are going to have a discussion about being an organ
donor.
That probably ought to be a good procedure in a family, if they
only knew how important this discussion might be. I think it was
pointed out in the testimony that the media has played an ex-
tremely important part.
We are fond, in the great halls of this body, of castigating the
media time after time for some of the things that they don't do, but
very seldom do we ever give them credit for some of the good
things that they do. I know that it creates some problems, too, inso-
far as ethics about whether the media influences, gives someone an
advantage and so on. However, they have done an outstanding job
in this area, as has been pointed out in both cases today, I know in
Michele's.
It is very difficult for people to overcome a natural repugnance
at the idea of talking about donating organs. It is something that
we need as a society to learn to do, is to get over the idea that
there is something wrong or bad about talking about leaving parts
of ourselves.
There is only one way besides procreation on this earth that you
can extend life, and now we have the technology to do that. It is
another form. I think you said it very well, Mr. Fiske, that this is a
new way to give life. The technology involved in the medical world,
the pharmaceutical world, and so forth is a great gift and one we
should take advantage of.
I want to ask Michele a question because I know that in our own
family circle — Michele, you did an outstanding job. You weren't
nervous at all during your testimony; I told you it would be OK.
I know that Michele had a question in her mind. This young lady
has had to take the brunt of making those decisions, where the
family could help only to a certain degree. Mr. Fiske had a differ-
ent type of a problem. Mr. and Mrs. Fiske had to make the deci-
sions for their child. But one of the difficult decisions that Michele
had to make was whether or not to go family donor or to go ahead
and consent to a cadaver donor.
Michele, I would like to know, how did you finally change your
mind? I know for some time you had decided that you would only
accept an organ from some member of the family. I know it was a
tough decision for you, but it changed the whole outlook on your
problem. How did you finally make that decision? Was it tough?
Ms. Jones. Well, when I started I was going to go living-related. I
had five family members to choose from. Through the tissue typing
they had decided my sister was the best choice. She was a perfect
four match. But she said no because she had two small children
that she was worried about, who may develop kidney problems
sometime that she might want to donate to.
The other four members were a two match. My one brother had
said he would like me to go cadaver first. He was a law student,
270
and he was starting his last year of school and wanted to get into
practice.
It had gotten down to the three other members, my mom, my
father, and my other brother. They sat there and bounced it back
and forth between the three of them on who had lived the best so
far, like I have lived the longest, I have lived a full, happy life. If
something should happen to me on the table, then we have nothing
to complain about. My brother would say no, I should, we need to
have the parents around.
They went back and forth with this so much and they would not
let me decide. It was something that I couldn't decide for them. Fi-
nally, I think I got so fed up with them not making a decision, not
deciding, that I decided cadaver, that was the way I was going to
I also released the pressure from them. I was releasing pressure
from other family members outside of the immediate family, like
my aunts, because they had worried about my father donating be-
cause there had been kidney problems on both sides of the family
on my dad's side. My mom had had kidney stones, which wasn't
really related to what I had. Finally I said that's it, I am going ca-
daver. I did get the transplant.
Mr. Skeen. I think it is an important element in this discussion
because here again is a situation created where everyone wants to
help, but within a family it can cause such an aura of tension, so
you have to learn to deal with this kind of a problem as well.
I think it is far easier to discuss among the family the possibility
before an acute problem occurs. I think every family ought to do
this and should they be asked, be ready to make the decision that
at your death you want to donate organs. Otherwise the alterna-
tives that this young lady had were extremely difficult and almost
caused an alienation within the family.
That is just another one of the things that is happening. I think
it is extremely important.
I would like her to elaborate on the financing. Michele, how are
you financing your operation?
Ms. Jones. When I first started on dialysis, we tried to go
through Blue Cross-Blue Shield. It took much, much help from you
and from several others to get Blue Cross-Blue Shield going and
start making payments. As soon as we got medicare stepping in
and taking over 80 percent, Blue Cross-Blue Shield has kind of
backed out of the picture. That is one thing I would like to say
about it.
Mr. Gore. Will my colleague yield?
Mr. Skeen. Certainly.
Mr. Gore. One of the problems that the liver patients face is
they don't have the kind of funding mechanism that Congress es-
tablished for kidney transplants. Medicare will now pay for kidney
transplants, but liver patients have to mount either a nationwide
publicity campaign or in some other way raise the funds on their
own before they can even get on the list.
Mr. Fiske said that Jamie couldn't even get on the list to be con-
sidered for a transplant until he could work out the financial con-
siderations with Blue Cross-Blue Shield. It really shouldn't be that
way.
271
Mr. Fiske. She was placed on the list on the 29th of September,
the same day that Blue Cross-Blue Shield authorized funding for
that.
Mr. Gore. So just as soon as you got the authorization, she was
put on the list?
Mr. Fiske. She had gone out there for a 2-week evaluation. They
were ready to make that decision on that Thursday. That Wednes-
day, Blue Cross-Blue Shield called and said we are not going to
honor the letters we have given you. She was placed on it on the
29th, the same day that they authorized payment.
Mr. Skeen. Mr. Chairman, I think that is an interesting point
and one that we should resolve through these hearings; that is, the
fact that medicaid and medicare, are willing to pay $250,000— they
have that much exposure — on a person that is going to die.
On the other hand, it is more cost effective to enter into the pro-
grams of transplants at this stage, and with the stage of success
that we have it would be far less expensive.
I hope that we can maybe make some kind of determination
along that line as we go into the discussion on this because it
would be a very interesting economic discussion. It is probably
much more costly to let someone die. You lose, particularly in the
case of these young patients, the productivity of a lifetime from the
individual as opposed to being willing to pay for the death or
absorb the cost of dying, which is extremely high in itself.
I would like to see if we can make some of these comparisons and
then come up with some resolve from this group to encourage the
private insurance suppliers or the private carriers, as they are
called, and the Federal Government to change its mind in some
regard to accept and to accommodate itself to the new techniques
and new technology involved in transplants. We have made the
breach now with kidneys. Why not livers and some of the rest of
the transplant procedures that have proven high success rates?
Thank you very much, Mr. Chairman.
Mr. Gore. Thank you.
Congressman Reid.
Mr. Reid. Thank you, Mr. Chairman.
I would like to acknowledge the great education that I have re-
ceived the last couple of days and commend you and the staff for
putting this hearing together. I think the whole Congress is fortu-
nate to have you involved in setting some of the things that we are
doing.
The reason we are having this hearing is basically because Chair-
man Gore, as the chairman of this subcommittee, looked into dif-
ferent areas that needed attention in the science and technology
field. I again, Mr. Chairman, publicly commend you for this hear-
ing and certainly congratulate the staff on putting together a well-
rounded panel.
I have been touched a number of times today by the statements
that have been made by various people. I don t know of anything
that we could do that is more important than dealing with saving
lives, and that is what, in effect, we are doing today.
Mr. Fiske, let me ask you a question. This probably in the overall
scheme of things is not important, but it is a question of curiosity
in my own mind.
272
With adoptions, we do everything we can to keep the identity of
the natural parents away from the child. You have had such a
close relationship with this Utah family, the Bellon family, do you
feel that it is desirable that you know who the donor is?
Mr. Fiske. I think in our circumstance we could probably only
deal with the family in Utah. The general feeling we had picked up
from the staff at the university hospital in Minnesota was that the
donor remain anonymous.
We respected that kind of decision because it is a very, very
tragic time for that family, to face that kind of issue. We knew
that we would have liked to have had contact with them, but we
respected the wishes of the experienced people at Minnesota sug-
gesting that that remain anonymous.
When we got a call from the social worker at Primary Children's
Hospital in Salt Lake City, she said that the family would appreci-
ate hearing from us either by telephone or by writing.
We were delighted to be able to do that because we knew, as dif-
ficult as it was for us to talk with them, we needed to be able to
say to them thank you, not even having the words to say thank
you, but just to have that kind of contact to let them know that
they did something for Jamie that nobody else in the country was
able to do at that time; that is, to think beyond their own tragedy
and to think of giving Jamie hope, the hope of getting better.
We are fortunate in our situation that the family is encouraged
by Jamie doing well. The tragedy of their own situation, they are
handling that now. It is, I am sure, very difficult and very painful
for them to do, where their son was IIV2 months old.
We couldn't say that that should be the case across the board,
that everybody have contact with the donor family. We do know
that in our own situation we have had contact with them.
We realize how difficult in some ways it was for them, but the
thing that keeps coming through from the family when we talk
with them is how is Jamie doing, how much does she weigh, is she
sitting up, is she talking, thank you for the pictures that you sent
out. There is that sense of extension out of their situation. We
don't get from them a sense of bitterness. We do get from them a
sense of hope that Jamie will continue to do well.
Right after the operation — there are high points and low points
with Jamie's getting better. We could share those moments with
that family because they wanted her, as well as we wanted Jamie,
to get better.
How that would work for other situations and other families we
really don't know, but our experience with the Bellon family in
Utah, we are excited that they are excited about her doing well.
As I mentioned before, they have become part of Jamie's ex-
tended family. They, in the midst of a very tragic situation, offered
hope. I think a family doing that, in the midst of a tragic situation,
gives hope and gives life to that family out there that does need
that particular organ. That is what we are talking about, is a gift
of hope and a gift of life.
Mr. Reid. Mr. Chairman, I have a question I would like to ask
Dr. Ogden.
Doctor, first of all, is there a need for donor centers, a central
place, a regional central location where the donated organs would
273
go? It would seem to me that many of the small institutions where
people die in the sense like we heard yesterday, where their brains
are gone but their bodies, they want them to keep working. Maybe
we need a central location for donors of organs.
Second, the second question, would more money mean more
transplants, generally, not just kidneys but things in general?
Dr. Ogden. Let me respond to the first question first.
We don't need a donor organ center because you are speaking es-
sentially of an organ bank. The organs we are talking about can't
be banked. They have to be maintained in a living state or a recov-
erable-to-life state.
The time between removal of the organ from a donor and place-
ment of the organ in the recipient varies according to which organ
we are talking about. The longest is for kidneys. We don't like to
see it go much beyond 24 hours, up to perhaps 36 hours.
Actually, the organ is obtained by a group, which can be local, or
a group can go to the hospital to obtain a kidney or other organ.
This is done all the time. Then the organ is transported to where
the waiting recipient is.
The second question was whether more money would mean more
organs. I think in the broad sense you can say yes, but the hangup
is not specifically money. I think it is very hard to get to the real
core of this.
I recognize, first of all, that almost all usable organs come from
healthy, relatively young — middle-aged or less, usually — people
who were doing their thing moments before or hours before and
who have a sudden tragedy. In this country at this time, that usu-
ally means motor vehicle accidents, cars, motorcycles. Not always,
but usually.
I am particularly gratified to see that the two transplants repre-
sented here at this table, in both instances the family of the donor
came forward. I think we need to recognize that it is very difficult
to have the health care team caring for the potential donor recog-
nize the potential of that situation and come forth and suggest do-
nation.
In fact, the health care team caring for the donor, their job is to
represent the donor's interest. By the time they recognize that
death is imminent, donation may be impossible. The potential
donor may be in such medical condition by the time the care team
caring for that patient — the physician, ICU nurses, et cetera — are
willing to say this person is in fact going to die, that in fact they
are not a donor anymore, they are not suitable as a donor any-
more.
So, the problem of identifying somebody who is going to go
around and say this is a potential donor puts that person, whoever
that is — a transplant coordinator, an ICU nurse, another physi-
cian— in conflict with the best interests of the care team caring for
the person who might have been or might be a potential donor.
All I am saying is that it makes it very difficult to find that fine
point in time between which a person is in fact dead, or about to be
brain dead, and still is not so dead that the organs are not useless.
That is part of the problem, resolving that problem. When the
family suggests the potential of donation and recognizes the futility
of the situation, then it becomes so much easier because they have,
274
in fact, recognized it. It is possible now to think that way. It is pos-
sible for the care team to think that way.
Mr. Reid. Thank you, doctor.
Thank you, Mr. Chairman.
Mr. Gore. Congresswoman Schneider?
Mrs. Schneider. Thank you.
Mr. Fiske, I think that it is interesting to note that you went
through a great deal of struggle in order to get your message
across, that you were looking for a liver for Jamie. It was through
the media that you were able to locate a donor.
Michele, it was pretty much the same situation. It was through
the media, somebody hearing on the news that you were seeking
the need of an organ transplant.
Mr. Fiske, I would just like you to make some comment as to the
role you see in the future to try to improve the connection between
the supply and the demand of organs, what role you see the media
playing in the future.
Mr. Fiske. In some of the stuff that we went through, it was
myself and Marilyn sitting down on a daily basis, making the kind
of decisions like where to go and how to go about it. One of the
things we didn't have was a clear game plan of what to do. It was
the kind of day-by-day decision, once Jamie got put on the list, to
figure out where to go.
Anything we did, we always bounced off the medical community
in Minnesota, running it by them. One of the things we didn't want
was that the media make medical decisions. We didn't want the
media to come in and say — we wanted the doctors to make that
kind of decision. We also wanted the doctors to know that we were
taking steps. So both of us actively traded off the privacy we had
with the possibility of Jamie getting better.
Our intention in going to the American Academy of Pediatrics
was to go back to the medical community, to doctors, predominant-
ly pediatricians, so that they they could raise — one of the things
that I mentioned when I addressed them was that the trauma we
are talking about for your situation may not have already hap-
pened.
What we were hoping was those pediatricians would go back,
raise that issue in that relationship that they have with their fami-
lies and the patients that they treat. It is kind of a sacred relation-
ship that they have, where you entrust your children to the pedia-
trician's care. So, we went through that.
The media's involvement in that was very clear, in getting that
message from New York City to Alpine, Utah. There was a family
watching that, but it was in front of a medical forum that that was
done.
As a result of our original intentions with that particular medi-
cal group, I have had calls from doctors. A doctor in Missouri
called me. He had been at the convention. I got a call several
weeks ago, and he said he had heard about that stuff. He was
treating a patient named Kelly Johnson, and he wanted to know if
I could give him the names of the doctors in Minnesota so he could
call them. It was interesting because the thing we wanted for
Jamie, this doctor had picked up on, was responding to, and getting
involved in this particular case of biliary atresia.
275
What the role of the media is, in our situation the media were
always fair to us. There wasn't a massive invasion of privacy. We
turned to the media willingly and knew that what we considered as
privacy, to hold on to that may cost us any help for Jamie.
Mrs. Schneider. I understand that, but it seems to me that your
experience clearly denotes that anyone who is in a similar situa-
tion of looking for an organ ought to have a media game plan. I
think that certainly that was one element that helped.
Yesterday in our testimony we heard how there are many nurses
that are aware of possible deaths among some patients, and they
are becoming more involved now in providing that information
link, which seems to be the missing link in all of these discussions.
Mr. Fiske. To say the media has to be the salvation of everybody
that needs a transplant I don't think is accurate. In our particular
situation that was a choice that we made. That doesn't have to be
the choice for every single family. It may not be.
Mrs. Schneider. But you succeeded, and I think it is an example
where others probably will try to follow in your footsteps.
Mr. Fiske. What may have been right for Jamie may not be the
way to go for every family. I think what has to be in place is some-
thing a lot more secure than media coverage of the situation; in
other words, there has to be a system in place to do that so that
the likes of myself and Marilyn don't have to go to the likes of Sen-
ator Kennedy, Senator Tsongas, Congressman Moakley, the Speak-
er of the House, asking them to assist us, and then going back to
the media or going to the American Academy of Pediatrics.
I think what happens is that that may happen once or twice, but
after a while that may lose some effect that it may have. I think
what needs to be in place is something is a lot more long lasting
than the immediate need of one child, something that families who
are not facing this will have a sense of hope that we really didn't
have.
Mrs. Schneider. I think it is quite clear that your comments now
are indicative of how disorganized the structure is in order to solve
the problem. I think that one of the efforts to solve the problem is
the donor alert program, the 800 number.
Your neighbor to the south, in Rhode Island, my constituent, was
here testifying yesterday. Are you familiar with the program that
he has set up?
Mr. Fiske. I have talked with Ray Coleman. As a matter of fact,
we were talking about getting together prior to this week, but our
schedules were so conflicting.
I think Ray's background had been law enforcement and was
very keenly aware that the role that police officers have in terms
of identifying situations that are in the middle of the night, they
are looking for the name of the person that may be involved in an
auto accident, and their ability to say to the EMT or to the doctor,
gee, this particular person here has a donor identification tag on
his license, to think about that as they are bringing the person in.
I think again that is that whole other area of support personnel
with the medical community. You have people like Ray who are
very much involved in it from his perspective because of that group
of people, called law enforcement, who see tragedy more regularly
276
than most of us. His effort to bring that out I think again is one
person who sees a need and is trying to do something for that.
It is encouraging, especially with the Pinheiro family, Ray called
me the day before we came down here to mention that Justine had
received notification from Pittsburgh. I think Ray is thoroughly
committed to that, much as we are now as a family, because
nobody should be in the same situation that we were.
If there is anything that we can do — and I am sure Ray feels the
same way from his perspective — to alleviate some of that burden,
as far as organ donor awareness, we are thoroughly in support of
that.
Mrs. Schneider. I am delighted that you mention it because that
is the perfect lead-in to my next comment.
As you know, this committee is going to be making recommenda-
tions after our 3 days of hearings. Granted, some of them will be
very substantial in reference to the cost concerns of financing these
operations. We will be discussing with the Federal officials and the
medicare system what solutions are possible.
But there is obviously a need for continued citizen participation,
and it seems to me that if we move along the lines that have al-
ready been initiated, for example, having the communications link
with all of the doctors and nurses across the country, that is ex-
tremely vital.
I would also be inclined to make the recommendation, as Mrs.
Thiel has mentioned earlier that the many groups across the coun-
try get together and work as a team to provide a support system.
It is quite clear that not only is the money necessary along with
the donor location, but the family also needs some kind of support
system. I think that is the kind of public service that can be pro-
vided by many of these nonprofit organizations and individuals,
such as yourself.
So, I am hopeful that your organizations and the individuals who
are concerned will closely read our recommendations because I, for
one, having come from the public sector and being a citizen activ-
ist, am supportive of all efforts such as your own, but obviously
there is a need for coordination and coalition building.
I am hopeful that you will pick up that ball and keep running
with it because that is a very vital part of the whole solution to
this.
Mr. Fiske. Tuesday morning I met with the National Kidney
Foundation of Massachusetts, the Massachusetts General Hospital
Bone Bank and the New England Organ Bank. Their feeling was
that they don't have money in their budgets to do public aware-
ness.
Their thrust in their organizations is transplantation, identifica-
tion of donor organs, preservation of those organs, but they don't
have the ability to go out and educate the general public.
Their feeling very clearly, at least in the New England area, is
any kind of support that they could back into, they would be will-
ing to go hand in hand with that; if they could turn that public
awareness over to a particular group to be able to do that, because
again they don't have the ability to do that.
Mrs. Schneider. We should begin to focus on the New England
region, I for one will volunteer, and I am sure I can work with Con-
277
gressman Moakley and put together a couple of ideas and see if we
can coordinate our efforts.
Mr. Fiske. Again, anything that you would need from myself and
Marilyn, we would thoroughly support that.
Mrs. Schneider. Thank you very much. I appreciate your testi-
mony and your presence here today.
Thank you, Mr. Chairman.
Mr. Gore. Congressman Durbin?
Mr. Durbin. Mr. Fiske, Mrs. Fiske, when you were waiting for
that letter from Blue Cross, did you have a contingency plan in
mind, what you were going to do if they said no?
Mr. Fiske. The overriding thought in our mind — and this is,
again, speaking for both of us — was we did not want Jamie to die. I
think what happened was Jamie had a very healthy period from 2
months to about 5 months and then the disease she had advanced
pretty quickly. Anything we could have done we would have done.
Again, funding very clearly is an obstacle and it caused us a lot
of aggravation, a lot of worry, and it could have meant her not get-
ting that operation.
I wish that was the only obstacle. The biggest obstacle that we
faced that we had no control over was her declining health. The
second major one was identification of a donor. After that, I would
put the issue of funding.
That is not to downplay the role of funding, but making her
better and identifying $100,000, if it was that simple, then you
would do that. If we thought getting $100,000 would make her
better and we would go back to Massachusetts and say goodbye
Minnesota, it would have been great.
Funding did present an obstacle. I think what we would probably
have had to do — we went, again, through Governor King at that
point in Massachusetts and requested medicaid approval for Jamie.
Since she had been declared disabled, having been in the hospital
longer than 70 days, we had petitioned the Department of Public
Welfare that she be approved for medicaid funding. Through Gov-
ernor King's office, the commissioner, Tom Spirto, on October 29,
authorized funding for her for that operation.
Mr. Durbin. Would that have required some kind of means test,
as far as you were concerned, that you would have surrendered a
certain amount of your assets, your family assets?
Mr. Fiske. No. That is one of the questions that had come up. In
Jamie's case, since she had been in the hospital longer than 70
days she, under social security, was declared disabled.
Apart from any assets that we would have as a family, being de-
clared SSI eligible in her case made her eligible for medicaid in
Massachusetts. Being eligible for medicaid allowed us to go ahead
and petition the commissioner of public welfare to give prior ap-
proval to that type of surgery.
The difficulty that that presents with Blue Cross-Blue Shield is
that there was no guarantee, even though they put in writing that
they would follow through. Also, with medicaid, it is a case-by-case
decision.
The problem we had was the time factor. Her surgeon, the day of
the surgery, came down the corridor to us, Dr. Najarian, and Dr.
Ascher. He looked at us and then he looked down at his hands and
278
said, right after the operation, "Looking at her liver, I would have
given her 10 days to live." So, we knew time was running out. He
very clearly told us on November 5 that time was 10 days ahead
for her dying.
I think we would have had to raise that kind of money in a door-
to-door campaign. The citizens of the Commonwealth of Massachu-
setts, as well as the town of Bridgewater, we never really asked for
money. People sent us money in envelopes.
The Governor declared Jamie Fiske Day November 12, for the
purposes of offsetting some of those supporting medical costs. Citi-
zens in Minnesota, through Senator Rudy Bosch witz, set up a fund
out there to offset some of those living costs, some of the flying
back and forth between Boston and Minnesota.
People were extremely generous, their wanting to help us as a
family, not only in Massachusetts and Minnesota, but we got let-
ters from as far away as Texas, California, Maine, of people want-
ing to help by sending money.
It would have involved us petitioning people for that kind of
money to take care of it. Again, the obstacle that that presents is
the day that Jamie was put on the transplant list, September 29,
was the same day that Blue Cross-Blue Shield authorized the pay-
ment for that operation.
Mr. Durbin. So you had to have the money before you made the
list?
Mr. Fiske. In true justice to the University of Minnesota, they
never held Jamie's health care in ransom. They told us very clear-
ly to secure the funding before we came out, but they never said,
we are not going to treat her and send you back home unless that
money is in place.
But it is coincidental, though, that they did ask that we get that
in writing from Blue Cross-Blue Shield. When she was put on the
transplant list was the same day that Blue Cross-Blue Shield did
come through.
Mr. Durbin. Mrs. Thiel, you testified earlier, and I guess you put
it together in a couple words very succinctly, about this tin cup
syndrome. We have heard the testimony from Mr. Fiske about
what he and his wife faced if they couldn't get the Government ap-
proval and if the private insurance company had said no.
The thing that crosses my mind is how many people have the
awareness in their own mind of what can be done? How many
people are intelligent, have enough drive in a situation with per-
sonal adversity that they are going to start searching for the media
and looking around? How many are poor and wouldn't know where
to start?
I am just wondering if you have any thoughts about that whole
tin cup approach and what we ought to do about it.
Mrs. Thiel. I think there are very few people that are as sophis-
ticated as the Fiske family and have the contacts and would know
what to do. I know that years ago, when my son was diagnosed, I
would not have known where to begin.
When these families call, they are really at their rope's end.
Some of them have been told that they have to have upfront
money of $300,000 before they will even consider evaluating their
279
child. That is a desperate situation. I don't know where I would go
for $300,000.
As I say, the only thing that we can do is give them guidance, to
talk to your insurance company. You really have to do battle with
your insurance company. Don't take no for an answer. Talk to your
legislators. See what coverage your carry from medicaid-medicare
in your area.
Then, of course, try to get some of the local organizations, the
fire department, the junior league, and so forth, some of the civic
organizations, to help you to raise that money. This has happened
in many areas.
Again, I think as more awareness is created through radio and
television programs, that people are doing this. I think that the
media has been very, very responsive to the needs of a lot of these
families.
Mr. Durbin. There have been suggestions, and we have heard
them from time to time, about some efforts in the Government, on
the Federal and State levels, toward catastrophic insurance, to help
families in this particular predicament when the medical bills have
gone beyond a certain point and gone beyond the means of most
American families.
What do you think of that? Do you have any problems with that
in your own mind of embarking on that kind of program, even
though we are living in pretty difficult times economically?
Mrs. Thiel. We are always looking at the dollars. Of course, liver
transplants have come into view much more recently. I don't be-
lieve that a kidney transplant is as costly in general as a liver
transplantation. But when you consider the value of a life com-
pared to the cost of that liver transplant, I think that there is no
question in my mind at all.
Mr. Durbin. I knew you would answer that way.
Dr. Ogden, yesterday I mentioned to the panel that when I
worked in the Illinois State Senate we adopted the Uniform Ana-
tomical Gift Act. We tried to make some progress with our driver's
licenses, to put the consent on the back of a license.
Do you feel that that, aside from increasing public awareness,
which I think it has done, has really created a good link between
donors and recipients when it comes to organ transfer in your own
mind?
Dr. Ogden. No, I don't think it has. I think it has increased
awareness. In that regard, we are beginning increasingly to see
families who, in the appropriate circumstances, request a consider-
ation of donation. The initiative is increasingly coming from the
next of kin of the injured person. So, I think it is helping in that
indirect sense.
It is rarely that the driver's license is used as the legal document
through which transplantation is achieved. It happens, but it is
rare.
My particular suggestions were that the recorded wish of an indi-
vidual on their driver's license be, in fact, noted on admission of
anybody to a hospital of significant size, in the hope that, in fact,
one that would lead all along the trail the health care team and
the individual and family, because if they request the driver's li-
cense to record your donor status, immediately you have focused
280
attention on that without saying we want you to make a decision.
Now you are sick, we want you to make a decision about whether
you want to be a donor I don't think that is appropriate.
I do think that if you have already made that decision, it focuses
on it slightly but doesn't make a big deal of it, to say let's see your
driver's license and record what is on there. It also would increase
the sense of it throughout the hospital. Wherever the patient went,
this would basically be recorded. I think in that way we could
begin to make use of the driver's license.
By the way, there is no uniformity from State to State about the
way in which this is handled. In at least one State you must make
a declaration of yes or no. Well, faced with having to say right now
whether you want to be a donor or not, most people put no.
In some States it is entirely optional. In some States you are
asked whether you want to make a declaration. In other States you
aren't asked, but if you ask them, if you would know enough to ask
at the driver's license bureau, they would say oh, yes, and then
they will pull out an affidavit and record it on there.
Mr. Durbin. I think that is most people's experience.
Dr. Ogden. So, there could be room for gaining a greater degree
of uniformity about how this is handled, assuming there could be
that kind of agreement on a national basis.
Mr. Durbin. Can I ask you two other questions somewhat related
to that in your experience?
Have there been problems related to the definition of brain
death, in terms of all States not adopting the same standard, that
have resulted in delay or the loss of a donated organ?
Dr. Ogden. Yes, there has even been active resistance in some
States by various facets of the medical community and lack of the
ability to come to agreement.
The wording of the uniform brain death law, which has been
adopted by 28 States, I believe, seems satisfactory although actual-
ly that wording hasn't been adopted by 28 States. Twenty-eight
States have a brain death law, not always of the same wording.
I think again this is an area we need to encourage. In some
States, declaring a person brain dead is not a legal way to declare
death.
There is an opportunity here— perhaps this hasn't been com-
mented on. A brain death law serves more function than simply in
organ donation. It establishes criteria by which brain death can be
pronounced whether or not organ donation is even a consideration.
If the individual, for instance, is 70 years old, that person is prob-
ably not a potential organ donor for any of the organs we have
been talking about today. Yet, in the absence of a way to recognize
and pronounce brain death, there is a likelihood that the care will
be extended beyond that point which might otherwise be necessary,
at additional expense.
What I am saying is that a brain death law can be cost effective
in terms of not providing unnecessary medical care.
Mr. Durbin. Thank you very much.
Thank you, Mr. Chairman.
Mr. Gore. The subcommittee just received a communication from
LeBonheur Hospital in Memphis that Brandon Hall's condition is
good. The prognosis is good, but the condition is critical. They are
281
saying that his chances are 50-50. There was a 12-hour operation.
Doctors announce that he suffered cardiac arrest twice during the
operation and, as a result, they are cautiously optimistic. I am sure
we will be hearing a good deal more from LeBonheur.
If I was asked to summarize the basic purpose of these hearings,
Mr. and Mrs. Fiske, it would be this. Parents should not have to go
through what you had to go through in order to save the life of
Jamie. They should not have to experience what Mrs. Hall had to
go through in order to try to save Brandon's life.
There are many Jamie Fiskes and Brandon Halls, and there are
going to be many more to come. We need to save them by design-
ing and establishing a national strategy that will help parents in
the situation that you found yourselves in, to remove the obstacles
of financing, to remove the obstacles in the form of increasing
awareness among American citizens about how important organ
donation is, and to better organize the organ procurement system
nationwide, so we can save these children's lives in the future.
I want to thank all of our witnesses on this first panel for being
with us. You have helped us in our effort. We are precisely halfway
through our 3 days of hearings. I would like to thank you again for
helping us out.
Mr. Fiske. Thank you, Mr. Gore.
Mr. Gore. Our next panel is made up of Prof. Alexander Morgan
Capron, Executive Director of the President's Commission for the
study of ethical problems in medicine and biomedical and behavior-
al research; Dr. Robert Veatch, professor of medical ethics and
senior research scholar at the Kennedy Institute of Ethics at
Georgetown; and Dr. James Childress, professor of religious studies
and professor of medical education in the Department of Religious
Studies at the University of Virginia in Charlottesville.
I would like to welcome all three of our witnesses here today.
Professor Capron, as Executive Director of the Commission on
Bioethics — that is what I call it, rather than its long name — we
have had an opportunity to talk with you on several occasions.
As you know, we have the highest regard for the work you have
done, and we are honored to have you leading off this panel on the
bioethical considerations involved in a national strategy for organ
transplantation and organ procurement.
Without objection, your entire prepared statement will be includ-
ed in the record. Please proceed with your presentation.
STATEMENTS OF ALEXANDER MORGAN CAPRON, EXECUTIVE DI-
RECTOR, PRESIDENT'S COMMISSION FOR THE STUDY OF ETHI-
CAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAV-
IORAL RESEARCH; DR. JAMES CHILDRESS, PROFESSOR OF RE-
LIGIOUS STUDIES AND PROFESSOR OF MEDICAL EDUCATION,
DEPARTMENT OF RELIGIOUS STUDIES, UNIVERSITY OF VIR-
GINIA; AND DR. ROBERT M. VEATCH, PROFESSOR OF MEDICAL
ETHICS, SENIOR RESEARCH SCHOLAR, KENNEDY INSTITUTE
OF ETHICS, GEORGETOWN UNIVERSITY
Mr. Capron. I appreciate the opportunity to testify, in civilian
dress, now that the Commission has concluded. From an ethical
and legal vantage point, it seems to me that the central question is
282
what should society's response be to the need of tens of thousands
of Americans for complex and expensive forms of treatment for
grave illnesses, particularly when the treatment draws on limited
resources and, though of demonstrated value, is still partially ex-
perimental.
Because of the lateness of the hour, I want to abbreviate very
much what I have to say and offer an opportunity for any ques-
tions. I divided my observations into those which deal with the
scarcity of organs and the scarcity of funds.
SCARCITY OF ORGANS
Looking first at the question of cadaver organs, there are three
issues: First, the lingering uncertainty about the determination of
death, which we just heard about in the exchange with Mr. Durbin;
second, the lack of adequate donations; and third, the inadequate
coordination of the organ donor process. Let me make a few obser-
vations on these.
You are familiar with the work of the President's Commission on
the Determination of Death, and I have summarized that in an at-
tachment to my statement. The Commission, along with the Na-
tional Conference of Commissioners on Uniform State Laws, the
American Bar Association, and the American Medical Association,
recommends the adoption of the Uniform Determination of Death
Act. That law is now effective in 14 jurisdictions. We are waiting
still for congressional action on that, which was contemplated in
the 97th Congress, and might happen in the 98th, to cover Federal
jurisdictions and as a spur to State adoption.
The Commission strongly recommended that the adoption of the
statute be kept separate from the Uniform Anatomical Gift Act,
which is law in all 50 States and the District of Columbia, because
the two subjects, although linked, are not coterminous.
The second question, which deals with the inadequacy of the
supply of organs, relates to the fact that despite the comments that
were just made by the representative of the Kidney Foundation, I
do not believe that we know what part of the population has taken
steps to make an inter vivos gift, an intention to give a gift, that is,
under the Uniform Anatomical Gift Act.
Several alternatives for increasing donation above the level
which now exists would involve changes in the law. The first would
be going to a system of payment either made to a person during
the lifetime to be binding at the time of death, or made to rela-
tives. Given our poor history with the sale of organs, such as blood,
already I believe most commentators in this field view a movement
toward a marketplace in organs as an unfortunate step. Certainly
most physicians object very strongly to this.
Mr. Gore. You see no evidence of that, do you?
Mr. Capron. One sees evidence of it from time to time — ads in
newspapers offering organs, kidneys, corneas, things like this — but
I think it is a very unusual thing still because most physicians
don't want to participate.
Of course, a seller and buyer could engage in an arrangement in-
dependent of the knowledge of the physicians involved. It is not un-
usual when there has been a true donation for the donor to have
283
medical expenses paid. There is a fine line between paying medical
expenses and paying time off from work, if you are talking about a
live donor, and so forth, or expenses of the funeral, if you are talk-
ing about a deceased donor. So, there is a shading between a
market system and a donation system.
The major objection, I think, is that the present system, which
involves a gift relationship, has certain important values for soci-
ety irrespective of the practical question of whether one would, as
in the blood area, end up with organs that were less suitable than
from a system of unpaid donations. For one thing, if you turn
something into a market, the incentive for other people to be altru-
istic to make a donation seems to be decreased.
A second alternative at the opposite extreme would be an option
of statutes allowing the State to take organs on a compulsory basis
without consent as a routine matter, on the grounds that organs
are valuable resources that a deceased person should not be al-
lowed to destroy. In my reading of constitutional law, it would
appear to require a high-level justification for such a taking, even
from cadaver donor bodies.
Mr. Gore. No one has recommended that one, have they?
Mr. Capron. Oh, yes, it has been recommended. In 1968 there
was a recommendation to that effect, a law journal article detailing
that. That is all in my materials that I provided to the committee.
Mr. Gore. Thank you.
Mr. Capron. The third is replacing what we now have, which is
sometimes referred to as an opting-in or contracting-in system,
with an opting or contracting out system; that is to say, to begin
with the presumption that everyone would want to donate and
then permit people during their life to indicate that they do not
want to be included.
One suggestion to that effect was made by Prof. Jesse Dukemin-
ier of UCLA in 1968. The problem with his suggestion was that he
would also allow the relatives to object after death. The major im-
pediment to the use of organs at the moment is the uncertainty
that surrounds the point of donation: Has the person made a
choice? What are the relatives' wishes? Can the relatives be con-
tacted in time? Does one feel comfortable intruding upon their
grief by discussing this subject with them?
If we were to have an opting-out system, that included relatives,
as Dukeminier proposed, I don't think we would gain anything. If
you had an opting-out system which only relied on the individual's
own choice, it would seem to me to be very probable that we would
gain in terms of the number of organs because public opinion polls
done on this subject for the last 15 years have shown that the
public by overwhelming numbers, 70 to 80 percent favor donations
and would wish to make a donation. Yet, we know that only some
far lower proportion of people actually fill out the cards during
their lifetime — though I don't know anyone who has good statistics
on this, despite statements that are made.
All of these alternatives deserve some exploration, but I for the
moment would think that we need to give greater emphasis, as the
previous panel told you, to increasing donations under our present
system.
284
I think we have an excellent legal framework in the Uniform
Anatomical Gift Act [UAGA] and the Uniform Determination of
Death Act for donations. What we need is greater public informa-
tion and education, to make people aware of this as something
which they ought to do during their lifetime to avoid the grieving
situation for their family.
I would, therefore, urge you to lend your support to efforts by
private, State and Federal groups to publicize the UAGA so as to
preserve the great ethical as well as social values in voluntary do-
nation. If that is judged inadequate to obtain needed organs for
transplantation, I suggest at most an amendment of the UAGA to
make donation automatic unless a person opts out during his or
her lifetime.
The third issue about donation from cadaver organs is the need
for sharing of organs. Scarcity at the moment breeds a proprietary
attitude toward organs among those who, in the term of art, ' 'har-
vest" them. Even with kidneys, the attitude has been that the hos-
pital at which the procedure is done will typically say we will keep
one for one of "our" patients and put the other one into the
system.
The problem with this is that for a good match— and the better
the match, even with present immunosuppressive agents, the
better the likelihood of a good survival— you need to increase the
pool of recipients and donors being compared with each other on a
tissue-typing basis.
Furthermore, it contradicts notions of fairness as well as good
sense when organ availability depends upon the ability of particu-
lar recipients or their family members to generate publicity for
their plight. You can imagine that the news media are really not
that interested after the first Jamie Fiske story and the second,
third, fourth, and fifth liver transplant. The interest dies down. It
seems to me that the spectacle, whatever cathartic function it may
serve for the public once a donor is found, is contrary to our usual
norms of the proper way in which medical care should be deliv-
ered.
Depending upon logistical considerations, I believe that a region-
al or national system of organ transfers would be advisable, with
support by local coordinators to facilitate the actual donations. I
believe you should endorse surveillance and coordination by the
CDC in this field.
I won't elaborate in my comments now on my prepared remarks
on living donors. It is a more minor issue. The case that came up
recently in Iowa, it seems to me, was an unfortunate one and I
hope that that decision by the judge is reversed on appeal, so that
people understand that their participation in this system will be
judged by the usual norms of confidentiality and they will not be
subject to the kind of pressure that the judge apparently decided
was suitable on that woman as a bone marrow donor.
SCARCITY OF FUNDS
The scarcity of funds raises a problem which we see now
throughout medical care. The ethical issues posed for public and
private decisionmakers are those that arise whenever scarcity is in-
285
volved, which are the questions of the societal obligation and of
fairness.
My two basic conclusions in this area are, first, that the issue is
not how to avoid making difficult choices among people in need by
throwing more money at the problem, but rather how to make
such choices in a justifiable manner; and second, I conclude that
we must develop means for determining how new medical develop-
ments relate to society's obligation to insure equitable access to an
adequate level of care.
The availability of reimbursement through medicare's special en-
titlement for end-stage renal disease hasn't ended our ethical prob-
lems there. Physicians, nurses, hospital administrators still have to
agonize over cases, asking whether a particular treatment should
be used with a particular patient. Moreover, it is quite obvious by
now that we cannot say "yes" to funding every treatment. We
must instead make sure that we don't say "no" unfairly.
In addressing the issue of society's ethical obligation toward
health care, the President's Commission determined that the stand-
ard of equity requires that everyone have access to an adequate
level of care without the imposition of excessive burdens.
Defining adequacy is clearly a difficult task. To eliminate repeti-
tion on this point, I have set forth the Commission's discussion in
one of the appendices to my statement.
Of greatest relevance here are two points: First, while judgments
about whether a particular treatment are not solely matters for
professional judgment, expertise of the sort that the National
Center for Health Care Technology in HHS was beginning to devel-
op before it was abolished, regarding the reimbursement under
Federal health care financing programs, could certainly be very
valuable.
Second, since the greatest test of fairness will probably be compa-
rability, decisionmakers, particularly those in the public sector
whose decisions are likely to be generalized, must keep in mind the
tendency of limited acts of generosity to have very broad ramifica-
tions.
I urge that you explore with HHS its ability to assess the rela-
tionship of particular treatments, not just organ transplantation, to
the adequate level of health care that should be guaranteed by so-
ciety to its members in a manner that is fair and consistent.
I regret, Mr. Chairman, I think as you and your staff knew, I
have an obligation to teach a class. I have 125 students waiting.
With the indulgence of my copanelists, I would welcome your ques-
tions now, Mr. Chairman.
[The statement of Mr. Capron follows:]
23-029 0-83-19
286
Statement of Alexander Morgan Capron, Professor of Law, Ethics and Public
Policy. Georgetown University Law Center
ETHICAL AND LEGAL ISSUES IN ORGAN REPLACEMENT
Good morning, Mr. Chairman and members of the Subcommitte,
and thank you for inviting me to address some of the legal and
ethical issues in organ transplantation. I applaud your decision
to take up this important and timely topic and hope that my
remarks will be helpful in your explorations.
As the chairman has already mentioned, I was until just
recently the director of a presidential commission that studied a
wide range of bioethical problems. Although I will draw on the
work of that commission in portions of what I have to say today,
I am not speaking on behalf of the Commissioners. Indeed, while
a number of the 11 reports of the President's Commission touch on
today's topic, the Commission did not study the subject directly.
From an ethical and legal vantagepoint, the central question
as I see it is: what should society's response be to the need of
tens of thousands of Americans for complex and expensive forms of
treatment for grave diseases (usually chronic in nature but also
imminently life-threatening) , particularly when the treatment
draws on limited resources and, though of demonstrated value, is
still partially experimental? That is a complex question which,
I believe, captures most of the issues I'd like to address.
I. SCARCITY: ORGANS
You have already heard, yesterday and earlier this morning,
about the numbers of patients with kidney, heart, liver, or lung
conditions who might benefit from organ transplantation or
mechanical substitution. I would like first to discuss the
issues raised by their need for organs for transplantation. In
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287
the case of most organs, the only source is a cadaver; in the
case of kidneys, as for bone marrow and blood products, there are
two sources for such organs: living donors as well as cadavers.
These two sources raise somewhat different issues.
A. Cadavers
Under the Uniform Anatomical Gift Act (UAGA)--the most
successful act, in term of uniform adoption, of any proposed by
the NCCUSL — a simple and effective method already exists in every
state for the donation of cadaver organs. If organs were
obtained for transplantation from all people who die each year
under circumstances that would make them suitable organ donors
(and if these organs were then distributed in an efficient
fashion) , there would be more than sufficient supply for present
estimates of need and medical capability. Unfortunately, this is
not now the case for several reasons: (1) lingering uncertainty
about the legal "definition" of death; (2) lack of adequate
donations, by people during their own life or by their relatives
after the patients' death; and (3) inadequate coordination,
locally, regionally and nationally.
1. "Definition" of Death
The first statutorily mandated subject addressed by the
President's Commission was the "definition" of death. This
subject is, as you know, relevant to organ transplantation,
because to maximize their potential benefit to recipients, organs
should removed as quickly after the donor has died as possible,
preferably while they continue to be nourished by oxygenated
288
blood circulating as a result of artificial support of the
deceased's heart and lungs.
For the sake of brevity, I have appended to these remarks
the summary of our conclusions from the opening pages of the July
1981 report Defining Death (Attachment A) . The two points most
relevant, here are: first, that the Commission, along with three
other leading groups, recommended adoption of the Uniform
Determination of Death Act (UDDA) , which is now law in 14
jurisdictions, including the District of Columbia, although
consideration of an enactment for areas under federal
jurisdiction, which was expected in the 97th Congress, never
occurred; and second, that the Commission urged that the UDDA be
kept separate from the UAGA. Although it was the advent of heart
transplantation that brought the issue of "defining" death to. .the
public's attention— and, indeed, that prompted the medical
profession's attention to the conclusions of the 1968 Harvard Ad.
Hoc Committee (205 J. A.M. A. 337) —the need to update the legally
recognized standards for determining that someone has died does
not rest primarily on any need to facilitate organ transplan-
tation but on the confusion created for the old heart-lung
standard by the use of modern forms of treatment that can
simulate the traditional "vital signs" in patients who are
actually dead. (See Attachment B for excerpts from the
Commission's report on this point.)
Most American jurisdictions now have some form of modern
"definition" of death. Greater public and professional certainty
on the issue would be provided if the UDDA were adopted in all
289
jurisdictions, and if those people — principally physicians and
public officials concerned with health issues — who educate the
public on such matters were to be careful with their terms, so as
not to perpetuate any lingering sense of "two kinds" of death
(i.e. , one for organ donors, the other for the "truly dead") or
of a "dead body" being maintained by "life support" equipment,
and so forth. The reliability of modern medical criteria for
determining that death has occurred is manifested by the
guidelines of the Commision's medical consultants (Attachment C) ,
which the Journal of the American Medical Association hailed as a
"landmark" event.
I urge you to provide leadership on this issue, both
through Congressional action on the UDDA and, even more
important, through encouragement to the states to enact --
the UDDA.
2. Inadequate Donations
Public polls have consistently found that an
overwhelming majority of Americans favor organ donation, yet only
a proportion of the population — the exact figure is, to the best
of my knowledge, unknown — has availed itself of simple procedures
of the UAGA. A larger number of donations occur because the UAGA
also permits specified relatives to donate the organs of a dead
person who did not make a decision to so so during his or her
lifetime; these choices are frequently complicated by having to
be made in the context of the relatives' grief (and often shock)
over the death of person, which has typically occurred suddenly
and often violently.
290
In a book written a decade ago, Catastrophic Diseases; Who
Decides What?, Dr. Jay Katz of Yale and I considered a number of
alternatives to the UAGA, including a payment procedure, "opting-
out" in place of "opting-in," or compulsory removal of suitable
organs. From an ethical and social vantagepoint , all of these
alternatives have the disadvantage of turning what is now part of
a "gift relationship" into a "taking" or "sale" — but such
considerations might be overridden if voluntary donations do not
produce socially satisfactory results. (Again, for the sake of
brevity, excerpts from our book are appended as Attachement D.)
Since that time, some states have attempted to increase
participation by linking the "donor card" in several ways with
driver licensure; however, it does not appear that adequate
studies of various methods — much less vigorous educational
efforts — have been generally undertaken. If we are to move
beyond the UAGA, I continue to believe that a pure form of
"opting-^out" — rather than the proposal made in 1968 by Professors
^Dukeminier and Sanders (279 New England J. Med. 413) , under which
next-of-kin could also object to removal of the organ — would be
the next best alternative.
I urge you to lend your support to efforts bv private,
state and federal groups to publicize the UAGA. so as
to preserve the great ethical as well as social values
in voluntary donation; if that is judged inadeouate to
obtain needed organs for transplantation. I suggest the
amendment of the UAGA to make "donation" automatic
unless a person "opts out" during his or her lifetime.
291
3 . Inadequate Coordination
The scarcity of organs makes them very dear; the burdens
imposed in obtaining organs, including the burden of going to a
grieving family to ask permission, increase the tendency to treat
them as a resource of the local facility. Yet any limitations on
the widest possible sharing of organs among transplant groups is
medically unfortunate. Despite improved methods of fighting
rejection, a better "tissue match" increases the likelihood of
success, and the wider the pool of donors and recipients, the
greater the likelihood of a good "match." (See Attachment E.)
Certainly, it contradicts notions of fairness as well as good
sense when organ availability depends upon the ability of
particular recipients or their family members to generate
publicity for their plight; moreover, this spectacle — while
serving a cathartic function for the public if someone comes
forward with an organ to relieve a patient's desperate plight — is
contrary to our usual proper norms of medical privacy and human
dignity.
Depending on logistical considerations, I believe that
a regional or national system of organ transfers would
be advisable, with support for local coordinators to
facilitate donations. You should encourage
surveillance and coordination by the CDC in this field.
B. Live Donors
The use of living donors raises a number of serious issues
primarily centered around voluntary, informed consent (see second
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292
part of Attachment D infra) . The major issue needing continued
attention is that of the participation of minors as donors
(primarily of bone marrow) for their relatives.
Another concern — the social expectation of privacy and
voluntariness in organ donation — was drawn into question by a
recent case in Iowa, in which a man with leukemia was attempting
to learn from the state university hospital the identity of a
woman whose tissue type was known by the hospital to be a good
match for an experimental bone marrow graft to treat his
leukemia. The Institutional Review Board had shown, in my view,
appropriate sensitivity to the ethical questions in the way that
it had permitted the physician-investigator to inquire in a
nonspecific way whether the woman (who had been "typed" as part
of an attempted treatment of her own child's leukemia) would be
willing to consider donating bone marrow to patient-subjects in
experimental treatments. It is regrettable that the trial judge,
insisted that she be recontacted with the specifics of the
instant patient's needs; the case is now on appeal.
II. SCARITY: FUNDS
The need for organs for transplantation makes this field
somewhat unusual — but the expense of transplantation, like that
of mechanical replacement for failed organs, raises questions
that assert themselves with increasing urgency in the health
arena. The ethical issues posed for public and private
decisionmakers are those that arise whenever scarce funds are at
issue, namely issues of obligation and of fairness. My two basic
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293
conclusions in this area are (1) that the issue is not how to
avoid making difficult choices among people in need "but rather
how to make such choices in a justifiable manner, and (2) that we
must develop better means of determining how new medical
developments relate to society's obligation to ensure equitable
access to health care.
&*- Making Choices
A decade ago the federal government did an extraordinary
thing: in the face of the suffering and death of a majority of
the patients with end-stage renal disease (numbering in the
thousands) who could not obtain treatment (principally,
hemodialysis) that had already been shown effective in sustaining
life and restoring "normal" functioning, Congress amended the
Medicare law to guarantee federal funding of therapy for this..
single disease entity. (The Commission reviewed this history
briefly, as an example of the theme of "limited resources" in its
final report; see Attachment F.)
What have we learned from this experience? First, that the
predictions of the cost of such programs are very unreliable.
While we ought not to overgeneralize from that experience — since
the particular legislation was enacted without a detailed
examination that might have produced somewhat more accurate
forecasts of costs — we ought also not forget it. Demand tends to
rise well above projections, particularly when medical and
institutional prestige, and personal and corporate profits, are
playing a role in determining "demand."
294
Second, and more important, we have learned that money is
only briefly effective as a "cure" to relieve our collective
discomfort over having to make moral choices, particularly
choices that appear to be God-like: "who will live and who will
die?" Although the funds are now available to treat chronic
renal failure in any patient, physicians, nurses and health
administrators must draw a line somewhere — not as the British
health system does, based upon age, but upon a combination of
factors. For example, in reporting last month on Deciding to
Forego Life-Sustaining Treatment, the President's Commission
stated that because the benefit to the patient would be so small,
it would be "very hard to justify dialysis for a permanently
unconscious patient who develops kidney failure" (p. 190) .
Although the line of "no benefit" is a clear one,
difficulties of choice persist when particular patients in need
are indentif ied; it then becomes very difficult to deny any life-
supporting treatment of possible benefit. But we must — and
perhaps at the level of statistical risk and so forth, we will be
able to — draw seme line, unless we are prepared to say patients
are guaranteed access to any and all care they want, "need," or
might possible profit from receiving.
B. Equitable Access
In addressing this issue of society's ethical obligation
toward the health care of its members, the Commission determined
that the standard of equity requires that everyone have access to
an adequate level of care without the imposition of excessive
burdens. Defining "adequacy" is clearly a difficult task, and to
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295
eliminate repetition, I have set forth the Commission's discus-
sion of this point, in Securing Access to Health Care, as
Attachment G to this statement. Of greatest relevance here are
two points: first, while judgments about whether a particular
treatment are not solely matters for professional judgment,
expertise of the sort that the National Center for Health Care
Technology (in HHS) was beginning to develop (regarding
reimbursement under federal health care financing programs)
certainly could be valuable; and second, since the greatest test
of fairness will probably be "comparability," decisionmakers
(particularly those who operate publicly, whose judgments are
thus most likely to be treated as being generally applicable)
must keep in mind the tendency of limited acts of generosity to
have very broad ramifications.
I urge that vou explore the ability of HHS to assess
the relationship of particular treatments — not just
organ transplantation — to the adequate level of health
care that should be guaranteed by society to its
x members in a manner that is fair and consistent.
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296
Capron 4/14/R3
ATTACHMENT A
Excerpts from
Defining
Death
A Report on the
Medical, Legal and
Ethical Issues in the
Determination of Death
July 1981
President's Commission for the Study of
Ethical Problems in Medicine and
Biomedical and Behavioral Research
297
Summary of
Conclusions and
Recommended Statute
The enabling legislation for the President's Commis-
sion directs it to study "the ethical and legal implications
of the matter of defining death, including the advisability of
developing a uniform definition of death."1 In performing
its mandate, the Commission has reached conclusions on a
series of questions which are the subject of this Report. In
summary, the central conclusions are:
l.That recent developments in medical treatment ne-
cessitate a restatement of the standards traditionally recog-
nized for determining that death has occurred.
2. That such a restatement ought preferably to be a mat-
ter of statutory law.
3. That such a statute ought to remain a matter for state
law, with federal action at this time being limited to areas
under current federal jurisdiction.
4. That the statutory law ought to be uniform among the
several states.
5. That the "definition" contained in the statute ought
to address general physiological standards rather than med-
ical criteria and tests, which will change with advances in
biomedical knowledge and refinements in technique.
6. That death is a unitary phenomenon which can be ac-
curately demonstrated either on the traditional grounds of
irreversible cessation of heart and lung functions or on the
basis of irreversible loss of all functions of the entire brain.
7. That any statutory "definition" should be kept sepa-
rate and distinct from provisions governing the donation of
cadaver organs and from any legal rules on decisions to ter-
minate life-sustaining treatment.
M2U.S.C. §1802 (1978).
298
Defining Death
To embody these conclusions in statutory form the
Commission worked with the three organizations which
had proposed model legislation on the subject, the Ameri-
can Bar Association, the American Medical Association,
and the National Conference of Commissioners on Uniform
State Laws. These groups have now endorsed the following
statute, in place of their previous proposals:
Uniform Determination of Death Act
An individual who has sustained either (1) irrevers-
ible cessation of circulatory and respiratory functions,
or (2) irreversible cessation of all functions of the en-
tire brain, including the brain stem, is dead. A deter-
mination of death must be made in accordance with
accepted medical standards.
The Commission recommends the adoption of this statute
in all jurisdictions in the United States.
299
ATTACHMENT B
Excerpts from
Defining
Death
A Report on the
Medical, Legal and
Ethical Issues in the
Determination of Death
July 1981
President's Commission for the Study of
Ethical Problems in Medicine and
Biomedical and Behavioral Research
300
60 Defining Death: Chapter 5
Uniformity Among People and Situations: Besides
moving slowly, the law ought to move evenhandedly. The
statute ought not to reinforce the misimpression that there
are different "kinds" of death, defined for different pur-
poses, and hence that some people are "more dead" than
others. , , . , ,,
In many contexts, definitions are handmaidens to other
purposes lawmakers are seeking to achieve Rather than
askinc "what is death"? one might ask, "what difference
does it make whether somebody is dead"?* That question
has many answers, most of them familiar to everyone. Crim-
inal law (murder v. aggravated assault), tort law (wrongful
death), family law (the status of spouse and children), prop-
erty and estate law, insurance law (payment of life insur-
ance benefits and termination of health insurance pay-
ments), and tax law, as well as some actions and culturally
determined behaviors of family members, physicians, cler-
ics and undertakers axe all initiated by the determination
that a death has occurred. Were there good reason for one
branch or another of the law or one or another cultural in-
stitution to employ a different "definition" of death. logic
would not preclude such a step. But in fact, society has
found it desirable to employ a single standard for declaring
death in all these circumstances and no special-purpose
definitions have been seriously advanced. Calling the same
person "dead" for one purpose and "alive" for another
would engender nothing but confusion.5 Thus in setting
forth the law in statutory form, the wisest and most cau-
tious course (furthering the principle of incrementalism as
well) would be to adopt a rule recognizing the unity ot tne
concept of death. Such a "definition" of death can be ap-
plied in all appropriate circumstances; if a special need is
identified for acting on a different basis, a separate
status— other than that of being "dead"— could be defined
for that purpose.*
'Roger B. Dworkin. "Death in Context." 48 Ind. L. /. 623. 629
(1973).
'See, e.g. Fred Fabro. "Bacchiochi vs. Johnson Memorial Hospi-
tal" 45 Conn. Med. 267 (1981) chronicling the troublesome case of
Melanie Bacchiochi. On February 11. 1981 after repeated clinical
examinations confirmed by electroencephalography, physicians
found she had suffered irreversible loss of total brain function.
Her physician was unwilling to remove her from the respirator be-
cause of legal uncertainty since Connecticut's statute on "brain
death" applies only to organ transplantation. "It is ironic that if
the patient had been a donor, she could have been pronounced
dead on February 11 and the respirator could have been with-
drawn. Dead for transplantation, but not dead otherwise!" Id. at
268.
•Alexander M. Capron. "The Purpose of Death: A Reply to Profes-
sor Dworkin," 48 Ind. L.J. 640, 643-45 (1973); Capron and Kass,
op cit. at 107-08.
301
80 Defining Death: Chapter 5
Finally, since the proposed statute is intended to apply
in all situations, it ought not to be incorporated into a
state's Uniform Anatomical Gift Act (UAGA). Placing it
there would create the mistaken impression that a special
"definition" of death needs to be applied to organ trans-
plantation, which is not the case. (As a matter of fact, most
of the respirator-supported cases in which the brain-
oriented standard would be applicable are not potential do-
nors, as noted in Chapter 2.) Section 7(b) of the UAGA
makes the time of death a matter to be determined by the at-
tending physician; the proposed Uniform Determination of
Death Act specifies the grounds on which such a determi-
nation are made. Some people have expressed concern that
a determination of death in a potential organ donor might
be made by a physician with a conflict of interest, but the
UAGA specifies that the physician who determines that
death has occurred "shall not participate in the procedures
for removing or transplanting a part."66
* *- ■*-
"Uniform Anatomical Gift Act § 7(b), 8 Uniform Laws Annot.
608 (1972).
23-029 0-83-20
302
A'ri.SCiii-Uiivt C
Special Communication
Guidelines for the Determination of Death
Report ol the Medical Consultants on fhe Diagnosis ot Death to the President's Commission
(or the Study ol Ethical Problems in Medicine and Biomedical and Behavioral Research
The Guidelines set forth in this report repiesent the views ol the signatories is individuals,
they do not necessarily lellecl the policy ot any institution or prolessional association with which
any signatory is all.lialed Alihough the practice ol individual signatories may vary sightly,
s.gnaioi.es ag.ee on Ihe acceptability ol these guidelines Jesse Barbei. MD Don Becker. MO.
R.chaid Behrman. MD. JD. Donald R Benne'l MD. R.chaid Be.eslord. MD. JD. Reginald
B.cktord MD. William A Black, Jr. MD. Ben.em.n Boshes. MD. PhD. Philip Praunsie.n. MD. John
Bu..oughs. MD. JD Russell Butler. MD. John Ca.onna. MD. Shelley Chou, MD. PhD Kemp Clark.
MD Ronald C.anlord MD Michael Earnest MD. Aloert Ehle MD. Jack M Fein. MD. Sal Fiscma.
MD JD. Terrance G Furlow. MD. JD. Eli Goldensohn. MD: Jack G.abow MD. Phillip M Gieen.
MD. A«e Gren.ik MD. Charles E Henry. PhD. John Huphes. MD. PhD DM Howard Kaulman. MD.
Robert King MD Julius Kore.n. MD. Thomas W Langlitl. MD Cesare lombroso. MD Kevin M
Mclniyre MD JD Richard L Maslend MD. Don Harper Mills MD JD Gaelano Mol.nar. MD.
By. on C Pevehouse. MD. Lawrence H Pills. MD. A Bernard Pleel. MD. Fred Plum, MD. Jerome
Posner. MD. Dav.d Powner. MD. Richard Rovil. MD. Peler Salar. MD. Henry Sch.am. MD.
Edward Schlesmger MD Roy Selby. MD James Snyder. MD. Bruce F Sorenson. MD: Cary
Suler. MD. Barry Tha.p, MD. Fernando Torres. MD. A Earl Walker. MD. Arthur Ward. MD: Jack
Whisnant MD. Robert W.lkus MD. and Harry Zimmerman. MD
The p.epaianon ol this report was facilitated by Ihe Presidents Commission bul Ihe
guidelines have nol been passed on by Ihe Commission and are nol inlended as mailers lor
governmental review or adoption. .
THE ADVENT of effective artificial
cardiopulmonary support for severely
brain-injured persons has created
some confusion during the past sev-
eral decades about the determination
of death. Previously, loss of heart and
lung functions was an easily observ-
able and sufficient basis for diagnos-
ing death, whether the initial failure
occurred in the brain, the heart and
lungs, or elsewhere in the body. Irre-
For editorial comment
see p 2194.
versible failure of either the heart
and lungs or the brain precluded the
continued functioning of the other.
Now, however, circulation and respi-
ration can be maintained by means of
a mechanical respirator and other
medical interventions, despite a loss
of all brain functions. In these cir-
cumstances, we recognize as dead an
individual whose loss of brain func-
tions is complete and irreversible.
Repnnl reouesls to Joanne Lynn. MD. Assistant
Dneclor lo. Med.cal Slud.es, President's Commis-
sion tor Ihe Study ol Ethical Problems in Medicine
and Biomedical end Behavioial Research. Suile
665. ?000 K St NW. Washington. DC ?O006
To recognize reliably that death
has occurred, accurate criteria must
be available for physicians' use. These
now fall into two groups, to be applied
depending on the clinical situation.
When respiration and circulation
have irreversibly ceased, there is no
need to assess brain functions di-
rectly. When cardiopulmonary func-
tions are artificially maintained, neu-
rological criteria must be used to
assess whether brain functions have
ceased irreversibly.
More than half of the states now
recognize, through statutes or judicial
decisions, that death may be deter-
mined on the basis of irreversible
cessation of all functions of the brain.
Law in the remaining states has not
yet departed from the older, common-
law view that death has not occurred
until "all vital functions" (whether or
not artificially maintained) have
ceased. The language of the statutes
has not been uniform from state to
state, and the diversity of proposed
and enacted laws has created sub-
stantial confusion. Consequently, the
American Bar Association, the Amer-
ican Medical Association, the Na-
2184 JAMA. Nov 13. 1981— Vol 246. No. 19
tional Conference of Commissioners
on Uniform State Laws, and the Pres-
ident's Commission for the Study of
Ethical Problems in Medicine and
Biomedical and Behavioral Research
have proposed the following model
statute, intended for adoption in
every jurisdiction:
UNIFORM DETERMINATION OF
DEATH ACT
An individual who has sustained either
(II irreversible cessation of circulatory
and respiratory functions, or (2) irrevers-
ible cessation of all functions of the entire
brain, including the brain stem, is dead. A
determination of death musl be made i'
accordance wilh accepted medical stai.
dards.
This wording has also been endorsed
by the American Academy of Neurol-
ogy and the American Electroen-
cephalographic Society.
The statute relies on the existence
of "accepted medical standards" for
determining that death has occurred.
The medical profession, based on
carefully conducted research and ex-
tensive clinical experience, has found
that death can be determined reliably
by either cardiopulmonary or neuro-
logical criteria. The tests used for
determining cessation of brain func-
tions have changed and will continue
to do so with the advent of new
research and technologies The "Har-
vard criteria" (JAMA 1908,205:337-
340) are widely accepted, but ad-
vances in recent years have led to the
proposal of other criteria. As an aid
to the implementation of the pro-
posed uniform statute, we provide
here one statement of currently
accepted medical standards.
INTRODUCTION
The criteria that physicians use in
Diagnosis ot Death
303
determining that death has occurred
should (I) eliminate errors in classi-
fying a living individual as dead; (2)
alio* as few errors as possible in
classifying a dead body as alive; (3)
allow a determination to be made
without unreasonable delay; (4) be
adaptable to a variety of clinical
situations; and (5) be explicit and
accessible to verification.
Because it would be undesirable for
any guidelines to be mandated by
legislation or regulation or to be
inflexibly established in case law, the
proposed Uniform Determination of
Death Act appropriately specifies
only "accepted medical standards."
Local, state, and national institutions
and professional organizations arc
.encouraged to examine and publish
their practices.
The following guidelines represent
a distillation of current practice in
regard to the determination of death.
Only the most commonly available
and verified tests have been included.
The time of death recorded on a death
certificate is at present a matter of
local practice and is not covered in
this document.
These guidelines are advisory.
Their successful use requires a com-
petent and judicious physician, expe-
rienced in clinical examination and
the relevant procedures All periods
of observation listed in these guide-
lines require the patient to be under
the care of a physician. Considering
the responsibility entailed in the
determination of death, consultation
is recommended when appropriate.
The outline of the criteria is set
forth below in boldface letters. The
lightface text that follows each head-
ing explains its meaning In addition,
the two sets of criteria (cardiopulmo-
nary and neurological) are followed
by a presentation of the major com-
plicating conditions: drug and meta-
bolic intoxication, hypothermia,
young age, and shock. It is of para-
mount importance that anyone refer-
ring to these guidelines be thoroughly
familiar with the entire document,
including explanatory notes and com-
plicating conditions.
THE CRITERIA
FOR DETERMINATION OF DEATH
An individual presenting the find-
ings in cifhvr section A (cardiopulmo-
nary) or section B (neurological) is
dead In either section, a diagnosis of
death requires that both cessation of
functions, as set forth in subsection 1,
and irreversibility, as set forth in
subsection 2, be demonstrated.
A. An individual with irreversible ces-
sation of circulatory and respiratory
functions is dead.
I. Cessation is recognized by an
appropriate clinical examination.
Clinical examination will disclose
at least the absence of responsive-
ness, heartbeat, and respiratory ef-
fort. Medical circumstances may re-
quire the use of confirmatory tests,
such as an ECG.
2. lrrc\erstbitity is recognized b\ per-
sistent cessation of functions during an
appropriate period of observation and/or
trial of therapy.
In clinical situations where death is
expected, where the course has been
gradual, and where irregular agonal
respiration or heartbeat finally
ceases, the period of observation fol-
lowing the cessation may be only the
few minutes required to complete the
examination. Similarly, if resuscita-
tion is not undertaken and ventricu-
lar fibrillation and standstill develop
in a monitored patient, the required
period of observation thereafter may
be as short as a few mintues. When a
possible death is unobserved, unex-
pected, or sudden, the examination
may need to be more detailed and
repeated over a longer period, while
appropriate resuscitative effort is
maintained as a test of cardiovascular
responsiveness. Diagnosis in individu-
als who are first observed with rigor
mortis or putrefaction may require
only the observation period necessary
to establish that fact.
B. An individual v»iih irreversible ces-
sation of all functions of the entire brain,
including the brain stem, is dead. The
"functions of the entire brain" that
are relevant to the diagnosis are
those that are clinically ascertain-
able. Where indicated, the clinical
diagnosis is subject to confirmation
by laboratory tests, as described in
the following portions of the text.
Consultation with a physician experi-
enced in this diagnosis is advisable.
1. Cessation is recognized when evalu-
ation discloses findings of a and b:
s. Cerebral functions arc absent, and
There must be deep coma, that is,
cerebral unreceptivily and unrespon-
sivity. Medical circumstanres may
require the use of confirmatory stud-
ies such as an EEC or blood-flow
study.
b. brain stem functions are absent.
Reliable testing of brain stem re-
flexes requires a perceptive and expe-
rienced physician using adequate
stimuli. Pupillary light, corneal, ocu-
locephalic, oculovestibular, oropha-
ryngeal, and respiratory (apnea) re-
flexes should be tested. When these
reflexes cannot be adequately as-
sessed, confirmatory tests are recom-
mended.
Adequate testing for apnea is very
important. An accepted method is
ventilation with pure oxygen or an
oxygen and carbon dioxide mixture
for ten minutes before withdrawal of
the ventilator, followed by passive
flow of oxygen. (This procedure
allows PaCO- to rise without hazard-
ous hypoxia.) Hypercarbia adequately
stimulates respiratory effort within
30 seconds when Paco; is greater than
60 mm Hg. A ten-minute period of
apnea is usually sufficient to attain
this level of hypercarbia. Testing of
arterial blood gases can be used to
confirm this level. Spontaneous
breathing efforts indicate that part of
the brain stem is functioning.
Peripheral nervous system activity
and spinal cord reflexes may persist
after death. True decerebrate or
decorticate posturing or seizures are
inconsistent with the diagnosis of
death.
2. IrrcMTsibilily is recognized when
evaluation discloses findings of a and b
and c:
a. The cause of coma is established
and is sufficient to account for the loss of
brain functions, and . . .
Most difficulties with the determi-
nation of death on the basis of neuro-
logical criteria have resulted from
inadequate attention to this basic
diagnostic prerequisite. In addition to
a careful clinical examination and
investigation of history, relevant
knowledge of causation may be
acquired by computed tomographic
scan, measurement of core tempera-
ture, drug screening, ERG, angiogra-
phy, or other procedures.
b. Ihr possibility of recovery of any
brain functions is excluded, and . . .
The most important reversible con-
ditions are sedation, hypothermia,
neuromuscular blockade, and shock.
JAMA. Nov 13. 1981— Vol 246. No 19
Diagnosis ot Death 2185
304
In I he unusual circumstance where a
sulliiirnt ransr rannot be estab-
lished, irreversibility ran lie reliably
inferred only afler extensive evalua-
tion for ilrui! intoxication, extended
observation, and other testing A
determination that blood flow to the
brain is absent can be used to demon-
strate a sufficient and irreversible
condition.
c. the cessation of all brain functions
persists for an appropriate period of
oh-cnatinn and/or trial of therapy.
Even when coma is known to have
started at an earlier time, the absence
of all brain functions must be estab-
lished by an experienced physician
at the initiation of the observation
period. The duration of observation
periods is a matter of clinical judg-
ment, and some physicians recom-
mend shorter or longer periods than
those niven here.
Except for patients with drug
intoxication, hypothermia, young age,
or shock, medical centers with sub-
stantial experience in diagnosing
death neurologically report no eases
of brain functions returning following
a six-hour cessation, documented by
clinical examination and confirmato-
ry EEC. In the absence of confirma-
tory tests, a period of observation of
at least 12 hours is recommended
when an irreversible condition is well
established. For anoxic brain damage
where the extent of damage is more
difficult to ascertain, observation for
2J hours is generally desirable. In
anoxic injury, the observation period
may be reduced if a test shows cessa-
tion of cerebral blood flow or if an
EEG shows electrocerebral silence in
an adult patient without drug intoxi-
cation, hypothermia, or shock.
Confirmation of clinical findings by
EEG is desirable when objective doc-
umentation is needed to substantiate
the clinical findings. Electrocerebral
silence verifies irreversible loss of
cortical functions, except in patients
with drug intoxication or hypother-
mia. (Important technical details are
provided in "Minimal Technical Stan-
dards for EEG Recording in Sus-
pected Cerebral Death" [Guidelines in
EEG 19ltn. Atlanta, American Elec-
troencephalograph'^ Society, 1980.
section 4, pp 19-2-1].) When joined
with the clinical findings of absent
brain stem functions, electrocerebral
silence confirms the diagnosis.
2186 JAMA. Nov 13. 1981-Vol 246. No. IB
Complete cessation of circulation to
the normnthrrmir adult brain for
more than ten minutes is incompati-
ble with survival of brain tissue.
Documentation of this circulatory
failure is therefore evidence of death
of the entire brain. Knur- vessel intra-
cranial angiography is definitive for
diagnosing cessation of circulation to
the entire brain (both cerebrum and
posterior fossa) but entails substan-
tial practical difficulties and risks.
Tests are available that assess circu-
lation only in the cerebral hemi-
spheres, namely radioisotope bolus
cerebral angiography and gamma
camera imaging with radioisotope
cerebral angiography. Without com-
plicating conditions, absent cerebral
blood flow as measured by these tests,
in conjunction with the clinical deter-
mination of cessation of all brain
functions for at least six hours, is
diagnostic of death.
COMPLICATING CONDITIONS
A. Drug and Metabolic Intoxication. —
Drug intoxication is the most serious
problem in the determination of
death, especially when multiple drugs
are used. Cessation of brain functions
caused by the sedative and anesthetic
drugs, such as barbiturates, benzodi-
azepines, meprobamate, methaqua-
lone, and trichloroethylene, may be
completely reversible even though
they produce clinical cessation of
brain functions and electrocerebral
silence. In cases where there is any
likelihood of sedative presence, toxi-
cology screening for all likely drugs is
required. If exogenous intoxication is
found, death may not be declared
until the intoxicant is metabolized or
intracranial circulation is tested and
found to have ceased.
Total paralysis may cause unre-
sponsiveness, areflexia. and apnea
that closely simulates death. Expo-
sure to drugs such as neuromuscular
blocking agents or aminoglycoside
antibiotics, and diseases like my-
• asthenia gravis are usually apparent
by careful review of the history- Pr0"
longed paralysis after use of succinyl-
choline chloride and related drugs
requires evaluation for pseudocholin-
esterase deficiency. If there is any
question, low-dose atropine stimula-
tion, electromyogram. peripheral
nerve stimulation, EEG, tests of
intracranial circulation, or extended
observation, as indicated, will make
the diagnosis clear.
In drug-induced rnma, EEG arl"i-
ly may return or persist while >
patient remains unresponsive, nnd
therefor.' the EEG may be an impor-
tant evaluation along with extended
observation. If the EEG shows elec-
trocerebral silence, short latency au-
dilory or somnloscnsory-cvokcd po-
tentials may be used to test brain
stem functions, since these potentials
are unlikely In he affected by drugs.
Some severe illnesses (eg, hepatic
encephalopathy, hyperosmolar coma,
and preterminal uremia) ran cause
deep coma. Before irreversible cessa-
tion of brain functions can be deter-
mined, metabolic abnormalities
should be considered and, if possible,
corrected. Confirmatory tests of cir-
culation or EEG may be necessary.
B. Hypothermia.— Criteria for reli-
able recognition of death are not
available in the presence of hypother-
mia (below 32.2 °C core temperature).
The variables of cerebral circulation
in hypothermic patients are not suffi-
ciently well studied to know whether
tests of absent or diminished circula-
tion are confirmatory. Hypothe-
can mimic brain death by ordi.
clinical criteria and can protect
against neurological damage due to
hypoxia. Further complications arise
since hypothermia also usually pre-
cedes and follows death. If these
complicating factors make it unclear
whether an individual is alive, the
only available measure to resolve the
issue is to restore normolhermia.
Hypothermia is not a common cause
of difficulty in the determination of
death.
C. Children.— The brains of infants
and young children have increased
resistance to damage and may recover
substantial functions even after ex-
hibiting unresponsiveness on neuro-
logical examination for longer periods
compared with adults. Physicians
should be particularly cautious in
applying neurological criteria to de-
termine death in children younger
than 5 years.
D. Shock.— Physicians should also
be particularly cautious in applying
neurological criteria to determine
death in patients in shock becau; )e
reduction in cerebral circulation ^an
render clinical examination and labo-
ratory tests unreliable.
Diagnosis of Death
305
5di5t'oiriaIls
Epidermolysis Bullosa Research Association Guidelines for the Determination of Death
Voluntary health associations have made enormous contribu-
tions to the control of many major diseases The National
Tuberculosis Association (NTA). established in I90V was one
of the first to be organized, and others that followed patterned
their organisational structure and activities after the NTA. The
major strength of voluntary health groups is the cooperative
effort and understanding they create between physicians and
lav persons who together share responsibilities on governing
boards and committees.
The main activities of volunrary health associations are
support of research, public education service to patients,
support of professional education, and advice ro government
on legislation and reputation The control of tuberculosis and
the conquest of poliomyelitis, advances in the prevention and
tieatment of heart disease, and the success of renal dialysis and
transplantation are examples of what can be accomplished by
voluntary health agencies. These successes have served to
encourage the formation of other groups whose members have
a special concern for a disease that has afflicted a family
member or friend. Most of the voluntary health groups
organized in recent years have been small in size and have
directed theit attention to relatively uncommon diseases. These
otganizations face an uphill battle for recognition, are unable to
raise large sums of money to support their activities, and often
are battling against diseases that will not yield to current
research technology. Ofien, however, the greater the challenge,
the greater the enthusiasm of those who are being challenged.
A recent addition to the voluntary health movement is the
Epidermolysis Bullosa Research Association. Although the
prevalence of epidermolysis bullosa in the United States is not
precisely known, the new association has identified more than
1.500 cases and believes that through increased research this
distressing disorder may either be prevenred or more defini-
tively treated. Epidermolysis bullosa is a group of inherited skin
disorders, characterized by the formation of blisters that follow
mild trauma. The genetic basis for these disorders make them a
lifelong problem for those unfortunate enough to inherit the
disorder. Like other chronic diseases, it arouses greater concern
and interest in the establishment of a society than do acute
self-limited diseases.
The Epidermolysis Bullosa Research Association is interested
in receiving reports of research on epidermolysis bullosa, in
recruiting both lay and medical professionals to its ranks, and,
of course, in receiving donations to advance its cause.
Interested persons should contact the executive director of the
association at 29V> Avenue W. Brooklyn, NY 11229-
U pi Haw R BaHCLAV. MD
Add'esi atMonat communication* to Ihe Editor. S35 N Dearborn Si.
CnicaQO. H. 6O810.
The report on Guidelines for the Determination of Death*" in
this issue (p 21H4) is a landmark document with far-reaching
medical, ethical, and legal implications. It is a summary of
currently accepted medical practices for the determination of
death, both cardiorespiratory and neurological, although the
majority of the report is devoted to the diagnosis of
neurological, or brain, death Physicians from numerous
specialities contributed to the drafting of this report, which was
coordinated by the stalT of the President's Commission for the
Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research. These guidelines are included as an
appendix to the more comprehensive report by the President s
Commission on "Defining Death: A Report on the Medical.
Legal and Ethical Issues in the Determination of Death" (this
entire report was approved by the President's Commission and
sent to the President on July 9. 1981).
Until now, the most widely accepted standards for brain
death in the United States have been the criteria developed by
the Ad Hoc Committee of the Harvard Medical School to
Examine the Definition of Brain Death, published in JAMA in
196S (205.337-340). These new guidelines are an update of
currently accepted standards in the light of a gieat body of
clinical experience accumulated since the original report of the
Harvard Committee, and the development and refinement of
new technologies in the laboratory confirmation of the
diagnosis.
This report is important primarily because so many physi-
cians were able to reach a consensus on a common set of
guidelines, even though there were (and still are) differences of
opinion on specific aspects of the criteria, and the signatories
were aware of the ethical and legal implications of developing a
set of national standards For this many prnsioans from the
fields of neurology, neurosurgery, electroencephalography,
critical care medicine, anesthesiology, and legal medicine to
reach a consensus is truly a remarkable achievement, of which
the medical profession can be proud. Efforts such as this
suggest that physicians have recognized the need fot coopera-
tion in developing standards in areas of controversy. In the next
few decades, it will become more apparent to the medical
community that it will need to take positions on even more
controversial issues Future statements will cover such areas as
organ donation, "do not resuscitate" orders, and guidelines for
the termination of treatment of "hopelessly ill" patients.
This report is not the final word on standards for
determining death, but it is an important step forward in
society's attempts to deal with bioethical dilemmas brought
about by advances in medical technology, and it further
reinforces the view that the medical profession must and will
continue to assume a leadership role in these endeavors.
VX'ntiAM R Baici-ay. MD
2194 JAMA. Now 13. 1981— Vol 246. No. 19
Editorials
306
ATTACHMENT D
Excerpts from
Catastrophic Diseases:
Who Decides What?
A Psychosocial and Legal A nalysis
of the Problems Posed by Hemodialysis
and Organ Transplantation
Jay Katz and Alexander Morgan Capron
Russell Sage Foundation New York
1975
307
196 Stages of Decisionmaking
* * +
4. Selection of Donors
One resource for the modern treatment of the catastrophic illnesses dis-
cussed here is unique: organs for transplantation. Since this resource is so
unusual, we have chosen to treat it separately from the discussion of those
resources (including artificial organs) whose supply is largely dependent
on economic factors. We begin with a discussion of formulating policy on
how to obtain organs (which is brief in light of the similarity of the issues
to the questions discussed concerning the distribution of resources); this is
followed by sections in which donations from living and dead persons are
discussed.
a. Policies on Obtaining Organs. As is true for other resources, the cen-
tral fact about transplantable organs is their scarcity. Consequently, well
thought-out policies are required to increase the supply. The least expensive
and most readily available sources consists of cadaver organs, primarily
from accident victims."9
Prior to 1968, organ donation in this country was complicated by anach-
ronistic legal provisions designed to prohibit graverobbing and by the
absence of clear rules specifying the interests which could exist in a dead
body and who could exercise them. The promulgation of the Uniform
Anatomical Gift Act (UAGA) in the summer of 1968, and its subsequent
adoption by all states and the District of Columbia, went a long way
to cut through the fog which had enshrouded the subject. Under the Act,
a person has the right during his lifetime to permit or forbid the use of his
organs for purposes of treatment, research, and teaching after his death;
if he fails to act, the organs can be donated by his next-of-kin (according
to an order of priority established by the Act) after the person has died.
The donee can be an individual patient or a physician or hospital, with the
latter being free to use the organs as needed locally or elsewhere."0
88 See, e.g., Dukcminicr, Supplying Organs for Transplantation, 68 Mich. L. Rev.
811, 814-15 (1970) — citing statistics that 10,000 kidney transplants could be per-
formed per year in this country if immunological problems are solved, and that
there are approximately 10,600 suitable cadaver kidneys available each year.
80 Thus, the organ-typing and patient-matching program operated for kidneys by
Dr. Paul Terasaki's group at U.C.L.A. provides for hospitals to share the kidneys
available to them on a nationwide basis, for which they receive "credits" that put
them higher on the list for a cadaver organ the next time a "compatible" one is
nvailable. See Terasaki, Wilkinson Sc McClelland, National Transplant Communica-
308
Formulation of Policy 197
In effect, the UAGA creates a "market" system with a zero price tor
organs (although the donee, by custom or contract, sometimes pays the
cost of the donor's final hospitalization as well as the expense of removing
the organ). The system relies on individual choice, with a leading role
being taken by physicians who in most circumstances are the initiators of
the donation. While no reliable figures arc yet available to establish the
impact the UAGA has had on the level of donation, it is generally agreed
that not enough organs are being donated to meet present need, and some
commentators doubt that the current method will ever produce sufficient
donations.00
In its place a number of alternatives are possible. The first would simply
add a payment procedure to UAGA-type organ transfers. Although the
Act speaks of "donations," its terms do not prohibit sales as well. It is un-
certain, however, that individuals would express much interest in an offer
to sell a right to one's organs after death (with present payments), since
the purchaser would have little assurance that the.seller would die at a time
and place or in a manner conducive to useful organ donation."1 It would
be possible, however, to make payment to a terminally ill patient, or, after
his death, to his estate. Sales of this type might, however, pose serious
psychological threats for dying patients and impose unwanted pressures on
the next-of-kin.
The sale of "spare" organs by living donors for immediate delivery raises
fewer logistical and psychological problems. Jesse Dukeminier, Jr., found
"no statute in an American state expressly prohibiting the sale of a spare
organ"02 but nevertheless suggested that making a payment to a live donor
raises the prospect of civil and criminal liability for the physician removing
the organ. While we do not share his concern on these points, we doubt
that payment is wise for policy reasons. As Richard M. Titmuss has argued
with considerable force, a major fault with the American system of collect-
ing blood is that the existence of paid donors discourages volunteers.*3
While all the data necessary to support his argument are not available, the
tions Network, 218 J. A.M. A. 1674 (1971). This type of arrangement is discussed in
greater detail in Chapter Nine.
9nSee, e.g., Sanders & Dukeminier, note 53 supra, at 394 ff.\ Note. Compulsory
Removal of Cadaver Organs, 69 Colum. L. Rev. 693 (1969) [hereinafter cited as
Compulsory Removal].
01 If the purchaser is the state (or other national organization) the prpblem of
location is reduced somewhat. Were A to buy the right to fl's organs at the time of
the latter's demise, A would not want B to die in a distant city where his organs
would do A no good. Were the government to purchase the organs, it might be less
concerned, since they could probably be put to use in any of a number of locations.
82 Dukeminier, note 88 supra, at 850.
»3 R. Titmuss. The Gift Relationship: From Human Blood to Social Pouar
(1971).
309
198
Stages of Decisionmaking
danger that payment for organs (kidneys in particular) would decrease
"altruism" among donors and their next-of-kin is one reason for not per-
mitting payment for organs.0* Furthermore, since the poor would probably
sell organs disproportionately, this system would probably be subject to a
charge of "exploitation."
An alternative which is likely to increase the supply would be to presume
that organs may be removed from any corpse unless a prior objection has
been raised. In the proposal made by Dukeminier and Sanders," objection
could be raised "either by the decedent during his life or by his next-of-kin
after the decedent's death."" Giving a role to the relatives is intended to
permit them to protect their religious beliefs and is also a recognition that
most transplanters would hesitate to go ahead if relatives were to claim that
the deceased objected to the removal of his organs— even if they could
produce no "proof" of this fact within the short time in which organs
remain "viable" after a person's death. Yet as others have noted, by requir-
ing the transplanters to make sure that the relatives do not object, the
Dukeminier-Sanders plan places as much of a burden (in terms of effort to
secure consent and danger of delay) on the system as the existing pro-
cedure.87 The debate thus turns on whether society would find a system
of choosing to give ("opting-in") or choosing not to give ("opting-out")
more acceptable.
If the right to object were to be left solely with the person whose organs
are to be removed, the process of obtaining organs could be greatly simpli-
fied and the number of available organs would doubtless increase greatly.
The presumption in favor of routine salvaging would have to be widely
publicized and "opting-out" made as simple as sending a preaddressed post-
card to a central computer registry which could be consulted by a surgeon
prior to organ removal." Before the enactment of the UAGA, questions
"If the government purchases the organs, would it do so in every case (at a high
cost in resources thus diverted from lifesaving therapy)? If not, on what basis would
it decide when to pay and when not? (If on the basis of wealth of the corpse, why
not employ more direct means of income redistribution?) If individuals were to buy
the organs, it would amount to the creation of a market system on the distribution
side, with all the problems discussed earlier in subsection 3(c)[i].
" See Sanders & Dukeminier, note 53 supra, at 410-13; Dukeminier, note 88 supra,
at 837-42; Dukeminier & Sanders, Organ Transplantation: A Proposal for Routine
Salvaging of Cadaver Organs, 279 New Eno. J. Med. 413 (1968).
89 Dukeminier, note 88 supra, at 837.
"Sadler, Sadler. Stason & Stickcl: Transplantation: A Case for Consent, 280
New Eno. J. Med. 862 (1969).
" A central renal registry was part of a plan, along the lines outlined here, pro-
posed by the Advisory Oroup on Transplantation Problems appointed by the Health
Minister* in Great Britain and chaired by Sir Hector MacLennan, M.D. See Advice
310
Formulation of Policy 199
might have arisen whether such an arrangement would give sufficient atten-
tion to the next-of-kin's rights over the corpse. The UAGA made clear,
however, that these rights, if they ever existed, are subject to alteration or
abolition by the legislature; the decedent's determination to give his organs
for transplantation or other use is binding, despite any objection on the
part of his relatives. It seems equally valid to reduce relatives' control so
as to permit removal of the organs unless a deceased had objected. A more
difficult question is raised if the relatives claim an objection on religious
grounds. On the one hand, the deceased was in a position to forbid use of
his body if he shared his relatives' view. On the other hand, the relatives
may claim that their religion does not make requirements about the burial
of one's own body but about those of one's kin. This argument may prove
too much, however. On this logic, could not the relatives equally well claim
a "right" to control any body, whether the deceased be a relative or a
member of their church or not?89
A more far-reaching restriction on the right to object could abolish this
right altogether, making donation compulsory,100 as autopsies already are
under certain conditions.101
Moreover, if organs are treated as property of the decedent, the decedent
may have no power to order destruction of his organs by burial or cremation
so long as the organs have value. It has been held in a number of cases that
a direction to destroy one's own property at death is against public policy
and is therefore void.102
While these and other analogies suggest that the public interest in saving
lives through transplantation is great enough to justify making organ re-
moval automatic (when medically useful), the policy issues (such as impact
of this method on the emotions and personal feelings of the survivors)
need to be openly debated before legislatures take such a step. Furthermore,
since the donor is also deprived of the right to object, the religious con-
siderations mentioned previously would loom much larger. If it is possible
for the government to "accommodate its purpose [i.e., saving lives] by
on the Question of Amending the Human Tissue Act 1961 (Cmnd. 4106) National
Health Servjte (1969). Their recommendations were embodied in a Renal Trans-
plant Bill, which was not ndopted.
"9 If the deceased had been a member of their church, he could have chosen to
"opt-out" of donation himself.
100 See Compulsory Removal, note 90 supra.
101 See, e.g., Young v. College of Physicians & Surgeons, 81 Md. 358, 32 A. 177
(1895); Sturgeon v. Crosby Mortuary, Inc., 140 Neb. 82, 299 N.W. 378 (1941).
102 Dukeminier, note 88 supra, 834. ■
311
Stages of Decisionmaking
means which do not impose such a burden,"103 then compulsory removal
of cadaver organs would ran afoul of the First Amendment.
The only way to establish the need for a compulsory system, in other
words, is to try less restrictive systems and see if they will produce an ade-
quate supply. We believe that, for the moment, present policy, as embodied
in the Uniform Anatomical Gift Act, ought to be given a fair trial first.
Studies should, however, be conducted to determine whether the Act is
adequately facilitating donations and whether any of its features should
be revised. The real need for a change in policy on the obtaining of organs
will arise when and if transplantation technology overcomes the problem
of rejection and establishes itself as a highly successful form of therapy.
If, under these circumstances, it appears that a change in procedure is
warranted, prime consideration should be given to the "opting-out" system
proposed by the MacLennan committee in Great Britain.104 While it might
be objected that in the case of a patient who had not opted-out, the attend-
ing physician would feel unwarranted pressure to forego necessary treat-
ment so as to speed death, it seems likely that the very much greater supply
of organs that could be expected under such a system would on the whole
reduce the pressure in each individual case.
b. Donation by Living Individuals. Thus far the policies under discussion
have been ones which require a societal judgment, and we have spoken in
terms of legislative action. As we turn now to issues that have been dealt
with largely through the private ordering of physicians, hospitals, patients,
donors, and their families, the question arises whether a need exists for
more broadly representative groups to engage in formulating policy more
openly and explicitly. The following discussion will treat separately the do-
nation of paired and unpaired organs, with primary attention devoted to
the formulation of policies concerning the former.
i. paired organs. As described in Chapter Four, living donors have
been an important source of kidneys for transplantation since the earliest
days of the procedure. Patients' relatives were the donors in more than 30
percent of all kidney grafts to date and they continue to provide an impor-
tant source of organs. Unrelated living donors, by contrast, gave 14.5 per-
cent of the kidneys in the 14 years prior to 1967 for which records are
available, but have not been used as donors at all since 1969. 105 Since the
103 Braunficld v. Brown, 366 U.S. 599, 607 (1961).
104 See note 98 supra.
10*See Advisory Committee to the Renal Transplant Registry, Ninth Report of
the Human Renal Transplant Registry, 220 J.A.M.A. 253 (1972). In addition to the
122 organs included in this figure for 1953-1966, and 144 to date, there have been
to date 31 donations by spouses, who are also "unrelated" in the genetic sense. On
the other hand, Dr. Carl Fellner concludes on the basis of the early reports (which
contained a finer breakdown of donor categories) that more than half of the kidneyi
312
Formulation of Policy 201
failure to employ this source does not stem from any ready availability
of organs from other sources (as has already been noted), it must be a
result of transplant surgeons' choice — and, in fact, this situation provides
a valuable illustration of policymaking by physicians.
The reasons physicians have difficulties in using unrelated donors are not
hard to fathom. Outside of research settings, physicians are not used to
dealing with persons who will derive no therapeutic benefit from an inter-
vention. Although some transplanters made use of live, unrelated donors
in the early days of renal grafting, perhaps because less was known about
how to keep cadaver organs viable and because the experimental nature of
the procedure meant that all (recipients as well as donors) were taking
risks, gradually there emerged a "distrust and suspicion toward the moti-
vation of such [unrelated live] donors and a definite repugnance concern-
ing their use."""1 Dr. Harrison Sadler and his colleagues discovered from
a careful study of 18 unrelated donors that the primary motive for their
donation was not "the satisfaction of drives or the discharge of infantile
impulses, but the very personal area of self-identity, a self-ideal quite un-
conscious to them at the time."107 In spite of their published findings, the
Sadler group "continued to hear the remark, 'they [unrelated donors] must
be crazy to do such a thing, no matter what you say — they are per-
verted'."108
This kind of thinking on the part of transplanters has rarely been ex-
pressed in formal rules or statements.109 Although no live related renal
donors have been used for three years in the United States, the policy of
physicians as publicly stated does not bar such employment and the Inter-
national Transplantation Society even acknowledges "that the wish to do-
nate an organ need not be a sign of mental instability."110 The deviation of
from unrelated donors were "free kidneys" obtained from persons who had to under-
go a nephrectomy for reasons unrelated to transplantation. Fellner, Altruivm Re-
visited: The Genetically Unrelated Living Kidney Donor (consultant's memorandum),
at 4 (1972) [Appendix E].
infl Sadler, Davison, Carroll, & Kountz, The Living Genetically Unrelated Kidney
Donor, 3 Seminars in Psych. 86 (1971). See also pp. 93-94 supra.
107 Sadler, Summary Notes on a Clinical Decision-Making Model (consultant's
memorandum), at 1 (1972) [Appendix HJ.
108 Id.
,nnThe French position, as expressed before the National Academy of Medicine in
October 1970 by Dr. J. Dormonl, is that "the donor must ... be chosen exclusively
from among the close relatives of the recipient." Dormont, Les Probltmes Moraux de
la Transplantation d Organs, 154 BULL. Acad. NAT. M.ED. (Paris) 623 (1970).
110 Hamburger, et al., A Declaration of the International Society of Transplanta-
tion, 12 Transplant. 77 (1971). Cf. Bar Council Report on Organ Transplants, 3
Brit. Mf.d. J. 716 (1971) — approving organ removal from a mentally competent
donor over 16 years of age who ha9 given his written consent after he had been fully
advised of the risks.
313
202 Stages of Decisionmaking
practice (or one could say, tacit medical policy) from official policy is,
at the moment, not too distressing because the success rate of kidney grafts
from unrelated donors is still below that of any other category (including
cadavers), since present tissue typing methods apparently do not permit
the identification of certain important antigenic factors which are absent
(although undetected) in related donors such as siblings. But, as Dr.
Fellner notes,
it is only a question of time before tissue matching with the help of HL-A
antigen typing, and other typing systems yet to be found, will have progressed
to the point where, for organ transplantation purposes, the equivalent of a
monozygotic twin could easily be pinpointed in the population at large.1 n
Before such time arises, it will be necessary for policy to be formulated
on this subject making clear whether genetically unrelated donors should
be accepted. This is a question which cannot be resolved by physicians
alone. It concerns such issues as: (1) Does society have any interests in
preventing a person from making a gift (or, as discussed previously, a sale)
of an organ if that creates risk to his own life? (2) What level of risk is
acceptable? (3) What level of "success" of the transplant is necessary, if
any, to justify the donor's risk? (4) How does the availability of organs
from other sources, such as cadavers or living related donors, affect the
decision? (5) What is the relevance of different success rates between living
unrelated donors and other sources? And (6) what is the relevance of
surgeons' beliefs with respect to the use of organs from unrelated donors?
While these questions must be addressed by a public policymaking body,
such as a special advisory group to the National Institutes of Health or to
legislatures, it is our opinion that evidence already exists to indicate that
there are reasons of policy, if not of medicine, to prefer unrelated rather
than related donors. Unlike Sadler's findings about unrelated donors (who
were accepted only if they persisted on their own initiative in their offer,
over a number of months and without encouragement from the transplant
center), there are many indications that related donors were not true
volunteers, participating of their own free will. One study showed that
such donors did not reach their decisions in the thoughtful, rational manner
which had been assumed by the theorists on consent.112 Moreover, despite
physicians' attempts to protect the donor from undue pressures, it is ap-
parent that veiled or even open pressure from family members as well as
1,1 Fellner, Altruism Revisited, at 1 (1972) [Appendix E].
112 Fellner & Marshall, Kidney Donors: The Myth of Informed Consent, 126 Am. J.
Psychiatry 1245 (1970); see also Fellner & Marshall. Twelve Kidney Donors, 206
J. A.M. A. 2703 (1968); notes 27-36 It accompanying text supra.
314
Formulation of Policy 203
unconscious feelings of obligation and other psychological factors weigh
heavily on family donors.113
In most instances, no real decision-making problem existed for the donor.
Most commonly, he stated that he must give to save the life of the potential
recipient or he could not face himself. In a sense, he is "called. " It is not
always a call about which he is enthusiastic, but it is one which he believes
he is unable to refuse.114
From such observations by others and from a review of his own interviews
with donors (who typically declared "I had to do it"), Dr. Fcllner argues
that "most donors do not act out of pity or altruism but out of a feeling
that they have to do this for their own sake."110
If this analysis is correct, then physicians appear to have adopted an
informal policy which excludes people as donors whom the physicians
believe act from "improper" motives and must be "crazy," when in fact
those people's donations are a far more "voluntary" expression of their
own choice and a more "genuine" reflection of a well integrated person than
arc the donations made by family donors. There is thus a need for others,
who themselves arc not so emotionally involved as the transplanters clearly
are, to participate in the formulation of policy in this area.
Some additional light on decisionmaking with respect to live donors is
thrown by contrasting medical policy on unrelated donors with that on the
use of related donors who are incapable of giving valid consent. In most
circumstances, no thought would be given to using such donors; however,
where a child in renal failure has an identical twin, physicians favor use of
the twin as an organ donor since the prognosis is so favorable.11 * Since
minors117 cannot themselves consent to operations, and since it is believed
that parents or guardians cannot give permission when the procedure is not
118 See, e.g., Simmons, Hickey, Kjellstrand, & Simmons, Family Tension in the
Search for a Kidney Donor, 215 J. A.M. A. 909 (1971); Crammond. Renal Homo-
transplantation: Some Observations on Recipients and Donors, 133 BRrr. J. Psych.
1223 (1967).
114 Eisendrath. Gultman & Murray, Psychological Considerations in the Selection
of Kidney Transplant Donors, 129 Surg. Gynec & Obstet. 243 (1969).
lir'Fellner, Altruism Revisited, at 8 (1972) [Appendix E]. He also belieNes that
these donors experience a feeling of power from their act and gain in self-esteem.
1.6 Since 1967, one- and two-year survival rate for monozygotic twin transplants
has been 100 percent. Ninth Registry Report, note 105 supra, at 256. Dialysis is not
favored as a method of treating children with kidney disease because of the adverse
effects of the treatment and dietary regime on growth and possibly on the child's
psyche.
1.7 Customarily defined as persons under 21, although most states have now made
18 the age of majority.
315
204 Stages of Decisionmaking
intended to benefit the child, n8 refuge has been taken in court actions. In
these cases, the judiciary has uniformly approved the physicians' and par-
ents' request for permission to transplant a kidney from the well to the
ailing twin. In the first cases,110 the children were teenagers, who one may
assume were old enough at least partially to comprehend the contemplated
operation; thus, their consent and agreement to having their kidneys re-
moved properly played a role in the courts' reasoning. More recent cases
have involved much younger children.120 Here, the weight of the decisions
has been cast onto the argument that the child-donor does receive a benefit
by avoiding the psychic harm which would arise from the loss of the twin.
This seems to be ar^attempt on the part of the judiciary to avoid having to
confront the policy question of using nonconscnting individuals as donors.
Some commentators, such as David Daube, have been sharply critical of
the present practice.121 There is a pressing need to engage in an open policy
debate on this subject, which will touch many of the same questions of
comparative benefits and risks set forth previously in the discussion of un-
related donors and which will also raise the whole issue of the use of chil-
dren in medical research. This debate should eventually lead to proposals
by professional and legislative bodies alike as to the policies which are to
guide these research activities.
ii. unpaired organs. The donation of an unpaired organ is tantamount
to taking one's life. For this reason, we know of no situation in which such
n donation has been permitted. Paul Blachly has suggested, however, that
persons engaged in "suicide-prevention" discuss with those intent on sui-
,,B Although, as was discussed in Chapter Six, the kidney cases in minors are
usually taken to exemplify the problem of obtaining valid permission for a nonbene-
ficial intervention, they involve an additional element: namely, that the parents face
o conflict-of-interest in desiring to help the ailing child through a donation by the
well child. This conflict may becloud the parents' judgment more than would be
true in other nonbeneficial (research) interventions.
1,9 The earliest cases are three unreported Massachusetts decisions growing out of
operations performed at the Peter Bent Brighnm Hospital. The cases are discussed in
Curran. A Problem of Consent: Kidney Transplantation in Minors, 34 N.Y.U.L. Rev.
891 (1959).
»20 Hart v. Brown. 289 A. 2d 386 (Conn. Si'per. Ct. 1972)— approval of transplant
in seven-year-old twin girls. In Strunk v. Strunk, 445 S.W. 2d 145 (Ky. 1969), the
donor was a 27-year-old inmate of a state mental institution; he was found to have
a "mental age of approximately six years."
121 "Children should on no account be donors, and there should be no cheating by
maintaining . . . that the child would suffer a trauma if he were not allowed to give
his twin a kidney or whatever it might be." Daube, Transplantation: Acceptability oj
Procedures and the Required Legal Sanctions, in Ethics in Medical Progress: With
Special Reference to Transplantation 188. 198 (G.E.W. Wolstenholme & M.
O'Connor eds. 1966) [hereinafter cited as Medical Progress].
316
Formulation of Policy 205
cide that they donate a paired organ instead.122 Blachly argues that since
potential suicides usually involve depression and feelings of unworthiness,
the opportunity to help others in a dignified fashion may be very thera-
peutic. Similarly, the attention given a donor has been viewed as very
valuable in overcoming the inner forces leading a person to contemplate
taking his own life. When it comes to the "inevitable case" that still insists
upon suicide, the question arises whether we should overcome our present
mores
to permit such a person to end his own life in a dignified way which would
permit utilization of his organs. . . . One would think that the stigma that the
friends and relatives attach to a suicide would be much lessened if they knew
several persons would live as a result.123
The issue of "positive euthanasia" which is raised in an oblique fashion
by this suggestion was confronted directly a number of years ago by one
of our consultants, Dr. Belding H. Scribner, in his presidential address to
the American Society of Artificial Internal Organs: w
[l]f I knew that I had a fatal disease I would seriously consider volunteer-
ing to donate one of my kidneys while \ was still well. As far as death is
concerned, I would like to be able to put into my will a paragraph urging
that when my physician felt that the end was near, I be put to sleep and any
useful organs taken prior to death. ... I think that ethical and legal guide-
lines should be devised to permit me and others to volunteer in these ways.124
At the present time a number of groups and individuals are drafting statutes
on euthanasia and urging their enactment.125 Although we doubt that such
measures would meet with widespread approval today, and we have not
seen any which avoid the conflict-of-interest problem without an impos-
sibly cumbersome judicial mechanism, we think it is appropriate for persons
working in the catastrophic disease area to show the effect which euthanasia
could have on the treatment of disease.
122 Blachly, Can Organ Transplantation Provide an Altruistic-Expiatory Alterna-
tive to .Suicide!, 1 Life-Threatening Behavior 6 (1971).
123 Id. at 9. We would reject this specific proposal because it can easily lead to
exploitation of the therapeutic relationship.
124 Scribner, Ethical Problems of Using Artificial Organs to Sustain Human Life,
10 Trans. Am. Soc. Art. Organs 209, 211 (1964).
12SThe primary concern of the euthanasia proponents is not, of course, organ
transplants but the pain and expense involved in the prolonged cart of terminal,
debilitated and often unconscious patients.
317
ATTACHMENT E
Excerpts from
Catastrophic Diseases:
Who Decides What?
A Psychosocial and Legal A nalysis
of the Problems Posed by Hemodialysis
and Organ Transplantation
Jay Katz and Alexander Morgan Capron
Russell Sage Foundation New York
1975
23-029 0-83-21
318
Stages of Decisionmaking
Present organ-sharing arrangements are informal and nonbind.ng. Once
the kidneys are obtained, how they are distributed is currently a matter
mostly of who salvaged the kidneys."" Although it is true under the Uni-
form Anatomical Gift Act that physicians act as "recipients of cadaver
organs it is clear that the intent of the Act was that they were only trustees
and that they need be given no personal control ovei who receives the
organs Therefore, there should be no legal impediments to moving beyond
the present informal systems, such as that operated out of UCLA. More
than 500 organs have already been shared among more than 90 transplant
centers through the UCLA tissue-matching and recipient registry but the
nonmandatory nature of the system creates problems of its own. Less than
the best matches occur for two reasons. First, part.c.pat.ng transplant
centers typically share only one kidney from the cadaver and keep the
other for one of "their own" patients. Second, a center winch has shared a
kidney gets a "credit" which places it in a preferential position for receiv-
ing future kidneys from other centers.
The emphasis on the "ownership" of the donated kidney thus biases the
choice of the recipients according to the center at which they are await.ng
treatment rather than solely according to the medical probabilities (e.g.,
closeness of tissue type, surgical success record of physician Performing
the operation, etc.). As techniques of organ preservation and tissue match-
ing are perfected, there is no excuse for a continuation of a system which
relies on arbitrary, nonmedical factors in the assignment of scarce resources
such as cadaver organs.23 If a transplant center wishes to participate in a
national organ-sharing arrangement, in order to increase the range : of : ussue
types it can offer to patients, it should be obliged to share all the cadave
organs which become available to it. We are not persuaded of the danger
that physicians' motivation to seek cadaver organs will be destroyed rf the
organs are going to be shared with the best-matched patients at otbe
hospitals. The greater supply of, and better chances with, such organs wil
provide sufficient motivation for physicians, who-like potential donors
and their families-will be made more aware of organ donation as a con-
22Tcrasaki, Organ Transplantation (consultant's memorandum), at 3 (1972) [Ap-
pendix K]. The informal system of organ sharing has nevertheless been "markably
Successful, although a much greater degree of organization »"< «£Pe»l,on Trf M
needed to produce an adequate supply of cadaver kidneys. By 1 972 nearly half of. 11
cadaver kiLys transplanted were obtained from other hosp.ta Is (600 shared I w.thm
the same city and 455 shared between cities). A wide, nal.on.l pool o f donos nd
recipients is particularly necessary.to avoid mismatches caused by ^^^
See Opelz 4 Terasaki, National Utilization of Cadaver Kidneys for Transplantation,
2V£eMrL™ wltL * McClelland. National Transplant Communicanons
Network, 218 J.A.M.A. 1674-78 (1971).
319
Administration of Major Medical Interventions 237
tribution to an important national need with the potential of saving many
lives.
2. Research v. Therapy
An example of a national administrative decision of a very different type
would be the need to decide when an intervention designated as "research,"
in the sense discussed in Chapter Eight, has become "therapeutic." Al-
though basic policies on this and similar matters will have been established
previously at the formulation stage, these policies are not self-executing.
Thus, national bodies must keep abreast of the progress of catastrophic
disease research and treatment in order to determine, inter alia, when a pro-
cedure which had been available only on a limited "research" basis should
be more widely offered or whether a procedure which had called for review
by the local Institutional Advisory Committees should be regarded as no
longer needing protocol approval.
320
ATTACHMENT F
Excerpts from
Summing Up
Final Report on Studies
of the Ethical and Legal
Problems in Medicine
and Biomedical and
Behavioral Research
March 1983
President's Commission for the Study of
Ethical Problems in Medicine and
Biomedical and Behavioral Research
321
72 Summing Up: Chapter 4
*
if *
Limited Resources. As has already been noted, the princi-
ples of serving well-being and promoting self-determination
sometimes point in conflicting directions. Yet in the normal
course of treatment and research, pursuing them in tandem
tends toward the achievement of people's health as they define
it. The capabilities of the biomedical sciences both to prevent
and to cure illness have expanded immensely in the past half-
century; today, health care can offer dramatic remedies for
previously untreatable conditions. Nonetheless, an important
factor confounds the pursuit of the goal of good health to the
full extent indicated by the well-being and self-determination
principles: the inescapable reality of limited resources. As the
capabilities of health care have expanded, the strain placed on
already strapped personal budgets, employer-provided health
benefit programs, and the treasuries of governments at all
levels — from local to Federal — has become a matter of increas-
ing concern.
The reality of restricted resources means patients, health
care professionals and institutions, and society at large must
face an ethical problem: having to choose the uses to which
limited — in some cases, very scarce — resources will be put.
The choices require comparing health care expenditures with
other areas of public and private spending, as well as with
choices within the health care budget — between treatment and
research; between restorative steps for those already ill and
preventive steps for those who may be at risk; among different
age-groups, diseases, treatment settings, and so forth.
The ethical dilemmas created by the competition for
limited resources were vividly displayed in the late 1960s by
the efforts to save the lives of patients with kidney failure. Two
treatments were available. First, if a donor could be found, a
patient's diseased kidneys could be replaced by a healthy
kidney. Transplantation offered a "cure" when it was success-
ful, but the supply of kidneys was inadequate and even when
322
Recurrent Themes 73
transplantation occurred in most caBes it did not succeed
because of organ rejection, infection, or the failure of the new
kidney for some other reason. Alternatively, patients could
undergo hemodialysis two or three times a week, during which
their blood was run through a machine for six to eight hours to
cleanse it of impurities. While improvements were constantly
being sought in both forms of treatment, dialysis was regarded
as a proven and reliable (albeit arduous and expensive)
method for saving the lives of people who were often otherwise
healthy and who, if treated, could look forward to an indefinite
continuation of a nearly "normal" life.
Since there were many more people with end-stage renal
disease than the dialysis facilities could accommodate, various
methods were adopted to select the patients who would be
treated. The tragedy of the situation received extensive
coverage in the media, including articles about groups like the
"God Committee" in Seattle, ordinary citizens who had to
decide who in their community most deserved this life-saving
resource. At other hospitals, dialysis was allocated on a first-
come-first-served basis or according to patients' ability to pay.9
By the early 1970s — as the number of people treated
moved beyond the small percentage it had been during the
early, experimental stages to a greater (though still fractional)
portion of the total need — the contrasting fates of those treated
and the larger number who died untreated — became intolera-
ble. Rather than continue to seek methods of allocating the
resource fairly, a decision was made to make it available to
every American with end-stage renal disease under a special
provision in the Medicare program.
This response to the dilemma of limited resources is
understandable. Indeed, it may have been inevitable, given the
drama of identifiable patients who died because they could not
obtain life-saving medical treatment. Moreover, the cost of
overcoming the tragedy seemed acceptable — in part because of
the way in which the number of "eligible" patients was
estimated. Over the past decade, however, expenditures on the
End Stage Renal Dialysis Program (now totaling approximately
$2 billion per year) have exceeded the original estimates
manyfold and the standards for eligibility for dialysis, no
longer constrained by a scarcity of resources, have expanded
to include many patients whose age or concurrent diseases
would have left them out of the calculations of the relevant
"pool" of patients in 1972."
• Jay Katz and A. M. Capron, Catastrophic Diseases: Who Decides
What?. Russell Sage Foundation. New York (1975) at 184-96.
10 This serves as another reminder of the interaction of "facts" and
"values" — in this case, the understandable (and probably uncon-
scious) tendency of physicians to exclude from eligibility for dialysis
those patients whose characteristics made their prognosis least
323
74 Summing Up: Chapter 4
Dramatic, "big ticket" treatments like kidney dialysis and
transplantation — or the implantation of an artificial heart at
the University of Utah Medical Center in late 1982 — are not yet
the major strains on the health care budget, but they do
crystallize the ethical issues posed by limitations on society's
resources. The Commission concluded that these issues cannot
be avoided by the sort of response — "give everyone all they
need" — that was used for kidney failure. Instead, the Commis-
sion turned to the ethical principle of equity. This principle is
always a hard one to know how to apply — as can be seen in
the role it played in several Commission reports.
It received greatest attention in the report on the ethical
and legal implications of differences in people's access to
health care. On the one hand, the Commission concluded that
the importance of health care — in promoting well-being, pre-
venting death and disability, relieving pain, restoring function-
ing, and generally ensuring opportunity — and the uneven and
largely undeserved incidence of illness generated an ethical
obligation of society in this area that does not necessarily exist
regarding other things. Yet the principle of equity does not
create a "right" to health care equal to all the care that some
people may obtain for themselves, nor even all that people may
want or need, in the sense of its being of some benefit. Rather,
equity requires that people have access to an adequate level of
care and that the costs of care be fairly distributed. As is
always the case in dealing with general principles, such as
equity, many of the hardest questions — such as "what level of
care is adequate?" and "what constitutes fair distribution?" —
remain to be resolved in the context of particular decisions.
Instead of searching for a definitive interpretation of the
concepts, the Commission attempted to set forth terms of
reference by which those who are responsible for formulating
policy on health care could compare the ethical implications of
alternative proposals.
favorable. Unlike choices between patients based on such social
factors as wealth, education, marital and parental status, and the like,
the criteria of "medical suitability" were regarded as "objective."
With sufficient resources, it proved possible to redefine "suitability"
since the patients with less favorable prognoses were no longer
competing with those who "deserved" the treatment more because
their prognoses were better. Though few would argue with a decision
to use scarce resources for those most likely to benefit from them, any
decision based on people's deserts is plainly one that involves values,
not merely objective facts.
324
ATTACHMENT G
Excerpts from
Securing
Access to
HealthCare
A Report on the
Ethical Implications of
Differences in the
Availability of
Health Services
Volume One: Report
March 1983
President's Commission for the Study of
Ethical Problems in Medicine and
Biomedical and Behavioral Research
325
An Ethical Framework 35
4-
jl -a
Meeting the Societal Obligation
How Much Care is Enough? Before the concept of an
adequate level of care can be used as a tool to evaluate
patterns of access and efforts to improve equity, it must be
fleshed out. Since there is no objective formula for doing this,
reasonable people can disagree about whether particular
patterns and policies meet the demands of adequacy. The
Commission does not attempt to spell out in detail what
adequate care should include. Rather it frames the terms in
which those who discuss or critique health care issues can
consider ethics as well as economics, medical science, and
other dimensions.
Characteristics of adequacy. First, the Commission con-
siders it clear that health care can only be judged adequate in
relation to an individual's health condition. To begin with a list
of techniques or procedures, for example, is not sensible: A CT
scan for an accident victim with a serious head injury might be
the best way to make a diagnosis essential for the appropriate
treatment of that patient; a CT scan for a person with
headaches might not be considered essential for adequate
care. To focus only on the technique, therefore, rather than on
the individual's health and the impact the procedure will have
on that individual's welfare and opportunity, would lead to
inappropriate policy.
Disagreement will arise about whether the care of some
health conditions falls within the demands of adequacy. Most
people will agree, however, that some conditions should not be
326
36 Securing Access to Health Care: Chapter 1
included in the,societal obligation to ensure access to adequate
care. A relatively uncontroversial example would be changing
the shape of a functioning, normal nose or retarding the normal
effects of aging (through cosmetic surgery). By the same token,
there are some conditions, such as pregnancy, for which care
would be regarded as an important component of adequacy Ln
determining adequacy, it is important to consider how people s
welfare, opportunities, and requirements for information and
interpersonal caring are affected by their health condition.
Any assessment of adequacy must consider also the types
amounts, and quality of care necessary to respond to each
health condition. It is important to emphasize that these
questions are implicitly comparative: the standard of adequacy
for a condition must reflect the fact that resources used for it
will not be available to respond to other condit,ons. Conse-
quently, the level of care deemed adequate should reflect a
reasoned judgment not only about the impact of the condition
on the welfare and opportunity of the individual but also about
the efficacy and the cost of the care itself in relation to otfier
conditions and the efficacy and cost of the care that is
available for them. Since individual cases diff er so much Ihe
health care professional and patient must be flexible. Thus
adequacy, even in relation to a particular health condition,
generally refers to a range of options.
The relationship of costs and benefits. The level of care
that is available will be determined by the level of resources
devoted to producing it. Such allocation should reflect the
benefits and costs of the care provided. It should be empha-
sized that these •'benefits." as well as their "costs should be
interpreted broadly, and not restricted only to effects easily
quantifiable in monetary terms. Personal benefits include
improvements in individuals' functioning and in their quality of
life and the reassurance from worry and the provision of
information that are a product of health care. Broader social
benefits should be included as well, such as strengthening the
sense of community and the belief that no one in serious need
of health care will be left without it. Similarly, costs are not
merely the funds spent for a treatment but include other less
tangible and quantifiable adverse consequences, such as
diverting funds away from other socially desirable endeavors
including education, welfare, and other social services.
There is no objectively correct value that these various
costs and benefits have or that can be discovered by the tools
of 'cost/benefit analysis. Still, such an analysis, as a recent
report of the Office of Technology Assessment noted can be
very helpful to decisionmakers because the process of analysis
gives structure to the problem, allows an open consideration of
327
An Ethical Framework 37
all relevant effects of a decision, and forces the explicit
treatment of key assumptions."27 But the valuation of the
various effects of alternative treatments for different condi-
tions rests on people's values and goals, about which individu-
als will reasonably disagree. In a democracy, the appropriate
values to be assigned to the consequences of policies must
ultimately be determined by people expressing their values
through social and political processes as well as in the
marketplace.
Approximating adequacy. The intention of the Commis-
sion is to provide a frame of reference for policymakers, not to
resolve these complex questions. Nevertheless, it is possible to
raise some of the specific issues that should be considered in
determining what constitutes adequate care. It is important, for
example, to gather accurate information about and compare
the costs and effects, both favorable and unfavorable, of
various treatment or management options. The options that
better serve the goals that make health care of special
importance should be assigned a higher value. As already
noted, the assessment of costs must take two factors into
account: the cost of a proposed option in relation to alternative
forms of care that would achieve the same goal of enhancing
the welfare and opportunities of the patient, and the cost of
each proposed option in terms of foregone opportunities to
apply the same resources to social goals other than that of
ensuring equitable access.
Furthermore, a reasonable specification of adequate care
must reflect an assessment of the relative importance of many
different characteristics of a given form of care for a particular
condition. Sometimes the problem is posed as: What amounts
of care and what quality of care? Such a formulation reduces a
complex problem to only two dimensions, implying that all
care can readily be ranked as better or worse. Because two
alternative forms of care may vary along a number of
dimensions, there may be no consensus among reasonable and
informed individuals about which form is of higher overall
quality. It is worth bearing in mind that adequacy does not
mean the highest possible level of quality or strictly equal
quality any more than it requires equal amounts of care; of
course, adequacy does require that everyone receive care that
meets standards of sound medical practice.
Any combination of arrangements for achieving adequacy
will presumably include some health care delivery settings that
mainly serve certain groups, such as the poor or those covered
by public programs. The fact that patients receive care in
different settings or from different providers does not itself
v Office of Technology Assessment, U.S. Congress, The Implications
of Cost-Effectiveness Analysis of Medical Technology, Summary.
U.S. Government Printing Office. Washington (1980) at 8.
328
38 Securing Access to Health Care: Chapter 1
show that some are receiving inadequate care. The Commis-
sion believes that there is no moral objection to such a system
so long as all receive care that is adequate in amount and
quality and all patients are treated with concern and respect.
At this point, the complexity of the problem of deciding
what constitutes adequate care is apparent. However, clear
and useful conclusions can emerge even when there is no
agreement on the details of adequacy. In the case of pregnant
women, for example, there is a consensus in the United States
that some prenatal care, the attention of a trained health
professional during labor and delivery, and some continuity
between the two are all essential for an adequate level of care.
A stronger consensus is required if proposals for change
are fo be evaluated. Some of the processes that may be used to
develop a societal consensus on adequacy are already a
familiar feature of the health care system, and do in fact play a
329
An Ethical Framework 39
role in determining the amount of care that is provided,
especially to beneficiaries of public programs.28
Professional judgment. Physicians and other professionals
who provide health care are familiar with human needs for
care, so that the first means that might be employed in defining
an adequate level of health care would be a reliance on
individual health care practitioners' judgment of the "medical
necessity" of any particular service. However, sole reliance on
professional judgment in setting limits is not appropriate
because of professionals' tendency to provide all possible
medically beneficial care. At the very least, the extent and
manner in which professionals exercise judgment to limit the
use of care that is of little benefit (relative to cost] varies
widely. Thus, without substantial changes in individual health
care professionals' present practices, this method of defining
adequate health care is likely to result in an uncertain and
overly inclusive definition.
Another way that professional judgment might be used to
define adequacy is to rely on the standards of medical practice
as adopted by the professonal community through, for exam-
ple, consensus conferences. The advantage of such an ap-
proach is the specialized knowledge of the effects of care that
such people have. However, there are also serious disadvan-
tages.
Professionals have no special expertise in deciding how
the effects of medical care ought to be valued, either with
respect to the relative value of different dimensions of care or,
particularly, the value attached to health care relative to other
goods. In the last two or three decades, for example, there have
been major changes in prenatal and obstetrical care, in many
cases in response to the preferences of parents: changes in the
use of anesthesia; the kind of contact possible between mother,
father, and infant in the hospital; the information provided to
the family about the birth process; support for breast-feeding
as opposed to formula-feeding. These changes were never
shown to be harmful or uniformly beneficial, but rather
represent differences in the valuing of benefits.29
Professionals often have no special knowledge of the costs
of different alternatives and perhaps little appreciation of the
other goods foregone for the sake of health care. Studies show
** For a discussion of determinations of the amount and type of care
under public programs. Bee Chapter Three infra, although the pro-
cesses now used would not necessarily have the same role in the
determinations of adequacy recommended here.
" (n many cases there is now a medical consensus that the new
practices are in fact superior. Nevertheless, strong pressure from
consumer* was required to bring some of them about
330
40 Securing Access to Health_Care: Chapter 1
that practitioners are frequently unaware of the financial costs
of many of the tests and procedures that they order."
Finally, their involvement with the delivery of care may
sometimes'create a barrier to full , =on.,dera ion of a 1 o£ ion,
Manv observers have noted a bias in health care in ims
cluntrytwaTd the introduction of expensive high-technology-
based procedures delivered by existing institutions -n^n.
the introduction of alternative ways to provide services at
lower cost."
Because of these factors, professional judgment cannot
«;tand alone as the determinant of adequate care, but the
pTc^d knowledge of health care Profesf nal. abou the
effects of health care is essential as part of any process ot
determining adequacy.
^^^^cujrenU^ The United States at present has a
sophlSSeTl^aTtr^e system and there is reason to
uppose that the average American obtains an adeq-ate toUd
amount of care. Defining adequacy in ^^f.^^ of
nresentlv enjoyed by the average person has the advantage o
?ea ism it reflects the outcome of the health care system as it
now operates-what actually happens as a result of patient-
res dents a„d even medical faculty are equally uninformed about the
or ces of the tests and treatments they order." Anthony L. Komaroff.
The Doctor the Hospital and the Definition of Proper Medical
Practice (1981). Appendix U. in Volume Three of this Report a
Education Tin sectfon five. Komaroff cites a number of »n.d.e. a.
Samples S P. Kelly. Physicians' Knowledge of Hospital Costs. I
FXAXc 171 (1978); S.J Dresnick et ah, The Physician's Role in the
Cast^nlinJent Problem. 241 J.A.MA 1606 ^^^tV*
al Medical Students' Unfamiliarity with the Cost of Diagnostic Tes^
50 J Med. Educ 683 (1975); L.R. Kirkland. The Physician and Cast
Containment, 242 J.A.M.A. 1032 (1979). following
« Dean David Mechanic of Rutgers University gives the following
example of this:
One of the most prevalent conditions among children is sore
Croats, and it is routine to take a throat culture before
u^eatment to assess whether the cause is a streptococcal
Section. Typically, the mother is required to bnng the child to
a pediatrician forthe culture, often involving inco„ve„.ence
and considerable expense. As an experiment at the Cohimb a
Medical Plan has demonstrated, mothers can be effectively
taSructed to take a throat culture at home, negating the need
o Vhysician and nurse care in most instances and -creasing
the convenience and satisfaction of the mother The bam J
individual responsibility built in to medical care must be
' reviewed carefully, and efforts should be made to modify them.
David Mechanic. Future Issues in Heal™ Care: Social Policy ^ and
the Rationing of Medical Services. The Free Press. New York (1979)
at 37 (citation omitted).
331
An Ethical Framework 41
provider interaction, not merely what planners believe ought to
happen.
Nevertheless, there are good reasons to pause before
adopting "current use" as the benchmark of adequacy. Many
distortions in people's true preferences for health care affect
the average level of care received — for example, those whose
access is now unduly limited bring down the average, while
those who overspend for health care because of insurance and
tax advantages (discussed in Chapter Three) inflate the
average. Also, structural characteristics of the delivery system
can mean that even people with good access do not necessarily
receive an appropriate mix of services.
A possible variation of the concept of average use is to
adopt as a point of reference the care received by people of
average financial means who live in areas that are sufficiently
provided with health care resources. This approach could
incorporate a broader dimension of preferences, including an
explicit consideration of the value of care relative to its cost.
Unlike most approximations of adequacy this concept is more
amenable to measurement. In fact, a modification of average
use — people with similar health conditions receiving the same
volume of care at a standard acceptable to middle-class
Americans — is now employed by the Robert Wood Johnson
Foundation in determining when adequacy is achieved.52
Unfortunately, this approach also has its weaknesses.
Again, in making choices about health care, patients may
inappropriately evaluate those costs that are covered by
insurance. Moreover, recognizing their lack of knowledge,
patients generally rely heavily on their practitioner's judgment,
which as noted earlier may favor care that is disproportionate-
ly costly relative to its benefits. On the other hand, if a patient
makes an independent choice it may be an uninformed one
that rejects care that is actually of significant benefit relative
to its cost. Thus, people of average means may lack some care
that ought to be part of an adequate level while they receive
some care that ought not to be included in it.
Nevertheless, this concept also has a role to play in
determining adequacy. In particular, if some of the distorting
factors could be lessened, the care sought by well-educated
people of average means might be a reasonable benchmark, at
least for the treatment of serious conditions.
List of services. Another alternative is to attempt to
specify a list of services to be included within an adequate
level of health care. An example is the list of "basic health
services" in the Health Maintenance Organization (HMO) Act
of 1973 (as amended), which includes physician services,
12 Testimony of Robert J. Blendon, transcript of 24th meeting of the
President's Commission (SepL 10, 1982) at 21.
332
42 Securing Access to Health Care: Chapter 1
inpatient and outpatient hospital services emergency health
se™ ces. short-term outpatient mental health services up to 20
visTtsl reatment and referral for drug and alcohol abuse,
laboratory work and X-rays, home health services, and certain
preventive health services."
The broad categories on this list might be broken down
into more specific se'rvices. However, such . list of *™
no more a specification of an adequate level of care than a hat
of foods is an adequate diet. What makes the HMO list in to an
"adequate level" specification is its combination with a
delivery mechanismPthat relies on professional judgment to
determine the appropriate amounts of services on t . «.e-b£
raqp basis with organizational and financial incentives to
weTgh^ie benefits of services against cost. Other approxima-
tions in this same spirit include insurance contracts that
Incorporate reviews of the appropriateness of services re-
ceived.
Overall evaluation. It would, of course, be possible to
combine several "a^pToaches- by specifying categories of
L'ices that mUst ^available as part of adequate care, for
Sample, while placing limits on the overall use of s™
through a health insurance package valued at a specified
amount. Another variation of this approach would involve an
effort by the medical profession to redefine standards of
practice to incorporate some assessments of the costs and
benefits of acceptable alternative therapies. This might be
achieved through medical education, consensu, wntonce.
and other methods. Such determinations would of course take
place within a process that allowed an interplay between the
heaWi^re professions and political and other social factors.
The Commission cites these alternatives as examples of
possible initial approaches to approximating an adequate level
of health care that should be available to all Americans. There
are both theoretical and practical differences between these
approaches, yet each has something to offer, separately and
Together. For the purpose of health policy formulation, general
Stories as well as ordinary views of equity do not determine a
unique solution to defining adequate care but rather set some
o?oad limits within which that definition should fall. is
reasonable for a society to turn to fair democratic political
procedures to make a choice among just alt eniatives. Gn enfce
£reat imprecision in the notion of adequate health care
however, it is especially important that the procedures used to
define that level be— and be perceived to be— fair.
l^aHhMaintenance Organization Act ofT973 [Pub. L. No. 93-222).
333
Mr. Gore. Professor Capron, that is entirely appropriate.
We appreciate the approach you take to these issues. You have
helped us on a number of occasions to understand these matters a
lot better.
How do you react from a bioethical perspective to the fact that
Mr. and Mrs. Fiske were unable to get their child, Jamie, listed as
a potential liver recipient until they could assure that the insur-
ance company would pay for the transplant? She was going to die
if she didn't get it. They couldn't even get her on the list.
The hospital didn't present it that starkly. I thought his testimo-
ny was quite good on that point. They won't present it quite that
starkly, but in fact that is what happens. That is exactly what hap-
pens.
Captain Broderick yesterday came here with his daughter, who is
going to die unless she gets a transplant, and the CHAMPUS pro-
gram, the Government health care program that takes care of
active duty military people and their families, refuses to pay.
Is it unethical for us as a society to say to the parents of these
children and to the children themselves, that they have to die be-
cause we think the operation is too expensive?
Mr. Capron. I think the question is not simply whether it is too
expensive. As a human being, I react with compassion and with
concern for those people. If I were a physician and being asked to
perform a treatment for free, or a hospital administrator and being
asked to absorb those costs and pass them on to other people, in
effect, that would be a difficult question for me to answer. I believe
I would like to say that I would try to help that particular person.
But what we are talking about here in the Commission's view is
a standard for making some form of public policy which has to be
based on something other than an individualized, compassionate re-
action to an individual situation. We need a number of mecha-
nisms through which to judge whether liver transplantation is part
of that adequate level of care that society is obligated to insure is
provided to everyone?
To do that, there are a number of mechanisms. One is the mech-
anism which I believe the CHAMPUS program has cited, which is
to say is this a procedure which is regarded by physicians as now of
proven benefit. Even if someone says I have a technique that might
save someone's life, we wouldn't necessarily run to pay for that as
part of established medical care until it has some proven benefit.
That is not the end of the discussion, in the Commission's view.
That is only one way in which adequacy can be determined. An-
other is to look at what people would regard as the sort of care
they would expect to receive if they were paying for insurance
themselves. One of the things about our present insurance system,
of course, is that it tends to subsidize the purchase of health insur-
ance so that people have health insurance plans that are much
more generous than they would have if they were really comparing
health care with other things.
After all, we aren't just talking about medical care to save life.
We are talking about the expenditure of our resources on all the
aspects of life. So, that is another means of measuring. Already,
with some of the changes that have been made in the tax law in
the last Congress, we are moving in that direction, of recognizing
334
that subsidized health care through employer, subsidies and so
forth may tend to be written at a higher level and lead to extrava-
gance.
Another thing is to compare this particular condition that you
are talking about treating, its effect on opportunity and on life,
with other conditions and ask how we respond there as a society.
With the precedent established by end-stage renal disease in
1973, the situation really changed. We now have at least one prece-
dent which says that when we have a disease that can be treated
in this way, with roughly this sort of expenditure of funds, we be-
lieve in making the social resources available. In effect, as a society
we are defining that as part of an adequate level. I think that is a
decision we have to examine and ask how far we press that.
As I said, we already find physicians having to make choices.
The example the Commission gave is that it would not seem justi-
fied, although the funding is literally there, to use the resources to
treat a patient who goes into kidney failure who is in a permanent
state of unconsciousness, because the benefit to the patient would
be so small.
So, I believe one has to compare, in talking about whether soci-
ety has an obligation, the relative benefit of this procedure versus
other procedures. It is a matter of beginning with those things
about which we have greatest agreement and working outward
from there. Liver transplantation now is somewhere on the fringe,
not close to the core agreement that we have, but something that
we build out from our core agreement.
Mr. Gore. Professor Capron, I get the feeling that maybe there is
some sensitivity on the part of the Commission after the reaction
to your report on the obligation of society to provide care. At least
I hear a great deal of caution in your response.
Mr. Capron. I don't mean to be cautious so much as saying that
this is not a subject to which I think a simple answer can be given.
Mr. Gore. Let me change the question slightly. If one accepts as
fact the testimony of the leading experts in the world, who testified
here yesterday, that there is now a 75 percent success rate with
this procedure, and if you further accept as the fact the assertion
that in many, if not most, of these cases the cost of providing for
care up to and until death will exceed the cost of the transplant
intervention, which saves that person's life, then is it unethical for
us to tell the families of these children that they can't have the
operation because society can't afford the up-front cost of the trans-
plant.
Mr. Capron. I don't think that this is a forum in which that deci-
sion can be made. I can give you my response to it, which is if you
are saying that you are already agreeing and obligated to pay so
many hundreds of thousands of dollars for care which is merely, in
effect, custodial care for a person as they die and isn't providing
them any cure, it would seem, just from the viewpoint of saving
the money, that it is not a matter of ethics, it is a matter of
common sense to say one would prefer to spend the money to give
the person a 75-percent chance of then living a normal life.
The problems with reaching a generalization from that is that
that is not the case with a lot of the sorts of conditions we are talk-
ing about. That, in a way, is a convenient peg to hang that particu-
335^
lar example on. Unfortunately, a lot of the examples are not going
to fit that way.
A person who is in end-stage renal disease may die quite rapidly.
If we didn't have the present program, I think it would be very
hard to make that argument. At the time that Dr. Barney Clark
died, at his funeral, Wilhelm Kolff, who was the inventor of the ar-
tificial kidney and a primary inventor of the present mechanically
implanted "Jarvik heart" that was used for Dr. Clark stated, in his
view, "We are now ready to give relief to the tens of thousands of
victims of heart failure in this country." There will be people who
believe that now and who will say since Barney Clark lived for 5 or
6 months, that is a success. Are we prepared now to make that de-
termination for the artificial heart?
I think we have to look at all the facts of a case. In many of
those cases we will not have the more convenient out of saying
look, it is just good, prudent economics to spend the money to try
to give a cure rather than to spend the money to just watch some-
one die.
Mr. Gore. We will pursue that with our other witnesses, but it
seems to me a related issue is how quickly the system responds
with updated bioethical judgments to new and different facts, such
as a dramatically improved success rate and the new figures on the
economics of the procedures involved.
Mr. Capron. One ability that the system had prior to 1981 to re-
spond was the National Center for Health Care Technology, which
was established in 1978 and had 3 years of life. It was beginning to
give exactly that kind of more sophisticated advice to the Health
Care Financing Administration and then was eliminated. There
are means by which people can give advice of the sort that you are
saying so that the system does respond.
Mr. Gore. Let me try one more time. Let me ask the question a
little different way. Let's try it one more time and then we will let
you go and go to the other witnesses.
Leaving the fact that you can probably save money out of it, here
you have got a child. This child is going to die within two months.
Her parents don't have the money to pay for the operation. If she
gets the operation, she will almost certainly live a normal, healthy,
productive life.
We as a country look at that set of circumstances. If we say to
the parents of that child, your child must die because we don't feel
any obligation to help you finance the operation that will save her
life.
In your opinion, if society made that decision, would it be justi-
fied in doing so? Let me ask the question a little bit differently.
You are telling me, in your responses, that the answer is now
clear. You don't think the answer is clearly yes, we have an obliga-
tion to save that child's life in those circumstances?
Mr. Capron. That is correct. The situation I think is different
from the personal obligation because when we make societal judg-
ments like this we establish a statement about our obligations not
just toward that one child, but toward many people in the situa-
tion. Is the fact that it is a child important in your example, for
example? What about a 50-year-old person. What is the difference?
It is a human life.
336
Mr. Gore. I am not sure I can define a legalistic distinction. It
makes it easier for me to understand it. Maybe that is wrong on
my part.
Mr. Capron. Whenever you have an example, you have a child
who has fallen into a well or a miner trapped in a mine, we will
spend tens or hundreds of thousands of dollars to try to get the per-
sons out of the predicament on the possibility that they are alive.
People will risk their lives to get that identifiable person.
Of course, when you have a Jamie Fiske or any other identifiable
child and the basic statement is that what stands between that
child and a chance at life is money, we want to say spend the
money. It is small potatoes to the things that are on the walls of
this conference room. We spend all that money shooting things up
into space, and we are talking about saving a human life.
If it were my decision, sir, my answer would be save that life.
But I recognize that we are not just talking about that one child.
We are talking about a statistical problem. The fact of the matter
is, although we have that compassion, we haven't done a lot yet to
make the organs available that are necessary. Why should we be
talking about money? Here is something which we can give with-
out cost. I don't know how many people in this room have organ
cards. How many people have taken that step?
If we're talking solely about the money, it may well be that the
liver transplant situation is the kind of situation where we ought
to include that now. We ought to say CHAMPUS, medicare, medic-
aid and Blue Cross, to the extent that we influence the private pro-
grams and so on, yes, they ought to pay. It has established value
and it is life-saving and so forth.
I am just saying it is not simply a question of money. We still
end up with hard choices as to the indications in any particular
case. Moreover, there are other things that society could do. I
would like to see us not forget about those as well.
Mr. Gore. Thank you very much, Professor Capron. I have too
much respect for your judgment not to pause at the fact that I dis-
agree with you slightly on this.
Mr. Capron. Why don't you come to my class and we will talk
about it there? Then I am sure you will agree with me.
Mr. Gore. Thanks anyway.
Dr. Veatch and Dr. Childress, thank you for your indulgence. We
will continue the panel with you, Dr. Veatch, the professor of medi-
cal ethics and senior research scholar at the Kennedy Institute of
Ethics at Georgetown University.
Thank you for your patience and for your willingness to contrib-
ute to this hearing.
Mr. Veatch. Thank you very much.
I have been asked to review bioethical and religious issues sur-
rounding organ procurement. I am a Methodist, but I want to
make clear that I am speaking for no religious or academic group
and shall try to present as fairly as possible my understanding of
the views of the major groups on the issues at hand.
Furthermore, in the interest of time, I want to limit my remarks
to procurement of cadaver organs and I want to summarize at least
some of the points that are developed more fully in written testi-
mony.
337
As I understand the contemporary bioethical debate over organ
procurement, it contains two issues that I will label as preliminary
and two that are more central. The ethics of the definition of death
and the ethics of removal of cadaver organs I take to be prelimi-
nary, while the donation versus salvaging controversy and the
ethics of fairness in organ distribution I take to be central.
All of the major religious groups reveal some differences of opin-
ion over the shift to the use of brain-oriented criteria for the defini-
tion of death. I summarize those in my written testimony. I will
skip over them.
Jumping to my summary, at least some responsible members of
all of the major religious traditions accept the brain-oriented defi-
nition theologically and find it appropriate as a basis for procuring
cadaver organs, at least for lifesaving interventions.
There is also substantial ethical agreement on what I described
as the second preliminary ethical question, the ethics of the remov-
al of cadaver organs. There has been in general no objection among
either the religious or the secular bioethical community to the re-
moval of organs for lifesaving purposes, although there are objec-
tions of removing them for other purposes, once it has been estab-
lished that the patient is indeed dead.
I would like to focus my attention on what I described as the two
more critical or central ethical issues.
First, the controversy over donation versus salvaging of organs.
It has been recognized for several years that there are really two
basic alternatives for organ procurement: donation and salvaging.
It is the second alternative that is favored by virtually every
writer within the Judeo-Christian tradition and by every religious
group speaking on the subject. The reason is that according to the
Judeo-Christian tradition, our respect for the individual and the
rights associated with the individual do not cease with death.
In the Judeo-Christian tradition, as opposed, for example, to
much Greek thought, the body is affirmed to be a central part of
the total spiritual being. Any scheme that abandons the mode of
donation in favor of viewing the cadaver as a social resource to be
mined for worthwhile social purposes will directly violate the cen-
tral tenets of Christian thought and create serious problems for
Jewish thought as well, at least when Jews are not in a State gov-
erned by Jewish law.
At the same time, there is uniform support in all the major reli-
gious traditions, not only for the ethical acceptability of donations,
but the actual moral obligation to take organ donation seriously.
This suggests that while all traditions would oppose routine sal-
vaging, the kind of scheme Alex Capron was talking about of just
taking the organs, these traditions would look favorably upon
public policies to make donation as easy as possible.
The public policy implication is that the correct solution to the
donation versus salvaging controversy is maximum encouragement
to facilitate donation, provided that this does not subtly coerce
those unwilling to donate or trick them into donating without real-
izing it.
The schemes to indicate willingness to donate on State driver's
licenses, for example, seem very reasonable. In addition, I would
338
endorse all of the schemes that were proposed earlier, Dr. Ogden's
scheme, making this part of routine admission to a hospital.
I would also suggest that we look at the possibility of incorporat-
ing organ donation into Federal documents, especially those al-
ready computerized for easy retrieval, such as income tax or social
security records. This provides, in addition, an opportunity for reg-
ular updating of the individual's wishes.
The ideal form of the question about willingness to donate would
permit three responses, yes, no, and no response, thus not creating
any presumptions or pressures. This strategy seems far preferable
to continental European public policies authorizing routine salvag-
ing unless objection has been registered.
It is even preferable to a British scheme, endorsed by the British
Working Party of the Health Department in Britain, which would
give a designated government or hospital official the power to
remove organs for transplant in cases where no objection has been
registered and relatives cannot be located.
This group would die alone without relatives available and is suf-
ficient small and sufficiently vulnerable that those formulating
public policy should bend over backward to avoid abusing their
right to be treated with maximum respect.
This brings me to the fourth and final, perhaps the most critical
question of all, that of fairness in distribution of organs once they
are procured.
Congressman Gore, in your communication to me about these
hearings, you indicated that the subcommittee was particularly in-
terested in looking at approaches to promote efficient distributions
of organs for transplant recipients. While those standing within the
religious traditions I am attempting to summarize would be con-
cerned about efficient distribution, I think they would place at
least equal emphasis on fair distribution.
For example, a Detroit newspaper some years ago carried an ad
with an offer to buy kidneys for $3,000 suitable for transplantation.
Markets in organs might just turn out to be efficient, but I am con-
vinced that they would be opposed vigorously by the mainstream of
the religious traditions I am summarizing.
They would be opposed, among other reasons, because the alloca-
tion, though perhaps efficient in maximizing the number of organs
transplated, would be grossly discriminatory against those unable
to pay.
The Judeo-Christian tradition is deeply committed to distribution
on the basis of need. A single dominant theme of both Jewish and
Christian ethics has been the responsibility to those in need: The
lame, the halt, the blind, and now those in need of organs.
Any allocation scheme that permits other variables, such as abil-
ity to pay or some judgment about how socially useful a recipient
will be, has been uniformly opposed by all of the commentators
working within these traditions.
Some unfair allocation schemes, it turns out, may not be as bla-
tant as direct market mechanisms to buy organs. Current medicare
policy, for instance, prohibits funding of heart transplants under
Government health insurance and has a similar impact of discrimi-
nating against the needy.
339
It is my sense that spokespeople for religious traditions and the
theologians writing within these traditions are realists. They recog-
nize the Government could not make a commitment to pay for all
possible medical care. That is precisely the point Alex Capron was
making. They do, however, share with the President's Commission
the conviction there should be some floor level of health care under
which no one ought to fall.
In the allocation of scarce organs for transplant, at least in such
cases as hearts, kidneys, and livers, where the organs are literally
lifesaving, allocation is simply unfair if it is based on ability to pay.
If anyone has access, all should have an equal chance, either by
some lottery system, random assignment of organs to those in
equal need, or by some randomness of having to wait in line for
needed organs.
That is the conclusion reached by virtually every theologian
working in the tradition I am summarizing. No one should get an
organ for transplant or an artificial organ for implant until there
is a fair, nondiscriminatory allocation system in place which gives
everyone any equal need for lifesaving organs an equal opportunity
for access.
Recently, we have discovered even more subtle problems of fair
and efficient allocation. What I have to say here is perhaps a bit
sensitive, and I want to state my views very carefully.
Some individuals with particular skills in reaching the medical
profession or the mass media or have been able to procure organs
for themselves or for their family members. Candice Thomas was
here earlier this morning. Those supporting her care, according to
a fundraising campaign on a local radio station, have gotten Presi-
dent Reagan to volunteer an airplane, presumably Air Force One,
to transport any donated liver.
No one can possibly criticize these parents for doing everything
possible to meet the needs of their loved ones. In fact, they have
probably increased the efficiency in organ procurement by reaching
organs that would otherwise go to waste and by increasing public
awareness.
As a society, however, I believe we should be ashamed that these
people are forced to use ad hoc techniques, personal charisma and
persuasion to obtain organs for their families. It is simply too disor-
ganized, too ideosyncratic a method. It is unfair to the families in
crisis. It is unfair to those who lack the power or the access to
those means of getting organs.
Either the use of government airplanes to meet these needs is
justified, and it should be done for all in need of organs, or it is
not, and it should not be done for any. A much more systematic,
institutional response is called for, one that in a disciplined way
makes available every organ within reach donated by a patient or
the responsible next of kin in a manner that gives all people of
equal need equal opportunity of access. I think that the Federal
Government is the only institution that can provide that kind of
systematic, fair access.
Some such organized system of fair access is called for by Jewish
and Christian traditions that I have been asked to summarize. In
principle, it seems to me that it is the public policy that has to be
recommended to this committee.
340
Thank you.
Mr. Gore. Thank you very much. That is very thoughtful and
helpful testimony. We will hold questions until Dr. Childress has
rounded out the panel.
[The prepared statement of Dr. Veatch follows:]
341
Statement of Robert M. Veatch
My name is Robert Veatch. I am the Professor of Medical Ethics at
Georgetown University's Kennedy Institute of Ethics, a research center
devoted to studying the social and ethical aspects of medicine and health
policy. I have graduate level training in neuro-pharmacology , a divinity
school degree from Harvard, and a doctorate in the study of religion and
society at Harvard where I concentrated in medical ethics. I have been
asked to review the bioethical and religious issues surrounding organ
procurement. Although I am a Methodist, I speak for no religious or
academic group and shall try to present fairly my understanding of the
views of major religious groups on the issues at hand.
The bioethical debate over organ procurement goes back at least to
the first kidney transplants in 1954. The current generation of
controversy, however, can be dated from December 3, 1967, when Christiaan
Barnard transplanted the first human heart into the chest of Louis
Washkansky. In what follows I limit my remarks to the procurement of
cadaver organs. While organ procurement from living donors, especially
related donors, appears to be acceptable in cases where the transplant
would be life-saving for a recipient and would not be life-threatening
for the donor, there is widespread disapproval of procuring organs from
living donors when the removal of the organ would be life-threatening.
342
Investigations and Oversight Subcommittee
Robert M. Veatch
April 14, 1983
-2-
In any case, I assume that cadaver organ procurement constitutes the
critical ethical and public policy problem. It is here that the most
good can be done by clarifying our ethical and religious requirements.
As I understand the contemporary bioethical debate over organ
procurement, it contains two issues I shall label as preliminary and two
issues that are central or core. The ethics of the definition of death
and the removal of cadaver organs I take to be preliminary while the
donation vs. salvaging controversy and the ethics of fairness in organ
distribution I take to be central.
All major religious groups reveal some differences of opinion over a
shift to the use of a brain-oriented definition of death, a shift
important if organ procurement is to be facilitated. Within Judaism
there has been the greatest resistance to shifting to a brain-oriented
defintion of death. Rabbi David Bleich, philosopher at Yeshiva
University, for example, opposes any shift, saying that "the patient
cannot be pronounced dead other than upon the irreversible cessation of
both cardiac and respiratory activity." On the other hand, other
Rabbis from Conservative and Reformed traditions have endorsed the use of
2
brain criteria for death pronouncement.
Among Catholics Pope Pius XII opened the door for a shift in the
definition of death in 1957 saying, "it remains for the doctor, and
especially the anesthesiologist, to give a clear and precise definition
of 'death' and the 'moment of death' of a patient who passes away in a
3
state of unconsciousness." There have never been any principled
theological objections to a brain-oriented definition of death among
Catholics although occasionally more conservative Catholics, often those
associated with right-to-life positions, have expressed fear that
343
Investigations and Oversight Subcommittee
Robert M. Veatch
April 14, 1983
-3-
aclcnowl edging that a person is dead when the brain is dead might
indirectly lessen respect for those who are still living.
Protestant theologians (and Protestant groups when they have spoken
on the subject) have almost uniformly favored some brain-oriented
definition of death whether they represent more conservative (Paul
Ramsey) or liberal (Joseph Fletcher) perspectives. Thus while there
is some concern about the use of a brain-oriented definition of death, at
least some responsible members of all major religious traditions accept
it theologically and find it appropriate as a basis for procuring cadaver
organs .
More significantly, there is substantial ethical agreement on the
second preliminary ethical question, the ethics of removal of cadaver
organs. There has in general been no objection among either the secular
or religious bioethical community to the removal of organs for
life-saving purposes from human bodies once it is established those
persons are dead. Protestants and Catholics have raised no serious
questions about cadaver organ removal provided appropriate respect is
shown for the deceased and appropriate permissions are obtained.
Jewish thought poses a more serious question since in Judaism there
o
are religious obligations to bury the dead with organs intact. This
obligation is superseded when a cadaver organ can be removed for the
purpose of saving a life of another identified person in need. Thus all
major religious traditions accept the legitimacy of removing cadaver
organs for life-saving transplantation. Some may insist on more
conservative heart-and-lung-oriented criteria for death and some,
especially Orthodox Jews, may object to organ removal for research or
educational purposes, but the two preliminary ethical problems pose no
344
Investigations and Oversight Subcommittee
Robert M. Veatch
April 1A, 1983
insurmountable obstacles for cadaver organ procurement. In fact, they
all place a high value on the saving of human life so that while the
state may not be authorized to salvage organs routinely, individuals bear
at least a moral obligation to facilitate organ procurement for
life-saving purposes.
This brings us to the two more critical and controversial core
ethical issues. First, the controversy over donation vs. salvaging of
organs. It has been recognized for years that there are two basic
alternatives for organ procurement: donation and salvaging. Under
salvaging schemes, such as that proposed by Dukeminier and Sanders,
cadaver organs would be routinely made available as needed as a social
resource.9 Normally, advocates of salvaging would permit individuals
to object in writing while living or even permit relatives to object in
cases where the individual has not expressed his or her wishes. The
other alternative emphasizes donation.
It is this second alternative that has been favored by virtually
every writer within the Judeo-Christian tradition and by every religious
group speaking on the subject. The reason is fundamentally that
according to the Judeo-Christian tradition, our respect for the
individual and the rights associated with that individual do not cease at
death. Obligations of respect — for the wishes of the deceased and the
integrity of his earthly remains--must continue. In the Judeo-Christian
tradition, as opposed to much pagan Greek, thought, the body is affirmed
to be a central part of the total spiritual being. Any scheme that
abandons the mode of donation in favor of viewing the cadaver as a social
resource to be mined for worthwhile social purposes will directly violate
central tenets of Christian thought and create serious problems for Jews
345
Investigations and Oversight Subcommittee
Robert M . Veatch
April 14, 1983 -
-5-
as well, especially in a state not based on Jewish law. It will, more
pragmatically, predictably produce vociferous, agitated opposition.
While I cannot predict street riots comparable to those sparked in Israel
after the passing of autopsy laws permitting routine violation of the
corpse, it is safe to say there would be sustained and vocal
opposition.
At the same time there is uniform support in all major traditions not
only for the ethical acceptability of donation, but the actual moral
obligation to take organ donation seriously. This suggests while, for
practical and theoretical reasons, all traditions would oppose routine
salvaging, they would look favorably upon public policies to make
donation as easy as possible. Given the fact that these religious
traditions all support organ donation in at least some circumstances and
in fact consider it a morally weighty obligation, they would favor public
policies making it as easy as possible to express a willingness to donate
organs for life-saving purposes.
The public policy implication is that the correct solution to the
donation vs. salvaging controversy is maximum encouragement to facilitate
donation, provided this does not subtly coerce those unwilling to donate
or does not trick them into donating unintentionally. The schemes to
indicate willingness to donate on state drivers* licenses, for example,
would seem very reasonable. In addition, questions on federal documents,
especially those already computerized for easy retrieval such as income
tax or social security records, would seem appropriate. The ideal form
of the question about willingness to donate would permit three
responses--yes, no, and no response — thus not creating any presumptions
or pressures on any respondents. This strategy seems far preferable to
346
Investigations and Oversight Subcommittee
Robert M. Veatch
April 14, 1983
-6-
continental European public policies authorizing routine salvaging unless
12
objection has been registered. It is even preferable to the scheme
endorsed by the British Working Party of the Health Departments of Great
Britain and Northern Ireland, which would give a designated government or
hospital official the power to remove organs for transplantation in cases
where no objection has been registered and relatives cannot be
located.1 This group who die alone, without relatives available, is
sufficiently small and sufficiently vulnerable that those formulating
public policies should bend over backwards to avoid abusing their right
to be treated with maximum respect.
This brings us to the final critical question: fairness in the
distribution of organs once they are procured. Congressman Gore, in his
communication to me about these hearings, indicated that the subcommittee
was particularly interested in looking at approaches to promote efficient
distribution of organs to transplant recipients. While those standing
within the religious traditions I am attempting to summarize would be
concerned about efficient distribution, I think it is clear that they
would place at least equal emphasis on the problems of fair distribution.
For example, there have from time to time been casual references to
the use of market mechanisms to promote efficient transfer of organs to
recipients. A Detroit newspaper some years ago carried an ad with an
14
offer to buy a kidney for $3,000. Markets in organs might turn out
to be efficient, but I am convinced they would be opposed vigorously by
the mainstream of these religious traditions. They would be opposed
because the allocation, though perhaps efficient in maximizing the number
of organs transplanted, would be grossly discriminatory against those
unable to pay. The Judeo-Christian tradition is deeply committed to
347
Investigations and Oversight Subcommittee
Robert M. Veatch
April 14, 1983
-7-
distribution on the basis of need. The single dominant theme of both
Jewish and Christian ethics has been the responsibility to those in
need--the lame, the halt, the blind, and those in need of organs. Any
allocation scheme that permits other variables such as ability to pay or
some judgment about how socially useful a recipient will be has been
uniformly opposed by all commentators working from within these
.... 15
traditions.
Some unfair allocation schemes may not be as blatant as direct market
mechanisms to buy organs. Current Medicare policy prohibiting funding of
heart transplants under government health insurance has a similar impact
of discriminating against the needy. It is my sense that
spokespeople for religious groups and theologians writing within these
traditions are realists. They recognize that the government cannot make
a commitment to pay for all possible medical care. They do, however,
share with the President's Commission for the Study of Ethical Problems
in Medicine and Biomedical and Behavioral Research the conviction that
there should be some floor level of health care under which no one ought
to fall. In the allocation of scarce organs for transplant, at least
in cases such as hearts, kidneys, or livers, where the organs are
literally life-saving, allocation is simply unfair if it is based on
ability to pay. If anyone has access, all should have an equal chance,
by some lottery system, random assignment of organs to those in equal
need, or by the randomness of having each wait in line for needed
organs. That is the conclusion reached by virtually very theologian
writing out of the Judeo-Christian tradition and, I am convinced, the
only one they can reach and be consistent with that tradition's
commitment to equal treatment based on need. No one should get an organ
348
Investigations and Oversight SuDcommittee
Robert M. Veatch
April 14, 1983
-8-
for transplant (or an artificial organ for implant) until there is a
fair, non-discriminatory allocation system in place which gives everyone
in equal need for life-saving organs an equal opportunity of access.
Recently we have discovered even more subtle problems of fair and
efficient allocation. Some individuals with particular skills in
reaching the medical profession or the mass media have been able to
procure organs for themselves or their family members. Those supporting
a small child in need of a liver transplant have even, according to a
fund-raising campaign for a local radio station, gotten President Reagan
to volunteer Air Force One to transport any donated liver. No one can
possibly criticize them for fulfilling their obligations to themselves
and their loved ones to do everything reasonable to serve their needs.
In fact, they probably increase efficiency in organ procurement by
reaching organs that may otherwise go to waste and by increasing public
awareness of the need for organs. As a society, however, the use of such
ad hoc techniques of personal charisma and persuasion to obtain organs
should be viewed with skepticism. It is simply too disorganized, too
idiosyncratic a method. It is unfair to those who lack the power or
access to these means of obtaining organs. Either the use of government
airplanes for organ transportation is justified and it should be done for
all organs, or it is not and and it should not be done at all. A much
more systematic, institutional response is called for, one that in a
disciplined way makes available every organ within reach donated by the
patient or the responsible next of kin in a manner that gives all people
of equal need an equal opportunity of access. I think the federal
government is the only institution that can provide that kind of
systematic, fair access. Some such organized system of fair access is
called for by the Jewish and Christian traditions that I have been asked
to summarize. It is the principle of a public policy that I would
recommend to this committee.
349
REFERENCES
1. J. David Bleich, "Neurological Death and Time of Death Statutes,"
Jewish Bioethics, ed . Fred Rosner and J. David Bleich (New York: Sanhedrin
Press, 1979), p. 310.
2. Fred Rosner, "Organ Transplants: The Jewish Viewpoint," Journal of
Thanatology 3 (1975): 233-41.
3. Pius XII. "The Prolongation of Life." An Address to an International
Congress of Anesthesiologists on November 24, 1957. The Pope Speaks 4 (Spring
1958): 396.
4. Paul A. Byrne, Sean O'Reilly, Paul M. Quay, "Brain Death—An Opposing
Viewpoint," Journal of the American Medical Association 242 (November 2, 1979):
1985-90.
5. Paul Ramsey, "On Updating Procedures for Stating that a Man Has Died,"
The Patient as Person (New Haven, Connecticut: Yale University Press, 1970),
pp. 59-112.
6. Joseph Fletcher, "Cerebration," Humanhood: Essays in Biomedical Ethics
(Buffalo, N.Y.: Prometheus Books, 1979), pp. 159-65.
7. Paul Ramsey, "Giving or Taking Cadaver Organs for Transplant," The Patient
as Person, esp. pp. 205-09; Ethical and Religious Directives for Catholic Health
Facilities. Directive 30 (Washington, D.C.: Dept. of Health Affairs, United
States Catholic Conference, 1971), p. 8; Benedict M. Ashley and Kevin D. O'Rourke,
Health Care Ethics: A Theological Analysis. 2nd edition (St. Louis, Mo.: The
Catholic Health Association of the United States, 1982), pp. 308-12.
8. Paul Freund, "Organ Transplants: Ethical and Legal Problems," Proceedings
of the American Philosophical Society 15 (August 1971) :276; Fred Rosner, "Organ
Transplantation in Jewish Law," Jewish Bioethics. esp. p. 360.
23-029 0-83-23
350
9. Jesse Dukeminier and David Sanders, "Organ Transplantation: A Proposal
for Routine Salvaging of Cadaver Organs," New England Journal of Medicine 279
(1968) : 413-19.
10. Robert M. Veatch, "A Policy for Obtaining Newly Dead Bodies and Body Organs,"
Death, Dying, and the Biological Revolution (New Haven, Cr .. : Yale University
Press, 1979), pp. 266-76.
11. Fred Rosner, "Autopsy in Jewish Law and the Israeli Autopsy Controversy,"
Jewish Bioethics, p. 343.
12. "France Widens Authority for Transplants from Dead," New York Times,
April 16, 1978, p. 11. Cited in Medical Care Review 35 (May 1978): 512.
13. The Removal of Cadaveric Organs for Transplantation: A Code of Practice.
Document drawn up by a Working Party on Behalf of the Health Departments of Great
Britain and Northern Ireland. October 1979.
14. "$3,000 Offer for Kidney Brings Man 100 Donors," New York Times,
September 12, 1974, p. 36.
15. Gene Outka, "Social Justice and Equal Access to Health Care," Journal of
Religious Ethics 2 (Spring 1974): 11-32; James F. Childress, "Who Shall Live
When Not All Can Live?" Soundings 53 (Winter 1970): 339-54.
16. U.S. Health Care Financing Administration, "Exclusion of Heart Transplantation
Procedures from Medicare Coverage," Federal Register 45 (August 6, 1980): 52296-97.
17. President's Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research, Securing Access to Health Care: The Ethical
Implications of Differences in the Availability of Health Services. Vol. 1: Report
(Washington, D.C.: U.S. Government Printing Office, March 1983), p. 4.
351
Mr. Gore. Dr. Childress, we are honored to have you here today.
We invite you to proceed.
Dr. Childress. Mr. Chairman and members of the committee,
thank you very much for this opportunity to testify.
So far, our society has failed to provide an adequate supply of
organs that can be transplanted to save many lives, but this scarci-
ty is not absolute, as we have heard today. Each year in the United
States there are more than enough deaths, under conditions that
would permit the salvage of organs, to provide a surplus of organs-
there are approximately 20,000 such deaths. Unfortunately, most of
those organs are wasted.
It is not too difficult, as we have heard today, to secure organs
for dramatic cases involving identified lives, such as Jamie Fiske,
but not everyone can generate that publicity. It may be neces-
sary—indeed, I think it probably is— to change our policies in order
to increase the supply of organs for unidentified strangers.
The question is whether we can increase the supply of organs for
transplantation, which is an ethically desirable goal and, as Profes-
sor Veatch has reminded us, is consistent with the Judeo-Christian
tradition, without violating other important moral principles and
values, such as respect for persons and their wishes and principles
of justice or fairness in the distribution of benefits and burdens in
the society.
I want to concentrate on obtaining cadaver organs and then
make a few comments about living donors before concluding by
identifying some other problems that we need to face.
First, cadaver organs. Currently, in all 50 States, under the Uni-
form Anatomical Gift Act, individuals may sign a donor card to
consent to the use of their organs after their deaths or their fami-
lies may consent.
Although there is a lot of controversy about this, according to
the studies I have seen, very few people— the studies indicate be-
tween 1.5 percent and 19 percent— ever bother to sign their donor
cards. It may be very difficult for physicians to ask a family for
permission or for the family to grant permission after the patient
has died, if the patient has not earlier indicated his or her wishes.
Several possible approaches have been suggested for obtaining
cadaveric organs. The first would be to keep the Uniform Anatomi-
cal Gift Act as it is, but to educate the public and to educate and to
organize professionals in order to obtain more organs.
I would agree with the emphasis on education of the public and
education of professionals. It is not at all clear how effective this
will be, but it will nevertheless be very important within any ac-
ceptable policy.
Regarding organization, the Centers for Disease Control studied
the establishment of a recruitment network that over a 3-year
period had a remarkable success rate of increasing the donation of
organs by eight- or nine-fold.
I think it is important to note in that particular study that ap-
proximately 50 percent of the families who were asked to donate
organs of their deceased relatives refused to give consent. Thus, in
addition to organization, I think we will need to pay some attention
to revisions in the Uniform Anatomical Gift Act.
352
Two such revisions might be considered. First, we might require
a decision for or against organ donation of all adults. I don't think
there can be a major ethical objection to this policy. It is consistent
with principles of respect for persons and justice to require people
to make a decision for or against donation. They would not be
forced to decide for donation; they would only be forced to make a
decision.
Second, I would even be willing to consider from an ethical
standpoint the possibility of moving to a system of presumed con-
sent, ^ :_e so-called routine salvaging of organs or harvesting organs,
except where there has been prior objection by the deceased person
or where there is objection by the family.
This is the system that has already been described as contracting
out rather than contracting in.
Mr. Gore. Opting out, I think.
Dr. Childress. Both contracting out and opting out. Both terms
are used interchangeably.
Mr. Gore. Thank you.
Dr. Childress. This is the practice in several countries, including
Denmark, France, Israel, Italy, Norway, Spain, Sweden and Swit-
zerland, among others. Sometimes this system of opting out or con-
tracting out is combined with the use of donor cards and with at-
tention to family objections.
In the countries mentioned there are still some shortages of
organs, but they come closer to meeting the needs, for example, for
transplant kidneys than our own country does.
I think all three approaches to obtain cadaveric organs are ethi-
cally acceptable— the Uniform Anatomical Gift Act, requiring a de-
cision, or presuming consent. They all seek a morally desirable goal
without violating fundamental moral principles.
Nevertheless, I agree with Robert Veatch that it would be ethi-
cally preferable to keep the Uniform Anatomical Gift Act, the
policy of giving and receiving that emphasizes voluntary generosity
and altruism, other things being equal. But I think that this policy
has not proved to be adequate to meet our needs.
Next in rank order, but still ethically acceptable, would be a
policy of requiring a decision and finally a policy of presuming con-
sent. I would emphasize that I believe they are still ethically ac-
ceptable even if the Uniform Anatomical Gift Act is preferable.
Then I think we should consider which one of these might be the
most effective and efficient in obtaining organs as long as, again,
we are not violating fundamental ethical principles. It would, how-
ever, be ethically unacceptable simply to take organs without
regard to prior wishes or current objections. No one really proposes
that.
A few comments about living donors, who are especially impor-
tant in kidney transplantation and bone marrow transplantation.
For example, in renal transplantation approximately 30 percent of
the kidneys come from living donors, most often living-related
donors.
In general, the trend over the last several years away fom the
use of kidneys from living donors is to be applauded because it
avoids risks to healthy persons. But in some situations living
donors, especially related living donors, may be the best sources, if
353
we can be sure that those donors are competent to consent, are in-
formed, and are choosing voluntarily. To exlude them categorically
would be unwarranted paternalism. Yet, a policy of obtaining or
seeking cadveric kidneys wherever possible is morally preferable.
In my written testimony, I discussed two classes of family mem-
bers who are especially problematic as donors: Preadolescent chil-
dren and mentally retarded persons. I will not discuss them here.
Let me make one comment about living, unrelated donors. Few
kidneys from such donors have been accepted since 1970, perhaps
because of a widespread suspicion that such persons are unbal-
anced because they want to make such a donation to people who
are not their relatives and who are perhaps even strangers.
Yet, some polls indicate that approximately half of the people in-
terviewed think that there is an even chance that they would
donate a kidney to a stranger while they are alive. So, I think we
should not categorically exclude such individuals if, again, they are
competent, informed, and choosing voluntarily.
Regarding the sale of organs from living donors or from newly
dead persons, neomorts as they are sometimes called, I think it is
important to note that the sale of organs is not clearly prohibited
in most states. It has been reported in other countries, and there
are advertisements, as already noted, in many places in the United
States.
I think that the sale of organs should be prohibited for the rea-
sons that Professor Capron indicated, especially to prevent abuses
and to prevent exploitation in a society with great differences in
the distribution of wealth.
Finally, let me identify a couple of problems that need further
attention.
First, people frequently do not sign their donor cards because of
forgetfulness. Furthermore, less than 20 percent of the population
at large have wills when they die. I think that in the area of organ
donation there is also the element of fear and distrust of medical
professionals and institutions, fueled perhaps by such movies as
Coma. There is a fear of being declared dead prematurely in
order to benefit others.
I am not sure that the educational and organizational procedures
suggested earlier or the changes proposed in the Uniform Anatomi-
cal Gift Act would really reduce fear and distrust. I am not sure
how this can be done, but I think it is an important problem if we
are really going to increase the supply of organs.
Mr. Gore. Doctor, I think that is an important problem, too.
Even if it is often unstated or unarticulated, I think that is in the
back of the mind of a lot of people who use it not as a factor in
making an explicit decision but as almost an unconscious factor in
deciding not to decide, in not facing the question because of that
lingering doubt or fear.
Do you agree with that?
Dr. Childress. I do, indeed. Earlier this week I was making a
presentation at the West Virginia University Medical Center and
had a chance to talk to several chaplains who are involved not only
in hospital care, but also in local congregations. They have faced
such problems with members of their religious communities, and
354
they reported that fear and distrust emerge again and again in the
reservations their parishioners have about organ donation.
Mr. Gore. Yesterday we heard some statistics showing that ac-
cording to the National Kidney Foundation's new Gallup poll, the
percentage for black Americans who felt like they might become
donors was just half that of the percentage of white Americans.
It occurred to me at that time that the historical and traditional
view of society's institutions that is unique to the black community
might have contributed to that feeling that we were just discussing
and might account for the dramatic difference in the polling re-
sults.
Dr. Childress. I think that is a very important observation. It
would be interesting to know if other people who feel themselves
similarly on the margins of society, perhaps economically dispos-
sessed, would have similar reservations or little confidence in the
medical profession and institutions in society.
Mr. Gore. It seems to me that as the medical community decides
how it is going to approach this question — and some of the doctors
here yesterday said that the medical community itself has to do a
great deal more — it ought to at least consider how it might address
that lingering fear and come up with some sort of absolutely fail-
safe guarantees that there will be no basis whatsoever for those
fears and get that message out. It might really be a bottleneck in
holding back the solution to this problem. It is something that I
think is worth a good deal of attention.
Dr. Childress. I think so, and the mere provision of information
that I talked about under the heading of education would not be
sufficient. Something else has to occur. We might note that histori-
cally the move to update the criteria for determining death was in
part influenced by the need to obtain organs for transplantation.
That influence was enough to create some suspicion and distrust on
the part of individuals.
Mr. Gore. There is a movie out now, I haven't seen it yet, and I
don't know if anyone has seen the new Monty Python movie. Often
humor plays on some unconscious fears. I am told, although I
haven't seen it, that one of the skits in the movie is someone walk-
ing up and asking individuals if they have an organ donor card.
When they respond positively, the character pulls out a gun and
shoots him right on the spot. This is presented as a humorous skit
in this movie.
The reason it is humorous I think probably has to do with this
lingering attitude that probably does play a significant role here.
Please go ahead.
Dr. Childress. I will finish with some comments about one more
problem; that is the problem of the allocation of society's resources
and the allocation of scarce organs. Professor Capron raised this
issue. I am not sure where I come down on this issue, but I would
agree with him that it is complicated and needs the most careful
attention.
For example, society now provides practically universal coverage
for renal dialysis and renal transplantation. That decision was
made in the early seventies, and now a lot of people are raising
questions about whether our society can afford the tremendous
costs of the program.
355
I would suggest that in all of these areas of technology and trans-
plantation it is important to ask the question about how society's
scarce resources should be allocated, for example, as Professor
Capron suggested, between health care and other goods.
But also, within health care, should we concentrate on technol-
ogies for cirtical care or chronic care, or should we concentrate on
prevention? It seems to me that this is the kind of question that
would have to be faced in an overall societal policy about health
care because we might be able to save more lives statistically in
the long run if we concentrated on prevention rather than on some
forms of critical care. This issue would have to be settled at on a
case-by-case basis.
It is important to build on the kind of compassion you described,
but also to see how that compassion has to be filtered through a
perspective that considers the whole range of health problems in
the society and statistical as well as identified lives.
In terms of the other part of the allocation question — the alloca-
tion of organs to recipients when the supply is limited — I think
that we probably have had fewer problems in this area than in the
allocation of artificial organs partly because to allocate organs for
transplantation it is necessary to get a good match, that is, to look
at the medical need, but also to look at the probability of a success-
ful transplant. Thus, there is a tendency to emphasize medical cri-
teria.
I think that these criteria are important and acceptable, but
when we have to move beyond medical criteria, as Professor
Veatch has rightly indicated, we should not make judgments of
social worth or social value. We should rather use some form of
randomization or queuing or "first come, first served" in order to
build in a kind of equality of opportunity that respects persons as
persons and accords them equal value.
Thank you very much.
[The prepared statement of Dr. Childress follows:]
356
The Gift of Life: Ethical Problems and Policies in Obtaining
Organs for Transplantation
James F. Childress
Professor of Religious Studies and
Professor of Medical Education
University of Virginia
Charlottesville, Va. 22903
Several transplanted organs and tissues can increase a
recipient's chances of survival or improve a recipient's quality
of life. Yet the supply of organs and tissues is inadequate to
meet the need and demand for transplantation. Enough cadaveric
organs exist, but the society has not yet found an effective,
efficient, and morally acceptable way to obtain them. The
Council of Scientific Affairs of the American Medical Association
has helpfully described our situation:
Organs removed from a cadaver after breathing and
heart action have ceased have sustained serious ischemic
injury and, except for cornea, bone, and skin, are
rarely suitable for transplantation. Death from
brain injury, tumor, or infraction may permit hours
or days of normal circulation, especially if controlled
mechanical ventilation is maintained, which will allow
preservation of heart and kidney until they can be re-
moved, cooled, and properly preserved for transplantation.
There are more than enough deaths in the United States
(estimate, 20,000) to provide a surfeit of organs, if
tEere were a satisfactory method of bringing all sucn
cadavers into the pool of donors. Now that tnere is a
cadaver graft survival of transplanted hearts or kidneys
of 50% to 70% and kidney host survival of up to 90% for
two years, it has become important that our society find
ways to improve donor recruitment.1
357
Such a dramatic case as Jamie Fiske's can temporarily direct
the public's attention to the need for organs. Many potential
donors respond enthusiastically to dramatic cases involving
identified lives, but changes in public policies may be necessary
to increase the supply of organs for unidentified strangers.
Some changes in policies can be expected to increase the supply
of organs and tissues and can be implemented without violating
important ethical principles and values.
Currently in all fifty states the Uniform Anatomical Gift
Act allows us to determine what will be done with our organs
donor
after our deaths. If we do not sign a / card, available in many
states with the driver's license, our families may consent to
donate our organs after our deaths. According to some opinion
polls, as many as 70% of the adult population say that they are
willing to have their organs used for transplantation after they
die, but very few (between 1.5% and 19%, according to some
2
studies) actually sign donor cards. Furthermore, families
frequently find it very difficult to donate organs after the
death of a loved one, and physicians and other health care
professionals may be reluctant to raise the question of organ
donation.^ In this situation, which policies might increase the
supply of organs - a morally desirable goal - without violating
other moral principles and values?
In assessing various policies, I will emphasize the following
moral principles and values: (1) Not harming others (sometimes
called the principle of nonmalef icence) ; (2) Benefitting others
(sometimes called the principle of beneficence); (3) Producing
358
the greatest good for the greatest number (sometimes called the
principle of utility); (4) Distributing benefits and burdens in
a fair or equitable way (sometimes called the principle of justice) ;
and (5) Respecting personal wishes, choices, and actions (sometimes
called the principle of autonomy or the principle of respect for
persons). I cannot argue for these principles here, but they are
widely accepted as morally relevant to an assessment of actions,
practices, and policies in science, medicine, and health care.
They can be discerned in various deliberations about policies; for
example, they appear (in somewhat different form) in the
deliberations of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research. Proposals
to change policies in order to increase the supply of organs
usually appeal to principles #1, 2, and 3, particularly utility.
Arguments against such policies frequently appeal to principles
#4 and 5, particularly autonomy or respect for persons. Thus,
while all of these principles are relevant to the policies under
consideration, I will concentrate on utility and autonomy or
respect for persons.
359
I will argue that an effective and efficient system for obtaining cadaveric
organs (organs from the "newly dead" or "neomorts") can reduce and perhaps even
eliminate scarcity without violating other principles such as justice and re-
spect for persons. Within the range of ethically acceptable systems of organ
procurement, some may be ethically preferable or ideal without being mandatory.
It may be ethically preferable to retain our current laws regarding organ do-
nation and to reduce scarcity through educational and organizational efforts.
But such educational and organizational efforts, which would be expensive, would
probably need to be supplemented by changes in the Uniform Anatomical Gift Act.
It would be ethically acceptable to (a) require each adult to make a decision
about the use of his or her organs after death, or (b) to presume consent to
organ removal after death unless the person has previously registered his/her
dissent or his/her family dissents. It would be ethically unacceptable simply
to take organs from the decedent without regard to the decedent's prior wishes
or the family's wishes. After considering ethically acceptable approaches to
obtaining cadaveric organs, I will examine policies regarding living donors.
Cadaveric Organs : Educational and Organizational Efforts
within the Current Legal Structure
^Education of the public. Policies of educating the public about the need and
importance of gifts of life should not be underestimated. Some people fail to
sign their donor cards because of forgetfulness; others may mistrust medical
institutions and professionals, fearing that they will be declared dead pre-
maturely so that their organs can be retrieved for others. There is a clear
the
need for educational activities that would alert the public to/need for organs
and explain the whole process, including the determination of death. Nevertheles
such educational activities cannot be expected to reduce scarcity significantly
without other changes.
360
Education and Organization of Physicians and Other Health Care Pro-
fessionals. Physicians and other health care professionals need to be
educated about the need for organs for transplantation so that they will
actively seek to increase the supply. It is not easy for physicians who
have "lost" a patient to start thinking about how that dying or dead
patient's "parts" might benefit others. Nevertheless, once it is clear
that the patient will not survive or is brain dead, the neurosurgeons and
neurologists (who see most potential donors) should actively seek to benefit
other patients by alerting the appropriate team. As some commentators have
argued, "the only goal of the neurosurgeon must be the full treatment of
a potentially salvageable patient, /~but_7 once brain death has occurred
a more general responsibility become operant, namely to identify potential
donors and avoid wastage of organs . " -*
This educational activity needs to be combined with organizational
activities to increase the identification of potential donors and to
arrange transplantation. The value of organizational activities can be
seen in the study of a group of physicians at the Centers for Disease
Control in Atlanta. These physicians organized a "recruitment network"
to relate the transplant team to certain hospital areas, such as the
intensive care units, through a transplant nurse -coordinator. During
6
the 2 l/2 year study, the number of actual donors increased by ninefold.
Obviously, both educational and organizational activities are expensive.
Successful efforts will be costly, and they will presuppose some judgments
about priorities in the allopation of resources within the health care system.
It would be inadequate to undertake one effort without the other. For example
7
in the CDC study, family consent was received only about half of the time.
Hence it is necessary to combine education of the public with education and
organization of health care teams. But both would be more effective if
donor laws required a decision about donation by all adults or presumed
consent from adults who have not objected (or whose families do not object).
361
Cadaveric Organs: Changes in the Uniform Anatomical Gift Act
Two possible changes in the Uniform Anatomical Gift Act merit careful
attention; either could help to increase the supply of organs for transplantation
without violating principles of justice or respect for persons.
Requiring a decision. If few donor cards are signed because of inadvertence
or f orgetf ulness , the law could be changed to require everyone above a certain
age to make a decision for or against the use of his/her organs after death.
Our society rightly wants to avoid making people decide to donate their organs,
but there is no ethical objection to requiring them to make a decision for or
against such donation. Obviously, such a change in state laws might not
lead to a dramatic increase in affirmative decisions about organ donation without
the educational efforts mentioned above. Furthermore, the increased use of
organs would depend on increased professional activity and organization. But
in conjunction with efforts to educate the public and to educate and organize
physicians and others, this change in legislation could be very effective. And
it does not violate standards of justice and respect for persons; indeed,
personal wishes and choices are determinative.
Presuming consent (sometimes called "routine salvaging of organs" or
"harvesting organs"). Both the Uniform Anatomical Gift Act and a law requiring
a decision involve "contracting in," and both should be ranked above this system
of "contracting out."° But a system of presumed consent is not ethically unacceptable.
Recognition of presumed consent (or tacit consent) as the basis for organ removal
after a person's death does not violate principles of justice and respect for
persons, if that person had an opportunity to dissent. It has been argued that
"presumed consent would ... be in keeping with traditional humanist values by
making the basic presumption one that favors life and by putting the burden of
objecting upon those who would deny life to another. The policy of saving human
life would be given first priority, yet the wishes of persons to preserve a
362
9
corpse inviolate would also be accommodated." In short, presumed consent
(or tacit consent) enables the society both to realize utility and to respect
persons. Even though presumed consent would not emphasize voluntary gifts
(as in the Uniform Anatomical Gift Act or a statute requiring a decision), it
would not authorize actions against a person's express wishes.
Presumed consent laws exist in a number of countries, including Denmark,
France, Israel, Italy, Norway, Spain, Sweden, and Switzerland. In approximately
half of the countries with presumed consent statutes, physicians also determine
whether the family has an objection to organ removal. Some countries recognize
10
both donor cards and presumed consent.
How effective are presumed consent laws in reducing scarcity of organs
for transplantation? All countries with presumed consent laws still have
waiting lists for renal transplantation, but they "seem to come closer to meeting
their needs for transplant kidneys . Presumed consent will probably not be
effective without vigorous efforts to educate physicians and other health
care professionals and to organize procurement of organs. It will not be
ethically acceptable without education of the public about the options, and
widespread objections ("opting out") can be expected unless the public realizes
the need for organs and trusts the medical profession and institutions. Finally,
at least in the United States, a policy of presumed consent ought to be combined
with donor cards and family approval. But a policy of presumed consent
should make it easier to seek and to gain family approval.
363
Living Donors
So far I have concentrated on cadaveric organs, examining
current and possible policies to increase the supply of such organs
and ranking those policies according to several moral principles.
But for some tissues and paired organs, such as kidneys, it is
possible to use living persons as donors. Some recent controversial
cases have involved bone marrow transplantation. In one such
case a judge refused to order a man to complete the tests he
had started and to donate bone marrow to save his cousin's life
12
if he proved to be histocompatible. The principle of respect
for persons, and derivative rules such as privacy, dictate a
policy of not removing tissues or organs from a person's body
against that person's will even to save someone else's life.
This principle is recognized in both morality and law. It is
sometimes interpreted to permit removal of organs from an incompetent
person, such as a minor or retarded person, but often in those
cases the explicit rationale is that the "donor" will also benefit
(e.g., by not losing a close sibling). In such cases, proxy
consent is required.
In the area of renal transplantation, there has been a clear
trend to accept fewer donations from living persons. For example,
in 196 7, 56% of the transplanted kidneys came from cadavers, while
13
in 1973, 70.4% came from cadavers. That trend has continued.
Qn the one hand, that trend should be applauded insofar as it
avoids risks to the health of living donors and risks of
manipulation and coercion within a family to get a reluctant donor
364
to give a kidney to a family member. On the other hand, that
trend may represent unwarranted disrespect for a potential
donor's wishes and choices, which may be adequately informed
and voluntary.
The reluctance to use living donors may stem from beliefs
about the risks of kidney donation, from worry about the lack of
understanding and voluntariness of potential donors, and from
fear of malpractice suits. Removing a kidney from a living
donor is an atypical medical procedure: It is performed to provide
medical benefit for another patient, not for the donor himself
or herself. Thus, the risk-benefit calculus mainly involves
medical risks for the donor and medical benefits for the recipient
(though there may, of course, be nonmedical benefits for the donor
and medical risks for the recipient) . While kidney donors
accept risks from the surgical removal of a kidney as well as from
living with only one kidney, their survival rates do not appear
14
to differ from those of nondonors. Furthermore, a competent
and informed donor may voluntarily accept such risks without
paternalistic intervention. Of course, many potential living
donors may be incompetent to consent to such a procedure or may
be under severe pressure and even coercion especially within a
generally
family context. Such persons/ should not be accepted as donors, ,j
C
N Where the risks are minimal
to a particular donor, who is competent, informed, and willing
to donate, a signed consent form should be sufficient to protect
the physician from a malpractice suit.
365
10
While these points hold, in general, for both living related donors and
living nonrelated donors, it is useful to distinguish the two groups.
Living related donors . In general, "donor grafts from siblings and
parents show superior functional success over cadaver grafts.' ^ But this
source could not meet the need for kidneys in the population: "Eighty per cent
of potential recipients have relatives who are unsuitable donors because of
antigenic incompatibility, kidney disease, and renal anatomical problems . "^
Thus, living related donors constitute an important but insufficient source
of kidneys for transplantation.
The major ethical concerns about living related donors who are competent
to consent focus on their understanding of the risks and their willingness to
undergo the surgical procedure and to accept the risks. Some studies show that
family members frequently decide to donate a kidney when they hear that a
relative needs one, even before they have been informed about the risks.
Furthermore, such donors frequently use the language of "necessity" to describe
their choice: "I could not have lived with myself if I had failed to donate,"
27
or "I had no choice.' Neither deciding before being informed nor using the
language of necessity invalidates the consent. The donors may have decided
that their reasons for donating (e.g., to save a relative's life) outweighed
the risks that were disclosed to them, and their languags of necessity may
simply indicate the importance of their reasons for donation. Of course,
judgments about the adequacy of a donor's information, understanding, and
voluntariness can only be made in the situation, and professionals need to be
sensitive to inadequacies on any of these levels, perhaps especially to subtle
signs of coercion from other members of a family. In such settings, physicians
sometimes provide a "medical excuse" for potential donors under severe
-I Q
external pressure to donate.
23-029 0-83-24
366
li
Two classes of living related donors are especially controversial because
their autonomy is seriously limited and even nonexistent in some cases:
children (especially preadolescent children) and mentally retarded persons.
Because of the limitations on their capacity to give valid consent, it may
be unjust to impose the burdens and risks of kidney removal on them in order
to benefit some other member of the family. The counterargument is that even
though children and mentally retarded persons lack the capacity to give valid
consent to organ removal, they can sometimes assent to (or dissent from) such
a procedure, and, more importantly, they frequently derive significant nonmedical
benefits from "organ donation." These benefits may result, for example, from
the survival of a family member who contributes greatly to the "donor's"
well-being and happiness .^ There are reasons to be suspicious of claims
about such benefits in many cases, but it is unclear to me whether all uses
of children or mentally retarded persons as "organ donors" for other members
of the family should be categorically prohibited. At the very least, there
should be independent, judicial review of the proposal to remove an organ
from such an incompetent, dependent, and vulnerable person. This review
should determine whether the heavy presumption against using such a person
as a "donor" can be rebutted, perhaps because of significant nonmedical benefits
to him or her.
Living nonrelated donors . There has also been a trend away from the
use of living nonrelated donors. Since 1970 few kidneys have been obtained
20
from living nonrelated donors for transplantation. Apparently there is a
suspicion that people who want to donate a kidney to an unrelated person,
perhaps even a stranger, are mentally unbalanced. Nevertheless, according
to one poll, only k6% of those surveyed thought that there was less than an
even chance that they would donate one of their kidneys to a stranger in need;
only 2k% definitely ruled it out.21 Polls are notoriously unreliable, and there
is often a conflict between what people say they would do and what they actually
367
12
do. But such evidence suggests that living nonrelated donors need not be
categorically excluded. Decisions about their acceptability
should be made on a case -by-case basis.
The sale of organs . On occasion, the media present dramatic stories of
people wanting to sell organs, such as kidneys and cornea, in order to raise
money for themselves or for their families. The sale of organs has been re-
22
ported in some countries, and it does not appear to be illegal in most states.
Earlier studies indicated that a policy of buying and selling blood is in-
23
efficient and increases risks for the recipient. There may be good reasons
to prohibit the sale of bodily parts. Many of these reasons concern justice,
respect for persons, and the society's sense of itself. For example, it is
sometimes argued that prohibition of the sale of- organs is necessary to prevent
exploitation in a society of great differences in the distribution of wealth.
Serious abuses could be expected in a system of buying and selling organs,
whether from one ' s own body or from cadavers .
Conclusions
The scarcity of organs for transplantion is not absolute. Each year enough
people die under conditions that would permit the salvage of enough organs to
meet the needs for transplantation. Utility would dictate changes in policies
to obtain more organs, and such changes can be made without sacrificing other
important moral principles such as justice and respect for persons.
First , there should be efforts to increase the supply of cadaveric organs ,
but living related and nonrelated donors, who are competent, informed, and
acting voluntarily, should not be excluded in such areas as kidney donation.
Second, a system of taking organs without regard for the wishes of the decedent
and his/her family is ethically unacceptable as a violation of the principle of'
368
13
respect for persons. Third, the principles of justice and respect for persons
require caution and perhaps even prohibition of the use of children and
mentally retarded persons as "donors," even when they stand to gain nonmedical
benefits. At the very least, strong procedural standards should be required.
Fourth, there are good reasons to be suspicious of the sale of bodily organs
and perhaps even to prohibit it altogether.
Concentrating on the most important source of organs — cadavers — I
argued that a multifaceted approach is required. Whether we retain or modify
the Uniform Anatomical Gift Act, more education of the public and medical
professionals is essential, and improvements in organization are required.
Public funds should be allocated for these measures. Even if the Uniform
Anatomical Gift Act is morally preferable (ceteris paribus) because of its
emphasis on voluntary giving, it is morally acceptable to change state laws
to (a)require a decision for or against donation, or (b) presume consent for organ
donation in the absence of a prior dissent or familial dissent. All three
approaches — the Uniform Anatomical Gift Act, requiring a decision, and
presuming consent — satisfy the criteria of justice and respect for persons.
Which one should be adopted will thus depend on an assessment of utility.
369
Notes
1. Council on Scientific Affairs, "Organ Donor
Recruitment," Journal of the American Medical Association
246 (Nov. 13, 1981) : 2157.
2. Howard H. Kaufman, et al., "Kidney Donation: Needs
and Possibilities," Neurosurgery 5 (1979): 237, 240; Frank P. Stuart,
Frank J. Veith, and Ronald E. Cranford, "Brain Death Laws
and Patterns of Consent to Remove Organs for Transplantation
from Cadavers in the United States and 28 Other Countries,"
Transplantation 31 (1981): 239. It has also been noted that
more than 80% of all decedents leave no wills.
3. Stuart, Veith, and Cranford, "Brain Death Laws...."
p. 240.
4. These principles have been defended in Tom L. Beauchamp
and James F. Childress, Principles of Biomedical Ethics (New York:
Oxford University Press, first ed. , 1979, second ed. , 1983).
See also the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, The Belmont
Report: Ethical Guidelines for the Protection of Human Subjects
of Research. DHEW Publication No. (OS) 78-0012 (1978), which
emphasizes principles of beneficence (includinq nonmalef icence
and utility) , justice, and respect for persons.
5. Kaufman, et al., "Kidney Donation: Needs and
Possibilities," p. 237.
6. Council on Scientific Affairs, "Organ Donor
Recruitment," p. 2158; Kenneth J. Bart, et al., "Increasing
the Supply of Cadaveric Kidneys for Transplantation,"
Transplantation 31 (1981): 383-87. Slightly different figures
are given in the two papers.
7. Bart, et al., "Increasing the Supply of Cadaveric
Kidneys for Transplantation," p. 385.
8. For some of the debate, see Paul Ramsey, The Patient
as Person (New Haven: Yale University Press, 1970) , chap. 5 ,
which argues that a policy of organized giving and receiving
is better than a policy of taking, and James Muyskens "An Alternative
Policy for Obtaining Cadaver Organs for Transplantation,"
Philosophy and Public Affairs 8 (1978) : 88-99. There is also
vigorous debate in the United Kingdom. See Ian Kennedy, "The
Donation and Transplantation of Kidneys: Should the Law Be
Changed?", Robert A. Sells, "Let's Not Opt Out: Kidney Donation
and Transplantation," and Ian Kennedy, "Kidney Transplants: A
Reply to Sells," Journal of Medical Ethics 5 (1979) : 13-21 and
165-69; 6 (1980) : 29-32.
9. Stuart, Veith, and Cranford, "Brain Death Laws...."
p. 238.
10. Ibid. , p. 239
11. Ibid.
370
12. McFall v. Shimp, Allegheny County Ct. Common Pleas,
10 Pa. D & C 3d 90. Excerpts appear in Michael H. Shapiro
and Roy G. Spece, Jr., Bioethics and Law: Cases, Materials
and Problems (St. Paul, Minn.: West Publishing Co., 1981),
pp. 819-20.
13. See Kaufman, et al., "Kidney Donation: Needs and
Possibilities," p. 238 (plus references). For some discussion
of the issues, see R. L. Lawton, "Living Nonrelated Donors for
Transplantation," Proc. Dialysis Transplant Forum (1978): 30-34;
L. Kamstra-Hennen and R. G. Simmons, "Ethics of Related Donation:
The Unsuccessful Case," Proc. Dialysis Transplant Forum (1978):
25-29; Carl H. Fellner and Shalmom H. Schwartz, "Altruism in
Disrepute: Medical versus Public Attitudes toward the Living
Organ Donor," New England Journal of Medicine 284 (March 18,
1971): 582-85.
14. Dorothy M. Bernstein, "The Organ Donor," Journal of
the American Medical Association 237 (June 13, 1977) : 2643.
15. Ibid.
16. Kaufman, et al., "Kidney Donation: Needs and
Possibilities," p. 238.
17. Carl H. Fellner and John R. Marshall, "Kidney Donors:
The Myth of Informed Consent," Amer. J. Psychiat. 126
(March 1970) : 1245-51, and Robert M. Eisendrath, Ronald D.
Guttmann, and Joseph E. Murray, "Psychologic Considerations in
the Selection of Kidney Transplant Donors," Surgery, Gynecology
and Obstetrics 129 (August 1969): 243-48.
18. Bernstein, "The Organ Donor," p. 2644.
19. For some of the issues, see Paul Ramsey, The Patient
as Person; Norman Fost, "Children as Renal Donors," New England
Journal of Medicine 296 (Feb. 17, 1977): 363-67; Norman K.
Hollenberg, "Altruism and Coercion: Should Children Serve as
Renal Donors?" New England Journal of Medicine 296 (Feb. 17,
1977) : 390-91; John A. Robertson, "Organ Donations by
Incompetents and the Substituted Judgment Doctrine," Columbia
Law Review 76 (1976): 48-78; Dorothy M. Bernstein and Roberta
G. Simmons, "The Adolescent Kidney Donor: The Right to Give,"
Am. J. Psychiatry 131 (December 1974): 1338-43.
20. "Live unrelated donors are generally not considered,
although there is a minority opinion about this subject, even
when children may be involved." Kaufman, et al., "Kidney Donation:
Needs and Possibilities," p. 238, For a minority opinion, see
Lawton, "Living Nonrelated Donors for Transplantation,"
21. Fellner and Schwartz, "Medical versus Public Attitudes
toward the Living Donor," p. 583.
22. See Jim Brooke, "Kidney, Cornea Sale Flourishes in
Brazil," Washington Post 10/12/81; Stuart, Veith, and Cranford,
"Brain Death Laws...." p. 241; Shapiro and Spece, Bioethics and
Law, pp. 823-28; Marvin Brams, "Transplantable Human Organs:
Should Their Sale Be Authorized by State Statutes?" American
Journal of Law and Medicine 3 (1977): 183-195; Clifton Perry,
"Human Organs and the Open Market," Ethics 91 (October 1980):
6 3-71; and Ramsey, The Patient as Person. Ramsey opposes the
sale of organs, while Brams and Perry argue for policies and
laws authorizing such sales.
23. Richard Titmuss, The Gift Relationship (New York:
Pantheon, 1971) .
371
Mr. Gore. Thank you very much. I find your testimony really
very helpful and thought provoking.
You two disagreed on the opting out system. In other words, we
now have the system where you can choose to be an organ donor
and if you don't make a choice, then it is assumed that you are not
an organ donor.
There have been two proposals, among others. One is to set up a
system that confronts everyone with the necessity of choosing yes
or no without any coercion to make one choice or another, leaving
aside the question of whether or not there is a subtle coercion at-
tached to the forcing of the question.
I take it that both of you would think that system passes ethical
muster. Is that correct? Dr. Veatch?
Dr. Veatch. I am not sure the extent to which we disagree.
Mr. Gore. I am going to get to the other scenario after this one.
This is the forcing of the choice. Dr. Childress went even further
and endorsed an opting out system, but let me hold that one up.
Dr. Veatch. I would favor forcing a response.
Mr. Gore. Forcing a response.
Dr. Veatch. I think a yes-no forced choice may be more than
people are prepared to make at this time. Yes, no and undecided
would be satisfactory. I would like to see that on our income tax
forms, or whatever we distribute regularly and store information
in a computerized fashion.
Mr. Gore. We might have to investigate what effect that might
have on tax evasion. [Laughter.]
Dr. Childress goes even further and says that in his view, it
would be ethically permissible to assume that people would wish
their organs donated absent an affirmative decision to say no.
You have a real problem with that, right, Dr. Veatch?
Dr. Veatch. I think there are real problems with that. Again, I
was attempting to summarize the positions taken by the major
churches and major theologians working with the churches.
There has been historically a problem with the salvaging or
opting out schemes. For example, we have a history, in some of the
earlier cases, of organs being taken without familial or patient con-
sent and then discovering only too late that there were family
members available who would have objected. I think the opting out
scheme creates an incentive for the system to fail to get donations
recorded efficiently, seek out relatives when there is no indication
of a donation.
I would prefer to maintain those incentives as long as possible to
make the donation system work. Only if we discover that the dona-
tion system and the forced choice systems didn't do the job should
we begin to consider ethics of the salvaging schemes. Quite frankly,
I see serious problems in them.
Mr. Gore. Dr. Childress?
Dr. Childress. I think Professor Veatch is right. We probably
don't disagree as much as it first appeared because we both agree
on the ranking of the systems, with the Uniform Anatomical Gift
Act at the top, as the preferable system; then a system of forced
decision, and then a system of presumed consent.
Where we differ I think is in our assessment of how soon, if ever,
we might need to move away from the Uniform Anatomical Gift
372
Act to one of the other systems. It may in part have to do with a
judgment about need and a judgment about effectiveness.
I think we do perhaps disagree at one point, though. I understood
Professor Veatch to suggest that the religious traditions have more
unanimity or uniformity of disagreement with a policy of presumed
consent than I think is actually the case.
I do not have a record of the opposition in the countries men-
tioned, but I think it is interesting to note that Israel is among the
countries with a system of presumed consent, along with a number
of other countries that pay a fair amount of attention to religious
values.
It may well be that Professor Veatch is reflecting the individual-
ism of most writers in the United States who work within theologi-
cal contexts. It is the case that no English-speaking country, to my
knowledge, has adopted presumed consent; this may reflect the tra-
dition of individualism more than the religious traditions to which
he referred.
Mr. Gore. We were unable to locate any data showing the suc-
cess of organ donation in countries with presumed consent systems.
You know of no such data, do you?
Dr. Childress. There is some information.
Mr. Gore. Would you provide that to the subcommittee? We
have conducted a rather thorough search. There is some sketchy
data, but we would like to have your thoughts on that as well.
Dr. Childress. It is not wholly adequate, but I would be glad to.
[The information follows:]
Without providing the statistics, one study notes that "countries with presumed
consent seem to come closer to meeting their needs for transplant kidneys." (Frank
P. Stuart, Frank J. Veith, and Ronald E. Cranford, "Brain Death Laws and Patterns
of Consent to Remove Organs for Transplantation from Cadavers in the United
States and 28 Other Countries," Transplantation 31 (1981): 239).
Mr. Gore. I will now recognize Congressman Reid.
Mr. Reid. Mr. Chairman, I have no questions. Thank you.
Mr. Gore. Dr. Veatch, in this week's issue of the Journal of the
American Medical Association you made some very interesting re-
marks.
One was, "If children are receiving or not receiving liver trans-
plants because of funding allocation decisions, then that is the kind
of insurance debate that the public ought to know about and par-
ticipate in."
Could you elaborate on this for us?
Dr. Veatch. I am concerned — and I think we have seen evidence
of it in the Fiskes' comments — that rather subtle, behind the
scenes judgments, either by government insurers or more often by
private insurers, in effect determine whether or not a life-saving
transplant takes place.
I would concur with Alex Capron in acknowledging that there
are some services that simply cannot be included in insurance
schemes, whether they be public or private. The decision to include
or exclude it seems to me must meet two criteria:
First, it must meet the criteria of fairness. If some people are in-
cluded, all people equally in need ought to be included as well.
Second, it has to meet what in the jargon of philosophy might be
referred to as the criterion of publicity. The public needs to partici-
373
pate actively in the judgment. We need to ask ourselves as a soci-
ety, do we want an insurance scheme that will cover liver trans-
plants or kidney transplants. As a collectivity, we should under-
stand that it is going to cost money for that insurance scheme if we
cover those services, just the way dialysis costs the government
money.
Mr. Gore. That is unclear in this case, however. We ought to
eliminate the disagreements over that because the evidence indi-
cates in some cases it is actually cheaper
Dr. Veatch. If it turns out to be cost effective to cover a medical
service, then it is common sense. By every criterion you could
imagine you would cover it.
The interesting cases are those where a service will be beneficial,
often only marginally beneficially, add months to a life or add a
year or two to life with suffering, perhaps, but at substantial cost.
For that kind of a question, it seems to me that, rather than in-
surance company bureaucrats or even those within the bowels of
HHS making decisions about medicare-medicaid funding, the
public as a whole needs to participate fully and actively and decide
what gets covered. Once the decision is made, either everyone gets
covered or no one gets covered.
Mr. Gore. Dr. Childress, you recommended a legal prohibition on
the sale of organs and body parts. You don't think that there is a
sufficient record of such practices to warrant legislative action at
this time, do you?
Dr. Childress. I have no evidence to suggest that there is. I
think in a way this would be a preemptive action to avoid some
problems down the road, in part because of the increased publicity
about the need for organs.
We have encountered some proposals for the sale of organs from
philosophers and lawyers and others — sometimes not only tongue
in cheek — and perhaps it would be wise to avoid some of the prob-
lems before they really become serious, again, in view of the in-
creased publicity about the need for organs.
Mr. Gore. I understand the State of Georgia has already passed
such a law. We will take that recommendation under considera-
tion. I have found that my colleagues and I are becoming increas-
ingly skeptical of preemptive laws. Your arguments are well put,
and we will certainly take them under consideration when we go
through our recommendations.
Let me thank the two of you for coming here. I always find the
testimony of bioethicists fascinating and enlightening. I congratu-
late you on the work that you do. I have been convinced for some
time, and even more so as chairman of this subcommittee, that the
debate over bioethics is going to become a routine dialog in this
country as new medical and biomedical techniques force choices
upon us that are simply unfamiliar to us.
Our traditional legal and ethical systems don't equip us to make
wise choices with respect to these new powers technology has con-
ferred upon mankind. As a result, the relatively new discipline of
bioethics has to scramble to keep up. We turn to it often for advice.
We appreciate your pioneering work in this area.
Thank you very much.
374
The final panel will speak to us about the legal considerations
involved in this area. We are pleased and honored to have Dr.
David Wiecking, Office of the Chief Medical Examiner in Rich-
mond, Va.; Dr. Roger Evans, research scientist with the Health and
Population Study Center at the Battelle Institute in Seattle; and
John McCabe, legal counsel with the National Conference of Com-
missioners on Uniform State Laws, from Chicago.
Dr. Wiecking, we will begin the panel with you. We are delighted
to have you here. Without objection, the entire text of your re-
marks will be included in full in the record. We invite you to
present that portion of it as you see fit. Welcome.
STATEMENTS OF DAVID WIECKING, M.D., OFFICE OF THE CHIEF
MEDICAL EXAMINER, RICHMOND, VA.; DR. ROGER W. EVANS,
RESEARCH SCIENTIST, HEALTH AND POPULATION STUDY
CENTER, BATTELLE INSTITUTE, SEATTLE, WASH.; AND JOHN
McCABE, LEGAL COUNSEL, NATIONAL CONFERENCE OF COM-
MISSIONERS ON UNIFORM STATE LAWS, CHICAGO, ILL.
Dr. Wiecking. Thank you, Mr. Chairman, gentlemen.
The medical examiners in this country are the physicians, many
of them pathologists, who investigate violent, sudden, and unex-
pected deaths. Each year in this country there are about 25,000
homicide victims, 28,000 suicides, and 100,000 accidental deaths,
50,000 from automobile fatalities.
Many of these victims of sudden death are otherwise healthy
young adults who would be excellent organ donors. Unfortunately,
many of these organs are not utilized for that purpose. It would be
an excellent idea if there were some system which would permit
the orderly and expeditious use of transplantable organs from
those victims.
The common law of dead bodies in the Anglo-American jurisdic-
tions indicates that the dead body is the property of the next of kin
for purposes of a decent disposition. Therefore, we must obtain per-
mission from the next of kin for an organ harvest. The only signifi-
cant change in this has been the Uniform Anatomical Gift Act,
which has already been mentioned this morning.
Some States put donor forms on the back of the driver's license.
In theory, it is a good idea. In practice, it often is not found until
too late.
Another problem which occasionally occurs from the medical ex-
aminer's standpoint is that of releasing a donated organ from a
medical examiner's case even with the express approval of the de-
cedent or his next of kin.
Of course, from the medical-legal standpoint, it is important that
the medical examiner be permitted to perform his statutory duty of
determining the cause and manner of death without interference.
The usual problem, however, comes up where an organ is sought
from a part of the body removed from the area of injury. This, in
my opinion, should not present any insuperable problem to the
medical examiner.
For instance, there is no reason, in my opinion, why a medical
examiner should be reluctant to release a kidney for transplant
from the body of a person who has been shot in the head. Occasion-
375
ally, it is feared that some astute defense attorney will capitalize
upon this. I don't think that is a viable objection.
Some States, as we have already heard, have enacted legislation
which will permit the medical examiner to take organs from a
case, presuming in law that the person has consented to the taking
of the organs, subject to the express disapproval of the surviving
next of kin; the opting in system, as I understand it.
This, obviously, would work to the increased number of organs,
but it has been opposed by certain people from religious and liber-
tarian viewpoints. I doubt that the majority of Americans would
object to an opting in system, and I think it would be a very useful
mechanism.
The only request from the medical examiner is that the medical
examiner be notified promptly and without equivocation as to
whether this person has or has not previously objected to the pro-
posed taking of the organ.
Medical examiners in this country have jurisdiction over dead
bodies pursuant, in the great majority of cases, to State law. The
Federal Government has very limited jurisdiction over death and
very few facilities to deal with it. How the Federal Government
will affect the organ harvest situation is obviously the purpose of
these hearings.
It would appear to me that it must come through encouragement
to the States to change State jurisdictional statutes to give the
medical examiners the power to obtain these organs when they are
sought.
In my opinion, the vast majority — and I would hope all — of the
medical examiners in this country cooperate with organ procure-
ment programs and cooperate with transplant surgeons when they
are requested. It does not mean increasing the number of autop-
sies. It does not mean changing the criteria for performance of a
medical-legal autopsy. It means merely saving an otherwise dis-
carded organ to be used to prolong the life of a living person.
The medical examiners in this country are ready to help. What
we need is the statutory immunity and the statutory authority to
do so.
Thank you.
Mr. Gore. Thank you very much.
[The prepared statement of Dr. Wiecking follows:]
Statement of Dr. David K. Wiecking, Chief Medical Examiner for the
Commonwealth of Virginia
I am Dr. David K. Wiecking of Richmond, Virginia. I am Chief Medical Examiner
for the Commonwealth of Virginia and Chairman of the Board of Directors and im-
mediate Past President of the National Assocation of Medical Examiners. The Medi-
cal Examiners in this country are the physicians, many of them pathologists, who
perform the medico-legal investigations into violent and suspicious death cases.
Each year in this country there are approximately 25,000 homicide victims, 28,000
suicides, and 100,000 accidental deaths, including about 50,000 automobile fatalities.
Many of these victims of sudden death are otherwise healthy young adults who
would be excellent organ donors for transplant purposes. Unfortunately however
from the transplant surgeon's standpoint and even more importantly from the per-
spective of the patient awaiting the transplanted organ, very few of the transplant-
able organs from the suddent death victims can be utilized under the present state
of the common and statutory law. It would be a tremendous benefit to the numbers
and the success of transplant operations if the transplantable organs from the
sudden death victims could be utilized in a systematic and expeditious method.
376
The common law of dead bodies in the Anglo-American jurisdictions indicates
that the body of the deceased is the property of the next-of-kin for purposes of a
decent disposition. The common law states that permission from the next-of-kin
must be obtained in order for any portions of the dead body to be utilized for any
other purpose. This notification and receipt of permission requirement causes fre-
quent problems of time delay which render the sought-after organ useless for trans-
plant. The only significant change in this common law requirement had been the
introduction of state legislation of the Uniform Anatomical lift Act, which gives
the donor the power to direct diposition of his organs when he dies. The Uniform
Anatomical Gift Act has been a significant help, but there are still many potential
donors who have not completed donated forms, and others wherein the donation
form is not discovered until too late. Some States have put the donor forms on the
back of the driver's license, and while that again theoretically is a good idea it does
not work too well in practice because too often the driver's license of the deceased is
not examined or it is examined too late.
Another problem which occasionally occurs is the reluctance of the Coroner or
Medical Examiner to release a donated organ even with the express approval of the
decedent's next-of-kin. From the medico-legal standpoint, it is of course paramount
that the Medical Examiner or Coronor be permitted to perform his principal
medico-legal objective, which is the accurate and legally defensible determination of
the cause and manner of death. Removal of an organ for transplant which interfers
with the Medical Examiner's statutory duty is not appropriate. The usual situation
however is that the Medical Examiner is concerned about the injured organs and
the recovery of bullets and other items of evidence related to the death. The remov-
al of a useful organ for transplant remote from the area of bodily injury and which
does not impair the recovery of evidence from the body should not present an insu-
perable problem for the Medical Examiner. The transplant surgeon will not want an
organ which has been injured, and the transplant surgeon can always attest to the
normality of any organ which he has removed and transplanted. The occasionally
voiced fear that an astute defense attorney will impeach the Medical Examiners'
testimony because for example, the kidneys have been removed for transplant from
a gunshot wound to the head case, is not a valid objection to the beneficial purposes
of organ transplant.
Some States have enacted legislation permitting the Medical Examiner to take
organs from the deceased upon the request of a transplant surgeon, presuming in
law that the deceased and his family would approve, subject to express disapproval
by the surviving kin. Such a statutory presumption certainly works to the increased
efficiency of organ procurement and it probably represents the sentiments of the
great majority of citizens. There are however opponents of such a presumption of
approval, based on religious and libertarian viewpoints. It is a philosophical ques-
tion which must be resolved in a rational manner for the betterment of our society
as a whole. It is doubtful that the majority of Americans would object to the remov-
al of a viable kidney from a suddenly deceased relative which can be used to pro-
long the life of another person. It would seem in the public interest to assume that
such a donation is desirable and to put the burden of objecting to it upon the objec-
tor.
Medical Examiners and Coronors assume jurisdiction over dead bodies pursuant
in the great majority of cases to state and local statutory law. The Federal govern-
ment has very limited jurisdiction over sudden or violent death cases, and has very
few facilities to deal with them on a routine basis. How the Federal government
would implement procedures to expedite organ procurement from such cases is evi-
dently the purpose of these hearings. It would seem that it must be done through
encouragement to the States to enact enabling legislation to permit Medical Exam-
iners and Coroners to obtain transplantable organs during the course of their rou-
tine statutorily authorized medico-legal autopsies. In my opinion the great majority
of Medical Examiners and Coroners in this country would be cooperative with organ
procurement and transplant operators provided they had the statutory immunity
and authority to harvest the transplantable organs. It does not mean increasing the
number of autopsies, nor changing the criteria for performance of a medico-legal au-
topsy, but merely the saving of an otherwise discarded organ to be used to prolong
the life of a living person. The Medical Examiners of this country are ready to help;
what they need is the statutory authority.
Mr. Gore. We would like to hear now from Dr. Roger Evans, the
research scientist at the Health and Population Study Center at
the Battelle Institute in Seattle. We appreciate your willingness to
testify today instead of yesterday, Dr. Evans. Please proceed.
377
Dr. Evans. Thank you very much, Mr. Chairman.
I am very pleased to have the opportunity to testify. Under my
direction at the Human Affairs Research Centers in Seattle, we are
currently engaged in two major studies concerning organ trans-
plantation. These are the national heart transplantation study and
the national kidney dialysis and kidney transplantation study.
Both studies are sponsored by the Health Care Financing Adminis-
tration.
In developing a prototypical approach to the assessment of
health care technology, the national heart transplantation study is
addressing numerous issues we have discussed over the past 2 days.
These include the need for heart transplantation in the United
States; the availability of donor hearts; the survival of heart trans-
plant recipients; the cost of performing a heart transplant and pro-
viding the routine care required thereafter; the quality of life and
rehabilitation enjoyed by heart transplant recipients; the legal and
ethical issues pertaining to the selection of candidates, the procure-
ment of organs, and the conduct of heart transplantation proce-
dures.
The major objective of the study, once the foregoing analyses are
completed, is to examine the impact of a potential coverage deci-
sion on the medicare program, transplant beneficiaries, and health
care providers.
I might add that we could insert liver transplantation through-
out. That is what I am trying to refer to by prototypical approach,
that the issues that we are addressing in the heart transplant
study are really generic to many health care technologies that
have emerged today or have existed for some time.
For purposes of today's testimony, you are undoubtedly most in-
terested in that component of the national heart transplantation
study concerning donor organ procurement. First, let me describe
each of several data collection efforts we plan to undertake. Having
done this, I would then like to present some results from an infor-
mal inquiry we have just completed concerning the status of organ
procurement with regard to the Uniform Anatomical Gift Act,
brain death laws and organ retrieval procedures throughout the
United States.
We have now planned and are about to carry out three separate
data collection activities on both potential and actual donors. The
first of these activities amounts to an analysis of existing data in
an attempt to estimate the total number of people who die in hos-
pitals each year who satisfy various donor selection criteria and
thus are potential organ donors.
Eligible donors, as we have now heard, must be brain dead. It
has been estimated that as many as 20,000 people die each year in
the United States who have brain injury, tumor, or infarction, all
of which may make them reasonable donor candidates.
To provide a more realistic estimate of the availability of donor
hearts, we plan to modify the estimates derived through the above
analyses based upon information we obtain in a second data collec-
tion effort; that being the potential organ donor survey.
You may be aware that in 1968 a Gallup poll indicated that 70
percent of Americans expressed their willingness to donate organs
for transplantation at the time of their death. We heard yesterday
378
and again today that the number has seemed to decline substan-
tially since 1968 in the recent National Kidney Foundation poll.
This may be a source of some concern, given the proceedings of this
meeting.
In our survey, to be undertaken within the next several months,
we plan to determine not only people's willingness to donate
hearts, but also their willingness to donate kidneys, corneas, livers,
lungs, pancreas, the skin, and bodies.
As you may be aware, people discriminate in terms of which
organ they will donate. Some people are willing to donate kidneys
but are unwilling to donate hearts and corneas, for example, so it
is important to document each of these.
Data will also be obtained on age, sex, and various other social
and demographic characteristics of the respondents. There are var-
ious characteristics that respondents have that exclude them as
being potential donors, age being one of the foremost.
Respondents will be asked to answer questions regarding brain
death and their willingness to permit organs to be removed from
their spouse or children if, upon the declaration of brain death of
the latter, they are found not to be carrying donor cards.
Finally, we plan to initiate an intense 12-month survey of nearly
all organ procurement programs in the United States. The purpose
of this survey is to determine how many actual kidney donors
could have also been heart donors.
To better characterize the current state of organ procurement in
the United States. I would like to take a few minutes to describe
the results of a recent inquiry my associates and I have completed.
We were interested in finding out some of the reasons for the con-
tinuing disparity between the supply and the demand for donor
organs.
The interview guide we used focused on the following areas:
State laws enacted, donor documentation, education and participa-
tion of public hospital personnel and law enforcement personnel,
and consent required from decedent's next of kin.
Our inquiry found that all 50 States and the District of Columbia
have adopted some form of the Uniform Anatomical Gift Act. We
found that the majority of the larger organ procurement programs
were well aware of the provisions of the act. However, some re-
spondents were unaware of particular variations and a few were
unaware of the provisions of the act. In addition, many people ex-
pressed misinterpretations of key provisions of the act.
DETERMINATION OF DEATH
We, specifically, asked people about their State statutes that de-
lineate a definition of death. We found that although only 30
States have a legislatively determined definition of death, 48 used
brain death as a standard for death in appropriate cases.
Whether legally stated or not, the decision to declare death is
left to the physician, based on common law and the use of medical-
ly acceptable criteria. In these States, the medical community has
set forth the criteria that gives structure, consistency, and confir-
mation to the determination of death.
379
The concept of brain death, at least in the medical profession, ap-
pears to be widely accepted. Thus, legislative recognition of the
brain death standard does not appear to substantially affect the
harvesting of organs for transplantation.
DOCUMENTATION
The documentation required to indicate a person's wish to donate
his or her organs varies from State to State. Of primary interest
were documents that potential donors might carry with them;
namely, drivers' licenses and organ donor cards.
Forty-four States have a provision on their permanent drivers' li-
censes for organ donation. These provisions are optional, meaning
that the driver has the option of stating his or her intentions re-
garding organ donation. A variety of methods are used to identify
potential donors on licenses.
No State requires drivers to indicate whether or not they are
willing to donate organs. This is contrary to what was stated yes-
terday. The State of Colorado, in checking with the attorney gener-
al's office, does not require a person check the yes or no box.
At best, drivers are presented with the option of stating their in-
tentions. In Colorado, where the donor box appears on the face of
the license, response has been impressive. Out of 1.5 million driv-
ers, 900,000, that is 60 percent, are designated as donors.
Other States that place organ donation provisions on the faces of
their drivers' licenses report fewer designated donors, between 1.5
percent and 8.5 percent. I believe that the discrepancy with regard
to Colorado may be a result of misinterpretation. People simply
feel they must check the box, although we can't be certain at this
time.
Another document that may be used to identify potential donors
is the organ donor card. These cards are generally distributed inde-
pendently of the drivers' licenses by an organization within the
State, such as the National Kidney Foundation or the Lion's Eye
Bank. This form of documentation is available in all but three
States.
Although the people we talked with could not provide exact fig-
ures, they repeatedly emphasized the fact that the percentage of
donors with cards is very small. One transplant coordinator esti-
mated that the number of card-carrying donors is 2 or 3 percent of
all donors at most. Another person reported that out of 600 donors
in the past 7 years, only 3 had carried donor cards.
If only such a small percentage of donors actually have cards,
then what role do donor cards play? Leverage, said many people we
talked to. When approaching the family, medical personnel and
transplant coordinators use the card as evidence of the decedent's
wish to donate his or her organs. It is also used as an educational
tool, a symbol to promote awareness and discussion of organ dona-
tion, especially among families.
When asked how it is determined if a potential organ donor is
carrying a card, we found no State had a comprehensive procedure
to be followed by law enforcement and medical personnel who
might be involved with accident victims. Only one State reported
that its State police department had an official policy directing its
380
force to look for donor cards at the scene of accident and to alert
hospital personnel if one was found.
When we asked what action medical personnel would take to
identify a potential donor, the people we talked to gave a variety of
responses. The organ-procurement agencies in a few States have es-
tablished ties with at least one intensive care unit nurse in almost
every hospital who acts as an organ retrieval coordinator. The
nurse/coordinator monitors the course of every patient in the unit.
When a patient's condition is clearly terminal, the nurse ar-
ranges with the attending physician to have one of them talk with
the family about organ donation, after the family has been in-
formed of their relative's prognosis. With this system, almost every
potential donor is identified and his or her family approached con-
cerning organ donation.
Consent. Perhaps the most crucial step in the entire organ dona-
tion procedure is obtaining consent from the next of kin. If donor
documents are not available — and the percentage of donors with
cards is negligible — the Uniform Act authorizes survivors to make
anatomical gifts of all or part of the decedent's body, unless they
are aware of contrary intentions by the decedent.
The first consent question we asked was, "If a card is not found,
would next of kin be consulted concerning organ donation?" People
we talked to in 45 States answered yes. This may be the case in
four other States, but not necessarily. Transplant coordinators ex-
plained that it depends strictly on the attending physician. In the
remaining two States, the issue of organ donation is never raised
with survivors because there are no organ procurement programs
in the States.
We also asked who approached the decedent's family concerning
anatomical gifts. In some institutions, this responsibility lies with
one person or department exclusively. Generally speaking, howev-
er, the people we talked to named more than one source.
Section 2(e) of the Uniform Anatomical Gift Act states, "The
rights of the donee created by the gift are paramount to the rights
of others except as provided by Section 7(d) (medical examiners'
duties)." Given proper documentation, such as a signed donor card
or marked driver's license, physicians may legally remove organs
from decedents even if families object. The results of our inquiry,
however, indicate that this rarely happens.
With donor documentation available, family consent is still re-
quired in the vast majority of States. People we talked to in 47
States said that surgeons require family approval. When presented
with the hypothetical situation in which the decedent's relatives
could not be located, only 11 of the 47 States said they would prob-
ably proceed with organ removal.
Three major reasons were given for requiring family consent de-
spite valid donor documentation. In 28 States, people said they rely
on family confirmation in order to avoid potential legal disputes.
Ethical considerations are another major reason that next of kin
consent is required. It is a factor in 25 States where medical per-
sonnel feel that it is morally wrong to ignore objections raised by
survivors.
Finally, 15 States cited fear of bad publicity as a reason for ob-
taining family consent for organ removal.
381
Only four States take full advantage of the provisions of their
anatomical gift acts. Transplant coordinators in these states ex-
plained that potential donor intentions, legally documented, cannot
be vetoed by others. The family is simply informed of the proce-
dure as a matter of formality. The results of the inquiry reported
here suggest several areas which should be further addressed in
the future.
Clearly there are a number of important issues concerning the
impact of laws pertaining to anatomical gifts. It is evident that the
original goal of the measure has not been achieved; that is, the
Uniform Anatomical Gift Act alone has not succeeded in more
closely matching supply to demand. Anatomical gift laws have
been enacted, brain death laws passed, documents distributed and
medical personnel educated, but the demand still far exceeds the
supply.
There is little doubt that a greater number of signed donor cards
would be likely to increase the supply of donor organs. Transplant
coordinators across the country emphasized that very few families
withhold consent when made aware of the decedent's donor docu-
mentation.
The fact that only a small percentage of donors actually have
donor cards raises questions about current methods of document
distribution. The work of private groups or institutions is limited
by their own resources and, at best, they can only ask the people
they reach to consider their cause.
There are certainly things that can be done to increase card dis-
tribution, such as making cards available in more hospitals, doc-
tors' offices and schools, but these efforts cannot reach all groups
or individuals in the public sector. In contrast, the government not
only has the greatest access to the public, but also has the capabili-
ty of devoting substantial monetary resources to the task of pro-
moting organ donation.
Should the government play a more aggressive role in promoting
organ donation? Should it assume the responsibility of at least pre-
senting the issue to every adult. Every state could do more to
insure that the organ donor section on the driver's license is more
than a box that one probably ignores or forgets to fill in.
People we talked to indicated that the greatest difference among
programs and hospitals is not in how they identify donors but
rather how consistently they attempt to do it. Building a network
of involved, motivated referral sources among medical personnel
requires a great deal of effort, patience and farsightedness on the
part of organ procurement agencies.
The results of our inquiry also suggest that the Uniform Act is
largely ignored when it comes to matters of consent. Although the
Act recognizes donor documents as sufficient evidence of the dece-
dent's intentions and even extends blanket protection to physicians
who remove organs while acting in good faith, the vast majority of
medical institutions in this country will not allow organ removal
without consent from the next of kin.
Thus, while the philosophy of the act is to carry out the dece-
dent s wish, the reality is that these wishes cannot be carried out
until the family approves. Most institutions base this policy on
23-029 0-83-25
382
their fear of prosecution, a definite sign that they feel the protec-
tion offered them in the Uniform Act is not sufficient.
Legislation may or may not remove all perceived barriers to ef-
fective organ procurement. There remains the question of how to
deal with ethical objections and the fear of bad publicity. Again, an
important key to the answer is education, both professional and
public. Organ donation must be presented in a positive light. If the
attitudes of medical personnel and the general public reflected
these positive aspects of organ donation, ethica1. objections and the
fear of legal liability and bad publicity would not be seen as such
serious obstacles.
I would like to conclude my testimony with some comments on
the National Kidney Dialysis and Kidney Transplantation Study.
This study is concerned with the costs and benefits associated with
various approaches to the treatment of kidney failure, often re-
ferred to as end-stage renal disease. The purpose of the study is to
identify which of several treatment modalities is least costly to the
Federal Government yet, at the same time, is most beneficial to the
patients being treated.
I think, at the outset, that we would all agree that cost should
not be the sole criterion upon which we base our judgment of the
effectiveness of alternative treatments. Yet, at the same time, we
recognize that cost is a very important consideration. This has been
emphasized repeatedly over the past 2 days.
It is in this regard that kidney dialysis and transplantation raise
some very difficult questions which we must confront as a society.
As we now see, these questions have to do with what we might call
resource allocation and rationing.
I have thoroughly considered these issues in two papers which
will appear in the April 15 and April 22 issues of the Journal of
the American Medical Association. That paper is part of my writ-
ten testimony.
In my estimation, we have now reached a point where there is
what I might call a new medical imperative, that being to develop
policies and procedures for making resource allocation and ration-
ing decisions. These decisions, I might add, cannot be left solely to
physicians; that is, it requires a great deal of involvement on
behalf of governmental agencies and personnel.
In 1982 it cost approximately $1.8 billion to treat about 65,000
patients with kidney failure in the United States. This is up from
$747 million in 1978. While the actual cost per patient per year for
treating end-stage renal disease has decreased when adjusted for
the rate of inflation, rising total program costs have led to a recon-
sideration of the future viability of the end-stage renal disease pro-
gram.
Policymakers are also concerned that the outcomes experienced
by many patients are unsatisfactory, thus raising questions about
the overall benefits of the program as well.
A most difficult question is now being asked. Are ESRD pa-
tients— that is, people who have kidney failure — truly benefiting
from long-term maintenance dialysis and kidney transplantation?
Recently, several studies have shown that the benefits derived by
many patients are relatively few. Indeed, many patients appear to
lead unacceptable lives, characterized by frequent hospitalization,
383
family discord, and personal catastrophe. Thus, while it cannot be
denied that the ESRD program has saved lives of patients with
chronic renal failure, attention is now beginning to focus on the
quality of their lives.
In the National Kidney Dialysis and Kidney Transplantation
btudy, the quality of life of 859 patients randomly selected from 11
dialysis and transplant centers across the United States, has been
assessed. These results show clearly that kidney transplantation
when successful, is a superior treatment alternative to long-term
maintenance dialysis of any kind.
At the same time, however, it is evident from our results that
patients who have experienced a failed kidney transplant have sig-
nificant medical and rehabilitation problems which distinguish
them from successful kidney transplant recipients.
Thus, rather than use the results of this study to promote kidney
transplantation as optimal treatment modality for end-stage renal
disease, I remain committed to the position that dialysis and trans-
plantation must be viewed as complementary, rather than competi-
tive treatment modalities.
Over the past 2 days there has been considerable discussion of
the cost of organ transplantation. Moreover, I would like to under-
score the fact that the cost of dying with untreated catastrophic
disease is far less than providing even routine treatment for cata-
strophic disease; that is, if no attempt is made to reverse the dis-
ease process upon the diagnosis of a condition, such as biliary atre-
sia or idiopathic cardiomyopathy, dollars are in a sense saved. This
was pointed out yesterday by Dr. Starzl, when he was citing the
study which indicated that the cost of dying was quite expensive.
As a society, we obviously find it cruel to withhold even routine
treatment. This has been borne out over the past 2 days. Thus, the
C0/} j a transPlant procedure must be viewed as the marginal
added costs which are incurred over and above the routine medical
care that would have been provided regardless of whether or not
the patient in question received a transplant.
For example, a patient who does not receive a transplant will
incur considerable medical expenses, regardless of whether or not
they receive a transplant. We need to keep this in mind when we
consider cost. Despite this, however, we must recognize that there
are truly limits to how much we can realistically do to spare
human lives from that which is truly inevitable: death.
For example, is it a wise use of scarce resources to do everything
imaginable to maintain the life of a patient with a terminal cancer
whose prospects of living beyond a few months is virtually nil? Are
these resources not better spent in providing care to other patients
who are likely to benefit?
At the same time, we find it especially cruel when representa-
tives of major government insurance companies, such as medicare,
medicaid, and CHAMPUS, as well as private insurance companies,
such as Blue Cross and Blue Shield decide not to pay for proce-
dures such as heart and liver transplantation.
Yet, what we often fail to recognize is that these coverage deter-
minations, as I refer to them, are by no means simple. A consider-
able amount of data must be amassed and analyzed to better un-
derstand the implications— financial, legal, ethical, and sociomedi-
384
cal — of the decisions we make. This is precisely what we are doing
for the Federal Government in the Health Care Financing Admin-
istration-sponsored National Heart Transplantation Study.
Is it not unusual that at at time when we are considering the
possibility that the medicare program is likely to go broke we are
suggesting that coverage be extended to include very expensive life-
saving therapy, such as liver transplantation, which is estimated to
cost between $175,000 to $200,000 per procedure?
Is it net time that we begin to ask how many of these procedures
can be supported by public funds? I think the ethicists have made
this point.
With these remarks I do not intend to suggest that many of the
costly procedures we have discussed over the past 2 days are not
worthy of support. Indeed, they are. What I want to suggest is that
perhaps resource allocations to public health care programs do not
reflect the priority that the public attaches to them.
In effect, if the public only wants the finest health care availa-
ble, as was suggested yesterday, is it truly willing to pay for it? Do
current allocations to publicly subsidized health care programs re-
flect this public commitment? In effect, should more resources be
allocated to health care programs and less to alternative uses?
Ultimately we must recognize that the Brandon Halls and the
Jamie Fiskes really serve to epitomize a much larger problem we
must confront as a society. It clearly goes well beyond the organ
procurement problem itself.
There are many people in this world with a variety of medical
problems which can be treated if we are willing to expend the re-
quired resources, but since the necessary resources are truly finite,
we must make what some have referred to as tragic choices.
It is in making these decisions that we come to recognize that ill-
ness, despite its tragedy, is part of the human condition, and that
illness provides meeting and insight into the human condition.
Thank you.
[The prepared statement of Mr. Evans follows:]
385
ORAL TESTIMONY
Presented before the
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
of the
COMMITTEE ON
SCIENCE AND TECHNOLOGY
U. S. HOUSE OF REPRESENTATIVES
on
April 14, 1983
by
Roger W. Evans, Ph.D.
Research Scientist
Health and Population Study Center
Battelle Human Affairs Research Centers
4000 N.E. 41st Street
Seattle, Washington 98105
This testimony has been prepared by Roger W. Evans, Ph.D., Thomas D.
Overcast, J.D., Ph.D., Lisa E. Bowen, B.S., Marilyn M. Hoe, B.A.,
Cynthia A. Livak, B.A., Karen Merrikin, B.A., Louis P. Garrison, Ph.D.
and Diane L. Manninen, Ph.D.
386
Mr. Chairman and Members of the Subcommittee:
As a Research Scientist at the Battel 1e Human Affairs Research Centers
located in Seattle, Washington, I am pleased to testify today. Under my
direction, the Human Affairs Research Centers is currently engaged in two
major studies concerning organ transplantation. These are: the National
Heart Transplantation Study and the National Kidney Dialysis and Kidney
Transplantation Study. Both studies are sponsored by the Health Care
Financing Administration (HCFA).
In developing a prototypical approach to the assessment of health care
technology, the National Heart Transplantation Study is addressing numerous
issues including: the need for heart transplantation in the U.S., the
availability of donor hearts, the survival of heart transplant recipients,
the cost of performing a heart transplant and providing the routine care
required thereafter, the quality of life and rehabilitation enjoyed by heart
transplant recipients, the legal and ethical issues pertaining to the
selection of candidates, the procurement of organs, and the conduct of heart
transplantation procedures. The major objective of the study, once the
foregoing analyses are completed, is to examine the impact of a potential
coverage decision on the Medicare program, transplant beneficiaries, and
health care providers.
For purposes of today's testimony, you are undoubtedly most interested
in that component of the National Heart Transplantation Study concerning
donor organ procurement. First let me describe each of several data
collection efforts we plan to undertake. Having done this, I would then
like to present some results from an informal inquiry we have just completed
/
387
concerning the current status of organ procurement with regard to the
Uniform Anatomical Gift Act, brain death laws, and organ retrieval
procedures throughout the United States.
We have now planned and are about to carry out three separate data
collection and data analysis activities on both potential and actual organ
donors. The first of these activities amounts to an analysis of existing
data in an attempt to estimate the total number of people who die in
hospitals each year and who satisfy various donor selection criteria and,
thus, are potential organ donors. Eligible donors must be brain-dead. It
has been estimated that as many as 20,000 people die each year in the U.S.
who have brain injury, tumor, or infarction, all of which may make them
reasonable donor-candidates (Council on Scientific Affairs, 1981:2157).
To provide a more realistic estimate of the availability of donor
hearts, we plan to modify the estimates derived through the above analyses
based upon information we obtain in a second data collection effort, that
being, the Potential Organ Donor Survey. You may be aware that in 1968 a
Gallup poll indicated that 70.0 percent of Americans expressed their
willingness to donate organs for transplantation at the time of their death
(Council on Scientific Affairs, 1981). In our survey, to be undertaken
within the next several months, we plan to determine not only people's
willingness to donate hearts, but also their willingness to donate kidneys,
corneas, livers, lungs, pancreases, skin, and bodies. Data will also be
obtained on age, sex, and various other social and demographic
characteristics of the respondents. Finally, respondents will be asked to
answer questions regarding brain death and their willingness to permit
388
organs to be removed from their spouse or children if, upon the declaration
of brain death of the latter, they are found not to be carrying donor
cards.
Finally, we plan to initiate an intense 12-month survey of nearly all
organ procurement programs in the U.S. The purpose of this survey is to
determine how many actual kidney donors could also have been heart donors.
Now, to better characterize the current state of organ procurement in
the U.S., I would like to take a few minutes to describe the results of a
recent informal inquiry my associates and I have completed. We are
interested in finding out some of the reasons for the continuing disparity
between the supply of, and demand for, donor organs. The interview guide we
used focused on the following areas:
state laws enacted;
donor documentation;
education and participation of public, hospital personnel, and
law enforcement personnel;
consent required from decedent's next-of-kin.
In our inquiry we found that all 50 states and the District of Columbia
have adopted some form of the Uniform Anatomical Gift Act. We found that the
389
majority of the larger organ procurement programs were well aware of the
provisions of the Act, however some respondents were unaware of particular
variations and a few were unaware of the provisions of the Act. In addition,
many people expressed misinterpretations of key provisions of the Act.
Determination of Death
We specifically asked people about their state's statutes that delineate a
definition of death. We found that although only 30 states have a
legislatively determined definition of death, 48 (94%) use brain death as a
standard for death in appropriate cases. Whether legally stated or not,
the decision to declare death is left to the physician, based on common law
and the use of medically acceptable criteria. In these states, the medical
community has set the criteria that give structure, consistency, and
confirmation to the determination of death. The concept of brain death, at
least in the medical profession, appears to be widely accepted and, thus,
legislative recognition of the brain death standard does not appear to
substantially affect the harvesting of organs for transplantation.
Documentation
The documentation required to indicate a person's wish to donate his or
her organs varies from state to state. Of primary interest were documents
that potential donors might carry with them, namely drivers' licenses and
organ donor cards.
Forty-four states (86%) have a provision on their permanent drivers'
licenses for organ donation. These provisions are optional, meaning that the
driver has the option of stating his or her intentions regarding orqan
donation. A variety of methods are used to identify potential donors on
1 icenses:
390
No state requires drivers to indicate whether or not they want to donate
organs. At best, drivers are presented with the option of stating their
intentions. In one state3 where the donor box appears on the face of the
license, response has been impressive: out of 1-5 million drivers, 900,000
(60%) are designated as donors. Other states4 that place organ donation
provisions on the faces of their driver's licenses report fewer designated
donors, between 1.5% and 8.5%.
Another document that may be used to identify potential donors is the
organ donor card. These cards are generally distributed independently of the
drivers' licenses by an organization within the state, such as the National
Kidney Foundation or the Lion's Eye Bank. This form of documentation is
5
available in all but three states.
Although the people we talked with could not provide exact figures, they
repeatedly emphasized the fact that the percentage of donors with cards is
very small. One transplant coordinator estimated that the number of
card-carrying donors is two or three percent of all donors at most. Another
person reported that out of 600 donors in the past seven years, only three nad
carried donor cards.
If only such a small percentage of donors actually have cards, then what
role do donor cards play? Leverage, said many people we talked to. When
approaching the family, medical personnel and transplant coordinators use the
card as evidence of the decedent's wish to donate his or her organs. It is
also used as an educational tool, a symbol to promote awareness and discussion
of organ donation, especially among families.
391
Procedures
When asked how it is determined if a potential organ donor is carrying a
card, we found no state had a comprehensive procedure to be followed by law
enforcement and medical personnel who might be involved with accident
victims. Only one state reported that its state police department had an
official policy directing its force to look for donor cards at the scene of an
accident and to alert hospital personnel if one was found.
When we asked what action medical personnel would take to identify a
potential donor, the people we talked to gave a variety of responses. The
organ procurement agencies in a few states have established ties with at least
one intensive care unit nurse in almost every hospital who acts as an organ
retrieval coordinator. The nurse/coordinator monitors the course of every
patient in the unit. When a patient's condition is clearly terminal the nurse
arranges with the attending physician to have one of them talk with the family
about organ donation—after the family has been informed of their relative's
prognosis.
Consent
Perhaps the most crucial step in the entire organ donation procedure is
obtaining consent from the next-of-kin. If donor documents are not available,
the Uniform Act authorizes survivors to make anatomical gifts of all or part
of the decedent's body, unless they are aware of contrary intentions by the
decedent. The first consent question we asked was, "If a card is not found,
would next-of-kin be consulted concerning organ donation?" People we talked
to in 45 states (88%) answered yes. This may be the case in four other
states, but not necessarily; transplant coordinators explained that it
392
D
depends strictly on the attending physician. In the remaining two states,
the issue of organ donation is never raised with survivors because there are
no organ procurement programs in the states.
We also asked who approached the decedent's family concerning anatomical
gifts. In some institutions, this responsibility lies with one person or
department exclusively. Generally speaking, however, the people we talked to
named more than one source.
Section 2E of the Uniform Anatomical Gift Act states, "The rights of the
donee created by the gift are paramount to the rights of others except as
provided by Section 7(d) (medical examiners' duties)." Given proper
documentation, such as a signed donor card or marked driver's license,
physicians may legally remove organs from decedents even if families object.
The results of our inquiry, however, indicate that this rarely happens. With
donor documentation available, family consent is still required in the vast
majority of states. People we talked to in 47 states9 (92%) said that
surgeons require family approval. When presented with the hypothetical
situation in which the decedent's relatives could not be located, only 11 of
the 47 states10 said they would probably proceed with organ removal.
Three major reasons were given for requiring family consent despite valid
donor documentation. In 28 states (55%), people said they rely on family
confirmation in order to avoid potential legal disputes. Ethical
considerations are another major reason that next-of-kin consent is required.
It is a factor in 25 states (49%) where medical personnel feel that it is
morally wrong to ignore objections raised by survivors. Finally, 15 states
(29%) cited fear of bad publicity as a reason for obtaining family consent for
organ removal.
393
Only four states (8%) take full advantage of the provisions of their
anatomical gift acts. Transplant coordinators in these states explained that
potential donors' intentions—legally documented—cannot be vetoed by others.
The family is simply informed of the procedure as a matter of formality.
The results of the inquiry reported here, however, suggest several areas
which should be further addressed in the future (Oksa and Pasternack, 1981;
van der Vleit and Koostra, 1982; van der Vleit et al., 1982; Barnes, 1983).
Clearly there are a number of important issues concerning the impact of
laws pertaining to anatomical gifts. It is evident that the original goal of
the measure has not been achieved; that is, the Uniform Anatomical Gift Act
alone has not succeeded in more closely matching supply to demand.
There is little doubt that a greater number of signed donor cards would be
likely to increase the supply of donor organs—transplant coordinators across
the country emphasized that very few families withhold consent when made aware
of the decedent's donor documentation. The fact that only a small percentage
of donors actually have donor cards raises questions about current methods of
document distribution. The work of private groups or institutions is
limited. There are certainly things that can be done to increase card
distribution, such as making cards available in more hospitals, doctors'
offices and schools, but these efforts cannot reach all groups or individuals
in the public sector. In contrast, the government not only has the greatest
access to the public, but also has the capability of devoting substantial
monetary resources to the task of promoting organ donation.
Should the government play a more aggressive role in promoting organ
donation? Should it assume the responsibility of at least presenting the
issue to every adult? Every state could do more to ensure that the organ
394
donor section on the driver's license is more than a box that one probably
ignores or forgets to fill in.
People we talked to indicated that the greatest difference among programs
and hospitals is not in how they identify donors but rather in how
consistently they attempt to do it. Building a network of involved, motivated
referral sources among medical personnel requires a great deal of effort,
patience, and farsightedness on the part of organ procurement agencies.
The results of our inquiry also suggest that the Uniform Act is largely
ignored when it comes to matters of consent. Although the Act recognizes
donor documents as sufficient evidence of the decedent's intentions and even
extends blanket protection to physicians who remove organs while "acting in
good faith," the vast majority of medical institutions in this country will
not allow organ removal without consent from the next-of-kin.
Most institutions base this policy on their fear of prosecution, a definite
sign that they feel the protection offered them in the Uniform Act is not
sufficient.
Legislation may or may not remove all perceived barriers to effective
organ procurement. There remains the question of how to deal with ethical
objections and the fear of bad publicity. Again, an important key to the
answer is education, both professional and public. Organ donation must be
presented in a positive light. If the attitudes of medical personnel and the
general public reflected the positive aspects of organ donation, ethical
objections and the fear of legal liability and bad publicity would not be seen
as such serious obstacles.
I would like to conclude my testimony with some comments on the National
Kidney Dialysis and Kidney Transplantation Study. This study is concerned
395
with the costs and benefits associated with various approaches to the
treatment of kidney failure. The purpose of the study is to identify which of
several treatment modalities is (are) least costly to the federal government
yet, at the same time, is (are) most beneficial to the patients being
treated. I think, at the outset, that we would all agree that cost should not
be the sole criterion upon which we base our judgment of the effectiveness of
alternative treatments. Yet, at the same time, we recognize that cost is a
very important consideration.
It is in this regard that kidney dialysis and transplantation raise some
very difficult questions which we must confront as a society. These questions
have to do with resource allocation and rationing. I have thoroughly
considered these issues in two papers which v.ill appear in the April 15, 1983
and April 22, 1983 issues of the Journal of the American Medical Association.
In my estimation, we have now reached a point where there is what I might call
a "new medical imperative," that being to develop policies and procedures for
making resource allocation and rationing decisions.
In 1982 it cost approximately $1.8 billion to treat about 65,000 ESRD
patients in the U.S. (Iglehart, 1982a; 1982b). This is up from $747.2 million
in 1978. While the actual cost per patient per year for treating ESRD has
decreased (when adjusted for the rate of inflation) (Lowrie and Hampers, 1981;
1982; Rettig, 1980a; 1980b), rising total program costs have led to a
reconsideration of the future viability of the ESRD Program.
Policymakers are also concerned that the outcomes experienced by many
patients are unsatisfactory, thus raising questions about the overall benefits
of the program as well. A most difficult question is now being asked: are
ESRD patients truly benefiting from long-term maintenance dialysis and kidney
10
396
transplantation? Recently, several studies have shown that the benefits
derived by many patients are relatively few (Gutman and Amara, 1978; Gutman et
al., 1981; Rennie, 1981; Tews et al., 1980; Poznanski et al., 1978). Indeed,
many ESRD patients appear to lead unacceptable lives characterized by frequent
hospitalization, family discord, and personal catastrophe. Thus, while it
cannot be denied that the ESRD Program has saved lives of patients with
chronic renal failure, attention is now beginning to focus on the quality of
their lives (Editorial, 1980; Editorial, 1981; Caplan, 1981).
In the National Kidney Dialysis and Kidney Transplantation Study, the
quality of life of 859 patients randomly selected from eleven dialysis and
transplant centers across the United States has been assessed. These results
show clearly that kidney transplantation, when successful, is a superior
treatment alternative to long-term maintenance dialysis of any kind. At the
same time, however, it is evident from our results that patients who have
experienced a failed kidney transplant have significant medical and
rehabilitation problems which distinguish them from successful kidney
transplant recipients. Thus, rather than use the results of our study to
promote kidney transplantation as the optimal treatment modality for end-stage
renal disease, I remain committed to the position that dialysis and
transplantation must be viewed as complementary rather than competitive
treatment modalities.
Over the past two days there has been some discussion of the cost of organ
transplantation. I would like to underscore the fact that the cost of dying
with untreated catastrophic disease is far less than providing even routine
treatment for a catastrophic disease. That is, if no attempt is made to
reverse the disease process upon the diagnosis of a condition such as
11
397
idiopathic cardiomyopathy or biliary atresia, dollars are saved. Yet, as a
society we obviously find it cruel to withhold even routine treatment. Thus,
the cost of a transplant procedure must be viewed as the marginal additional
costs which are incurred over and above routine medical care that would have
been provided regardless of whether or not the patient in question received a
transplant. For example, a patient who does not receive a transplant will
incur considerable medical expenses regardless of whether or not they receive
a transplant.
Despite this, however, we must recognize that there are truly limits to
how much we can realistically do to spare human lives from that which is truly
inevitable—death. For example, is it a wise use of scarce resources to do
everything imaginable to maintain the life of a patient with terminal cancer
whose prospects of living beyond a few months is virtually nil? Are these
resources not better spent in providing care to other patients who are likely
to benefit?
At the same time we find it is especially cruel when representatives of
major government insurance programs such as Medicare, Medicaid, and CHAMPUS as
well as private insurance companies decide not to pay for procedures such as
heart and liver transplantation. Yet, what we often fail to recognize is that
these coverage determinations, as I refer to them, are by no means simple. A
considerable amount of data much be amassed and analyzed to better understand
the implications--f inancial, legal, ethical, and sociomedical--of the
decisions we make. This is precisely what we are doing for the Federal
government in the HCFA-sponsored National Heart Transplantation Study. Is it
not unusual that at a time when we are considering the possibility that the
Medicare program is likely to go broke, we are suggesting that coverage be
12
-
398
expanded to include very expensive life-saving therapies such as liver
transplantation which is estimated to cost between $175,000 - $200,000 per
procedure? Is it not time that we begin to ask, how many of these procedures
can be supported by public funds?
With these remarks I do not intend to suggest that many of the costly
procedures we have discussed over the past two days are not worthy of
support. Indeed they are. What I want to suggest is that perhaps resource
allocations to public health care programs do not reflect the priority that
the public attaches to them. In effect, if the public wants only the finest
health care available, as was suggested yesterday, is it truly willing to pay
for it? And, do current allocations to publicly subsidized health care
programs reflect this public commitment? In effect, should more resources be
allocated to health care programs and less to alternative uses?
Ultimately we must recognize that the Brandon Hall's and the Jamie Fiske's
really serve to epitomize a much larger problem we must confront as a
society. There are many people in this world with a variety of medical
problems which can be treated if we are willing to expend the required
resources. But, since the necessary resources are truly finite, we must make
what some have referred to as "tragic choices." It is in making these
decisions that we come to recognize that illness, despite its tragedy, is part
of the human condition and that illness provides meaning and insight into the
human condition.
13
399
FOOTNOTES
1. All states and the District of Columbia, except: Illinois,
Massachusetts, Utah
2. All states and the District of Columbia except: Delaware, Florida,
Hawaii, Nebraska, Nevada, Pennsylvania, Washington
3. Colorado
4. Minnesota, Connecticut, Alabama, North Carolina
5. Michigan, North Dakota, Wyoming
6. Louisiana
7. Arizona, Illinois, Kansas, Mississippi
8. Montana, Kentucky
9. Alabama, Alaska, Arkansas, Connecticut, Delaware, District of Columbia,
Georgia, Hawaii, Indiana, Illinois, Indiana, Iowa, Kansas, Kentucky,
Louisiana, Maine, Maryland, Mississippi, Michigan, Minnesota, Missouri,
Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New
York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee,
Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin
10. District of Columbia, Georgia, Kentucky, Maryland, Massachusetts,
Missouri, Nevada, New Hampshire, North Carolina, Oregon, Virginia
400
REFERENCES
Barnes BA. Future trends in organ procurement. Heart Transplant. 1983;
2:88-93.
Bart KJ, Macon EJ, Whittier FC, Baldwin RJ, Blount JH. Cadaveric kidneys
for transplantation: a paradox of shortage in the face of plenty.
Transplant Proc. 1981a; 31:379-382.
Bart KJ, Macon EJ, Humphries AL Jr., Baldwin RJ, et al. Increasing the
supply of cadaveric kidneys for transplantation. Transplantation.
1981b; 31:383-387.
Caplan AL. Kidneys, ethics, and politics: policy lessons of the ESRD
experience. Journal of Health Politics, Policy and Law. 1981;
6:488-503.
Council on Scientific Affairs. Organ donor recruitment. JAMA. 1981;
246:2157-2158.
Crosby DL, Walters WE. Survey of attitudes of hospital staff to cadaveric
kidney transplantation. Br Med J. 1972; 4:346-///.
Editorial. Quality of life in renal failure. Br Med J. 1980; 7(12):97-98.
Editorial. Reaping the whirlwind. Hospitals. 1981; 55:55-56.
16
401
Evans RW. Health care technology and inevitability of resource allocation
and rationing decisions (first of two parts). JAMA. 1983a, (in press).
Evans RW. Health care technology and inevitability of resource allocation
and rationing decisions (second of two parts). JAMA. 1983b, (in press).
Gutman RA, Amara AM. Outcome of therapy for end-stage uremia: an informed
prediction of survival rate and degree of rehabilitation. Postgrad
Med. 1978; 64:183-194.
Gutman RA, Stead WW, Robinson RR. Physical activity and employment status
of patients on maintenance dialysis. N Engl J Med. 1981; 304:309-313.
Iglehart JK. Health policy report: funding the End-Stage Renal Disease
Program. N Engl J Med. 1982a; 306:492-496.
Iglehart JK. Medicare's uncertain future. N Engl J Med. 1982b;
306:1308-1312.
Lowrie EG, Hampers CL. The success of Medicare's End-Stage Renal Disease
Program: the case of for profits and the private marketplace. N Engl J
Med. 1981; 305:434-438.
Lowrie EG, Hampers CL. Proprietary dialysis and the End-Stage Renal Disease
Program. Dial Transplant. 1982; 11:191-204.
17
402
Oksa H, Pasternack A. Availability of cadaver kidneys for transplantation
from brain-dead donors. Scand J Urol Nephrol. 1981; 15:391-394.
Poznanski E0, Miller E, Salguero C, et al. Quality of life for long-term
survivors of end-stage renal disease. JAMA. 1978; 239:2343-2347.
President's Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research. Defining Death: Medical, Legal,
and Ethical Issues in the Determination of Death. Washington, D.C.:
U.S. Government Printing Office, 1981.
Rennie D. Renal rehabilitation: where are the data? N Engl J Med. 1981;
304:351-352.
Rettig RA. The politics of health cost containment: end-stage renal
disease. Bull NY Acad Med. 1980a; 56:115-138.
Rettig RA. Implementing the End-Stage Renal Disease Program of Medicare.
Publication No. R-2505-HCF A/HEW. Santa Monica, CA: The Rand
Corporation, 1980b.
Rivers SH. The Uniform Anatomical Gift Act. JAMA. 1982; 248:1452.
Sells RA. Let's not opt out: kidney donation and transplantation. J Med
Ethics. 1979; 5:165-169.
18
403
Stuart FP, Veith FJ, Cranford RE. Brain death laws and patterns of consent
to remove organs for transplantation from cadavers in the United States
and 28 other countries. Transplantation. 1981; 31:238-244.
Tews HP, Schreiber WK, Huber W, Zelt J, Ritz E. Vocational rehabilitation
in dialyzed patients: a cross-sectional study. Nephron. 1980;
26:130-136.
van der Vliet JA, Koostra G. The transplant coordinator: an answer to the
shortage of cadaveric donor kidneys. Neth J Med. 1982; 34:1.
van der Vliet JA, Kootstra G, Krom RA. Cadaveric organ retrieval for
transplantation. World J Surg. 1982; 6:478-483.
19
404
APPENDIX A
THE NATIONAL HEART TRANSPLANTATION STUDY:
AN OVERVIEW
The National Heart Transplantation Study:
An Overview*
ROGER W. EVANS, Ph.D.
ARNE ANDERSON, B.A.
BRADFORD PERRY, Ph.D.
Battelle Human Affairs Research Centers
Seattle, Washington
1
An announcement appeared in the January 22,
1981, issue of the Federal Register asking hospi-
tals and medical centers to participate in a study
of heart transplantation, now the National Heart
Transplantation Study.1 The announcement was
made by the Health Care Financing Administra-
tion (HCFA), the federal agency that is responsi-
ble for administering Medicare, Medicaid, and
other programs for the well-being of the nation's
aged, poor, and disabled.1 In its role as adminis-
trator of these programs, the HCFA must make
two types of policy decisions: (1) whether or not
an item or service is eligible for payment under
one of the foregoing programs, and (2) how much
to pay for a covered item or service.
Any emerging, new, or existing health care
technology, whether a procedure, device, or
drug, is of obvious concern to the Health Care
Financing Administration since it must decide
how federal funds will be used to pay for medical
expenses incurred by beneficiaries under the
programs it administers.
The need for a study on heart transplantation
became apparent when questions raised by then
Secretary of the Department of Health and
Human Services, Patricia Roberts Harris, about
the procedure could not be answered satisfactor-
ily. In fact, an ad hoc panel of 18 cardiologists
and cardiac and transplant surgeons assembled
by the National Heart, Lung, and Blood Institute
(NHLBI) at the request of the National Center
for Health Care Technology concluded that it
could make no "generalized or unqualified
statement" about the safety, efficacy, and rea-
sonableness of heart transplantation.3
Background
In November 1979, the Health Care Financ-
ing Administration first authorized payments for
heart transplantation procedures performed for
Medicare beneficiaries at Stanford University
Medical Center. This was an interim decision
based on preliminary findings by the Public
Health Service regarding the safety and efficacy
of heart transplants performed at that center.
When reimbursement was tentatively au-
thorized, HCFA anticipated that it would soon
be able to reach a final decision not only about
coverage at Stanford, but also on generally appli-
cable criteria for approving Medicare coverage of
heart transplantation at other facilities.
As HCFA proceeded to review Medicare
coverage of heart transplants, it decided that the
issues were much more complex than originally
thought and could not be immediately resolved
because the data were inadequate. There were
numerous questions, for example, on the
patient-selection process, the basis for assessing
safety and efficacy, the long-term social and eco-
nomic consequences of the procedure, broad
ethical considerations, the cost-effectiveness of
the procedure, and the potential, if any, for sub-
stantial expansion in the availability of heart
transplants. It was concluded that HCFA did not
have sufficient information at that time to de-
velop generally applicable coverage criteria.
The National Heart Transplantation Study
On June 12, 1980, Secretary Harris announced
the decision to exclude heart transplants from
Medicare coverage with the exception of a few
patients who had previously been selected for
and were awaiting transplants. This announce-
•Sponsored by the Office of Research and Demonstra-
tions of the Health Care Financing Administration, contract
number 500-81-0051. Dr. Evans, a research scientist at the
Seattle facility, is the project director of the study. Mr.
Anderson and Dr. Perry are project officers at the Health
Care Financing Administration in Baltimore and Washing-
ton, DC, respectively.
ManuscriptVeceived August 30, 1992
Manuscript accepted September 14. 1982
HEART TRANSPLANTATION / VOLUME II. NUMBER 1 / NOVEMBER 1982
85
405
ment was published in the Federal Register on
August 6, 1980. * At the same time, Mrs. Harris
announced that all new health technologies must
be evaluated not only for their medical efficacy
but also for their social consequences before
"financing their wide distribution."3
The decision to exclude heart transplants from
Medicare coverage was accompanied by an an-
nouncement that the HCFA, in close coopera-
tion with the Public Health Services' National
Center for Health Care Technology (NCHCT),
would conduct a study of the sort described by
Mrs. Harris. The National Heart Transplantation
Study was to address numerous issues, includ-
ing: need for heart transplantation in the U.S.,
availability of donor hearts, survival of heart
transplant recipients, cost of performing a heart
transplant and the routine care required thereaf-
ter, quality of life and level of rehabilitation en-
joyed by heart transplant recipients, and legal
and ethical issues pertaining to the selection of
candidates for heart transplantation. The major
objective of the study, once the foregoing
analyses were completed, would be to examine
the impact of potential coverage decisions on
beneficiaries, the Medicare program, and the
health care providers.
Selection of Institutions
to Participate in the Study
Six institutions were selected to serve as clini-
cal centers for the study: Stanford University
Medical Center, Medical College of Virginia,
University of Arizona Health Sciences Center,
University of Minnesota, University of
Pittsburgh, and Columbia Presbyterian Medical
Center. Although other institutions applied, it
was decided to limit the participation to only six.
It had been decided beforehand that cardiac
transplantation could not be considered as sim-
ply a surgical procedure. It was also decided that
clinical effectiveness and usefulness depend
upon careful and appropriate patient selection,
expert surgery and postoperative care, adequate
immunosuppression protocols, availability of
methods for immunologic monitoring and treat-
ing rejection, thorough procedures for patient
education, and established protocols for liaison
with the patient's own physicians for subsequent
lifelong care.
Criteria for selecting participating clinical cen-
ters were developed by the National Heart,
Lung, and Blood Institute, with the advice of an
advisory group of experts in cardiology, car-
diovascular surgery, organ transplantation, infec-
tious disease, and immunology. The three major
considerations were: (1) experience with a clini-
cal heart transplant program within the past five
years, (2) adequate patient selection criteria, and
(3) acceptable patient management plans and
protocols. These points, discussed in detail in the
Federal Register, are similar to the requirements
for a cardiac transplantation program described
by Copeland and Stinson.5
All participating clinical centers have agreed to
furnish, or make available, a wide variety of data
on heart transplants performed there, including
information on their facilities and personnel re-
sources, heart donor program, patient selection
criteria, transplant and patient care protocols,
patient follow-up care, patient survival, and pa-
tient charges.
Payment for Heart Transplants
As part of the study, the Health Care Financ-
ing Administration will pay for a total of 15 heart
transplants. The recipients must, however, be
Medicare beneficiaries at the time they receive
the transplant. To qualify for Medicare benefits a
patient must be over age 65 or have been de-
clared disabled for at least two years. Thus, be-
cause of the current age restrictions, any patient
eligible for such payment under the study guide-
lines must have been declared disabled.
Other factors that would preclude payment for
a heart transplant under the study guidelines in-
clude: advancing age (eg, beyond the age [nor-
mally about 50] at which the individual begins to
have a diminished capacity to withstand post-
operative complications), severe pulmonary
hypertension, irreversible and severe hepatic or
renal dysfunction, active systemic infection, and
any other systemic disease considered likely to
limit or preclude survival and rehabilitation after
transplantation. A history of a behavior pattern
or psychiatric illness considered likely to inter-
fere significantly with compliance with a disci-
plined medical regimen is an additional con-
traindication. These selection criteria have been
described in considerable detail in the heart
transplantation literature.*"10
At this time the study protocol calls for the 15
heart transplants to be distributed evenly among
the six participating medical centers. Thus, each
will be expected to do two heart transplants and
the remaining three will probably be distributed
on a first-come, first-served basis. Responsibility
for deciding on patient eligibility for a heart
86
HEABT TRANSPLANTATION / VOLUME II. NUMBER 1 / NOVEMBER 1982
406
transplant under the study will ultimately rest
with the Health Care Financing Administra-
tion.*
References
1. Newman H: Medicare program: Solicitation of hospitals and
medical centers to participate in a study of heart transplants. Fed-
eral Register 46: 7072-7075. 1981.
2. Schaefler LD: Role of the HCFA in the regulation of new
medical technologies, in McNeil BJ. Cravalho EG (eds): Critical
hsues in Medical Technology. Boston, Mass, Auburn House, 1982.
pp 151-161.
3. Knox RA, Heart transplants: To pay or not to pay. Science 209:
570-575, 1980.
4. Newman H: Exclusion of heart transplantation procedures
from Medicare coverage. Federal Register 45: 52296-52297, 1980.
5. Copeland JG, Stjnsoo EB Human heart transplantation.
Curr ProU Cardiol 4: 1-51, 1979.
6. Pennock JL, et al: Cardiac transplantation, rehabilitation, and
cost. / Thorac Cardiovasc Surg 83: 168-177, 1982.
7. Copeland JG, et al: Cardiac transplantation, a two-year expe-
rience. Heart Transplantation 1: 67-71. 1981.
8. Oyer PE, et aL Cardiac transplantation: 1980. Transplant
Proc 13. 199-204. 1981.
9. Lower RR, et al: Selection of patients for cardiac transplanta-
tion. Transplant Proc 11: 293-295, 1979.
10. Baumgartner WA, et aL Cardiac homotransplantation. Curr
Prokl Surg 16: 2-61, 1979.
•Further information on the National Heart Transplanta-
tion Study may be obtained by writing to: Roger W. Evans,
Ph.D., Research Scientist, Health and Population Study
Center, Battelle Human Affairs Research Centers, 4000
N.E. 41st St., Seattle, WA 98105.
HEART TRANSPLANTATION / VOLUME II, NUMBER 1 / NOVEMBER 1982 87
407
APPENDIX B
THE NATIONAL KIDNEY DIALYSIS AND KIDNEY TRANSPLANTATION STUDY
STUDY DESCRIPTION, STATEMENT OF OBJECTIVES,
AND PROJECT SIGNIFICANCE
Parti
DIALYSIS AMD KIDNEY
STUDY DESCRIPTION, STATEMENT OF
OBJECTIVES AND PROJECT SIGNIFICANCE
Roger W. Evans, PhD
Project Director and Principal Investigator
Louis P. Garrison, Jr., PhD
Diane L. Manninen. PhD
Battelle Human Affairs Research Centers
Health and Population Study Center
Seattle, Washington
The NKDKT Study is sponsored by the Office of Research and
Demonstrations of the Health Care Rnandno. Administration, Grant
No. 95^-97887/001.
Editor s Note: As an article prepared exclusively for tie read-
ers of Contemporary Dialysis, the Battelle Human Affairs
Research Centers is presenting the first report on its impor-
tant NKDKT Study to be published anywhere. It uses cost-
effective criteria for analyzing various treatment forms for
end-stage renal disease (ESRD), center and home hemo-
dialysis, peritoneal dialysis and transplantation. Much has
been written about the advantages and disadvantages of
each of the therapies, but such a uniform and comprehen-
sive study evaluating the impact of each form of treatment
on quality of life, including the financial cost of that therapy, is
necessary. The investigators acknowledge the limitations of
the study (described in detail in Part II), which are that the
centers were not selected by probability sampling pro-
cedures (although the patients within the centers were se-
lected randomly), the study is cross-sectional rather than
longitudinal, and cost data collection methods are imprecise.
In addition, assessing the influences of staff manipulation of
the treatment on its outcome is not included. However, the
NKDKT Study is clearly important, unique and significant.
The National Kidney Dialysis and Kidney Transplanta-
tion (NKDKT) Study is a two-year cooperative study
tha t is still being conducted ( the results will be ready
in January. 1983), involving almost 1,000 patients (325
home, 335 in-center, 140 peritoneal dialysis and 151 trans-
plant (951 J) at 11 dialysis and/or transplant centers
across the United States The ma/or objective of frie study is
to collect and analyze data necessary to better understand
the current status of chronic renal disease patients. In partic-
ular, the study focuses on five major areas: ( 1) quality of
life, (2) rehabilitation, (3) disability, (4) quality of care.
and (5) cost of treatment, including out-of-pocket medical
expenditures. The absence of information on these areas,
and the author's inability to ascertain the cost-effectiveness
of alternative approaches to the treatment of kidney dis-
eases are evidence of the need for this study. The following
article describes the current state of the renal care field at the
facilities, and the reasons for and contents of this study.
Recent studies have indicated that chronic renal disease
patients experience high levels of disability, are inadequately
rehabilitated and enjoy a relatively low quality of life.'"3
There is some evidence to suggest that rehabilitation and
quality of life are related to the type of therapy a patient is
on.4-* For example, many studies show that home hemo-
dialysis patients and kidney transplant patients generally
experience a higher quality of life than patients on in-center
hemodialysis. The nature of this relationship is suspect, how-
ever, since it is acknowledged that selection biases enter
into the assignment of patients to therapy.7- 10 This can hap-
pen because patients placed on home hemodialysis as well
as those who receive kidney transplants are often in better
health than patients placed on in-center hemodialysis. Thus,
before asserting a direct relationship between the type of
therapy and the quality of a patient's life, it is important to
take pretreatrnent patient differences into account.
Since there have been relatively few systematic large-
scale studies which examine the effect that type of therapy
has on patient quality of life, it has been difficult for the
dialysis and transplant community, as well as the federal
government, to decide which types of therapy should be
given priority. Existing reports on the lower costs and greater
advantages of home dialysis have undoubtedly influenced
June 1982 Contemporary Dialysis 55
408
the position of the lederal government which, in the absence
of unequivocal results, has chosen to endorse transplanta-
tion and self-dialysis. ' ' Public Law 95-292 ( June 1 3. 1 978 )
also makes this Federal position clear as does, to some
extent, the Proposed ERSD Prospective Reimbursement
Rate Regulations.
Although most persons would agree that home dialysis
and transplantation have certain distinct advantages over in-
center dialysis, it is evident that all types of therapy for
chronic renal disease have evolved to meet the special
needs of certain patients.8 Reviews on the status of various
types of therapy for chronic renal disease have recently
appeared in the literature, confirming the fact that one type of
therapy should not be promoted to the complete exclusion of
the others.5- ,2"'8
In order that future health policies adequately reflect the
needs of chronic renal disease patients, insure the highest
standards of practice within the medical community, and
promote the most effective use of public resources, the Na-
tional Kidney Dialysis and Kidney Transplantation Study was
undertaken. Rather than simply explore the direct relation-
ship between type of therapy and patient quality of life, it
was determined that a more exhaustive analysis was re-
quired in order to properly examine the direct and indirect
relationships of various patient characteristics, including sc-
ciodemographic factors, health status, functional impair-
ment, work disability, social environment, and type of
therapy on the quality of a patient's life.
Quality of life is primarily defined in terms of the patient's
level of life satisfaction, happiness, and general well-being,
although it is acknowledged that disability and rehabilitation
are frequently conceptualized as an integral part of the pa-
tient's quality of life matrix. Problems in measuring quality of
life are well-documented in the literature. ' 7_M
The scope of this study is not limited solely to the analysis
of quality of life parameters, but it also involves a critical
examination of the allocation of resources to and within the
kidney disease program. The role that public pressure has
played in influencing the allocation of scarce medical funds
and resources to the ESRD program is acknowledged.
Questions, though, are increasingly being raised about the
cost of the kidney disease program, its accountability and
benefits directly derived by patients. The focus of our partic-
ular research efforts are on the cost-effectiveness of various
approches (types of therapy) to the treatment of kidney
diseases: home hemodialysis, facility or in-center hemo-
dialysis, continuous ambulatory peritoneal dialysis (CAPD)
or continuous cycling peritoneal dialysis (CCPD), and
kidney transplantation.
To facilitate the process of making critical allocation deci-
sions, information on both the efficacy of various treatments
and their costs must be made available to decision makers in
a systematic fashion that will allow them to make valid com-
parisons among alternative uses of those resources ear-
marked for the kidney disease program. To implement the
conclusions from these comparisons, incentives must be
offered to providers and patients alike to adopt cost-ef-
fective medical practices. 24_26 The cost-effectiveness analy-
sis framework is particularly well-suited to the National
Kidney Dialysis and Kidney Transplantation Study, wherein
quality of life indicators must be incorporated with measures
of the cost of treating kidney disease. JS- "-31
OBJECTIVES
The objectives of the NKDKT Study are as follows:
• To determine the impact of the type of therapy for renal
disease on the quality of life of the patient;
• To incorporate quality of life measures with cost of care
indicators to permit a cost-effectiveness analysis of vari-
ous approaches to the treatment of kidney disease;
• To determine 'he impact of the type of therapy for renal
disease on the quality of care for the patient;
• To describe and quantify the nature and extent of dis-
ability among dialysis and transplant patients:
• To assess the potential for improving the lives of dialysis
and transplant patients by changes in types of therapy
or through the provision of rehabilitation services;
• To examine the opportunity costs and out-of-pocket
costs borne by ESRD patients and their families;
• To document nonremunerated costs borne by dialysis
and transplant facilities; and
• To identify costs borne by third party payors.
SIGNIFICANCE
Despite the billion-dollar cost of the ESRD Program, little is
known about the attributes and consequences of the pro-
gram beyond the financial costs. This study addresses that
gap by examining the effect of alternative types of therapy
on the lives of the patients treated. The significance of the
proposed research is evidenced by the following:
• The study is directed at a primary goal of the ESRD
legislation: improving the rehabilitation and quality of life
of ESRD patients;
• No systematic study has yet been made of the impact of
therapy on the quality of life of ESRD patients;
• To encourage appropriate therapies for dialysis pa-
tients, professionals and public officials need to know
about the tradeoffs among quality of life, quality of care,
and treatment costs of alternative therapies;
• The study will contribute to the development of more ef-
fective ways to achieve rehabilitation of dialysis patients
and to return them to normal productive lives for the
remainder of their lives;
• Information will be obtained on the extent of unmet
needs for therapy and rehabilitation of patients;
• The results of this study should afford an opportunity to
improve patient well-being by appraising the benefits of
various therapies in relation to their costs;
• This study represents one of the few attempts to docu-
ment comprehensively the total cost of ESRD, including
the out-of-pocket expenses borne by patients, as well
as the nonremunerated costs borne by dialysis and
transplant centers;
• Finally, this study seeks to assess the total cost of
ESRD comparatively under four alternative types of
therapy— in-center hemodialysis, home hemodialysis
CAPD, and transplantation.
SAMPLE DESIGN
The 1 1 dialysis and transplant centers selected to partici-
pate in this study constitute what is commonly referred to as
a "purposive sample" and is distinctly different from a
"probability sample." A purposive sample is a non-
probability sample and as such, one must be careful in mak-
56 Contemporary Dialysis June I9S2
409
ing inferences from this sample ol centers to the entire
population ol dialysis and transplant centers in the United
States. We selected these 1 1 centers because they have
characteristics which are critical to our analyses. For exam-
ple, we selected centers to maximize variation among them
for the following criteria:
• Geography ( state / region ) ,
• Type (limited care /full-care /both);
• Ownership (for-profit /nonprofit /state government);
• Size ( number of dialysis stations) ;
• Academic affiliation (university based /nonuniversity
based);
• Number of patients by type of therapy; and
• Service area (urban /rural).
Selecting Patients: All continuous ambulatory peritoneal
dialysis (CAPO) or continuous cycling peritoneal dialysis
(CCPO) patients are included in the sample. It has been
necessary, however, to select a random sample of home
hemodialysis patients, in-center hemodialysis patients and
kidney transplant patients. Our goal, ultimately, is to inter-
view 325 home hemodialysis patients. 325 in-center hemo-
dialysis patients, 150 CAPD or CCPD patients and 150
Kidney transplant patients.
DATA SOURCES
Data for this study are being obtained from multiple
sources through several data collection instalments. The
data sources include the patient, the patient's medical rec-
ord, and the patient's primary nephrologist, social worker or
renal nurse familiar with the patient's functional status. The
data collection instruments are described below;
1 . The Chronic Renal Disease Patient Interview Schedule
is an interviewer-administrated data collection instrument
that takes approximately 90 minutes to complete, and is the
primary data collection instrument for the study. The inter-
view occurs at the dialysis or transplant center or, in some
cases, the patient's home.
2. The Chronic Renal Disease Patient Health, Medical
Care, and Treatment Expenses Diary is a booklet each pa-
tient is asked to maintain for one month. The patients are
asked to keep a record of illness behavior, utilization of
health services, medical expenditures, and a daily record of
how well they follow their diet, the extent to which they
exercise and how well they feel. We acknowledged at the
outset that responses to the patient diary are likely to be
lower than desired, because the period of time for which
they are being asked to keep the diary is lengthy and the
types of data are complex. Nevertheless, there is a clear
need to collect these data in a more systematic manner than
previous attempts.
3. The Chronic Renal Disease Patient Medical Records
Data Abstraction Form is intended to obtain pertinent medi-
cal data from the patient's chart (with the patient's written
consent); a data collector for the study carries out this ab-
straction process. In addition, the patient's primary nephrol-
ogist. a social worker, or a renal nurse familiar with the
patient's functional status records what comorbid ( for ex-
ample, diabetes) conditions a patient has and to what ex-
tent these impair the patient; an assessment is also made of
the patient's ability to work.
4 The Dialysis and Transplant Center Survey obtains data
on various dialysis and transplant cenler characteristics.
This instrument is jointly completed by the medical director
and administrator of each center, with appropriate input Irom
the social work and nursing staff.
5. In addition to the above data sources, we also have
access to the Medicare-billed charges data (or each Medi-
care-eligible patient included in the study. These data are
maintained through the Health Care Financing Administra-
tion's End-Stage Renal Disease Medical Information Sys-
tem. D
Editor's Note: Roger W. Evans. PhD. a medical sociologist, scientist and
research principal investigator ol the $500,000 NKDKT Study, is also
principal investigator of the S553.000 National Heart Transplant Study
still being conducted, and has presented and published a number ol
papers on ESRO-relaled topics. He is currently a special consultant ol
the Site Visit Team ol the NIH National Institute ol Arthritis. Oiabetes. and
Digestive and Kidney Diseases: special consultant lor the HCFA ESRD
Program, and member of the National ESRD Rehabilitation Task Force.
LouisP. Garrison. Jr.. PhD {bachelor' sand doctoral degrees in econom-
ics), a research scientist at Battelte. has been involved in extensive
medical studies Diane L. Manninen. PhO (bachelor's degree in mathe-
matics. MA and PhO in geography), is also a research scientist at Bat-
telte. and has been involved in medical, labor and nuclear power
socioeconomic studies.
Questions and correspondence concerning the NKDKT Study should
be directed to Roger W. Evans. PhD. Batteile Human Affairs Research
Centers. Health and Population Study Center. 4000 N.E. 41st St.. Seat-
tle. WA 98105.
Watch for Part II of the National Kidney Dialysis
and Kidney Transplantation Study in the August is-
sue of Contemporary Dialysis.
REFERENCES
1 . Bean. J.F.. Jr.. Makowiecki. M . and Yessian. MR.. The End-Stage
Renal Disease Program- A Service Delivery Assessment. Boston.
MA. Otfice of Service Delivery Assessment. Department ot Health
and Human Services. 1980.
2. Gutman. B.A.. Stead. WW., and Robinson. RR. "Physical Activity
and Employment Status of Patients on Maintenance Dialysis."
NEJM. 304:309-313. 1981.
3. Evans. R.W.. Blagg. C.R., and Bryan. FA., "Implications for Health
Care Policy: A Social and Demographic Profile ol Hemodialysis Pa-
tients m the United States," JAMA. 245:487-491. 1981.
4. Evans. R.W and 8lagg. C.R.. "The Conceptualization and Measure-
ment ol the Social Costs ol End-Stage Renal Disease." In E A
Friedman ( ed. ) , Strategy in Renal Failure. Second Edition, New
York: John Wiley and Sons, in press.
5. Guttmann. R.D., "Renal Transplantation (second ot two parts)."
NEJM.301 1038-1048. 1979
6. Tews. H P., Schreiber. W K.. Huber W . Zelt. J . and RiQ. E.. "Voca-
tional Rehabilitation in Dialyzed Patients: A Cross-sectional Study."
Nephron, 26:130-136. 1980.
7 Evans. R.W.. "The Treatment ol Kidney Disease: An Analysis ol
Medical Care Process. Medical Care Structure, and Patient Out-
comes." (Ph D Dissertation ). Durham. NC: Department ol Sociol-
ogy, Duke University. 1979.
8. Evans. R.W. "Center or Home Dialysis?." NEJM. 301(21 ):1 188.
1979
9. Simmons. R G.. "Social and Psychological Adjustment of Adult
Post-transplant Patients." in EA. Friedman ( ed. ) . Strategy in Renal
Failure. New York John Wiley and Sons, pp 463-482. 1978
10 Gutman. R A and Robinson. R R . "Outcomeof Treatment for End-
Stage Renal Disease." Arch Intern. Med.. 138:1469-1470. 1978.
1 1 Comptroller General ol the United Stales. "Treatment ol Chronic
Kidney Failure Dialysis. Transplant. Costs, and the Need lor More
Vigorous Efforts " Publication No MWD-75-53. Washington. DC:
Department ol Health. Education and Welfare, June 24. 1975
12 Guttmann. R 0 , "Renal Transplantation (first ol two parts)."
NEJM. 301 975-982. 1979
13 Manis. T and Friedman. EA., "Dialylic Therapy lor Irreversible
Uremia (first ol two parts). ' NEJM. 301 1260-1265. 1979.
14 Mams. T and Friedman. E A , "Dialytic therapy for Irreversible
Uremia (second of Iwoparls)." NEJM. 301 1321-1328. 1979
June 1982 Contemporary Dialysis 57
410
15 Popovich. n P . Moncnel. J W . Nolph. K D . Ghods. K O . Twar-
dowski, Z J . and Pyle. W K . "Continuous Ambulatory Peritoneal
Dialysis. " Ann Intern Med. 88:449-456. 1978
16. Nolph. K D . Sorkin. M . Rubin. J . Arlama. D . Prowant. B . Frieto.
B and Kennedy. D . "Continuous Ambulatory Peritoneal Dialysis
Three Years Experience at One Center." Ann Intern Med.
92 609-613. 1980
17. Clufl. LE.. "Chronic Disease. Function and the Quality ol Care." J
Chron Dis. 34:299-304. 1981
18 Andrews. FM. "Social Indicators ot Perceived Lite Quality." Social
Indicators Research. 1:279-299. 1974.
19. Andrews. FM. and Withey. SB.. "Developing Measures of Per-
ceived Lite Quality. Results Irom Several National Surveys " Social
Indicators Research 1 : 1-26.
20 Andrews. FM and Wilhey. S B . Social Indicators ot Well-Being
American's Perceptions ot Quality. New York: Plenum Press. 1976.
21. Bunge, M.. "What is a Quality ol Lite Indicator?." Social Indicators
Research. 2:65-79. 1975.
22. Campbell, A.. Converse. P.E., and Rodgers. W.L.. The Quality of
American Lite. New York: Russell Sage Foundation. 1976.
23. Rodgers. W.L. and Converse. .P.E.. "Measures ol the Perceived
Overall Quality ol Lite." Social Indicators Research. 2:127-152.
1975
24 Wemslein. M C . and Stason. W B . Hypertension A Policy Per-
spective. Cambridge. MA: Harvard University Press. 1976.
25 Wemslein. M.C. and Stason. W B.. "Foundations ol Cost-Effec-
tiveness Analysis lor Health and Medical Practices " NEJM
296 716-721. 1977
26 Wemslein. M.D.. Fineberg. H.V., Elstein. AS.. Frazier, H.S., Neu-
hauser. D . Neutra. R R . and McNeil. B.J., Clinical Decision Analy-
sis. Philadelphia. PA: WB Saunders. 1980.
27. Fuchs. V R . "What is CBA/CEA. and Why Are They Doing This To
Us?." NEJM. 303:937-938. 1980
28 Weisbrod. B A.. "Costs and Benefits ol Medical Research: A Case
Sludy ol Poliomyelilis." J. Political Economy. 79:527-544. 1971
29 Zeckhauser. R.. Harberger. A . Haveman. P.. Lynn. L . Niskanen.
W, and Williams. W (ed). Benefit-Cost and Policy Analysis. Chi-
cago: Aldine. 1975.
30 Ollice of Technology Assessment. Assessing the Efficacy and
Safety ot Medical Technologies. Stock No. 052-003-O0593-O.
Washington. D.C: U.S. Government Printing Office. 1978.
31. Rennie, D. "Renal Rehabilitation— Where Are the Data?." NEJM.
304:351-352. 1981.
"Letters to HCFA "
Continued from page 25
a reliable foundation on which to base
reimbursement rates for FY 1 983. Sim-
ilarly. HHS cannot support the assump-
tion that the limited cost data Irom less
than five percent ol facilities with home
dialysis programs (including 10 of the
13 largest home programs) form a reli-
able foundation on which to base pro-
spective rates.
2. HHS cannot support the assumption
that the use of home dialysis is prin-
cipally affected by the reimbursement
system and paying physicians and fa-
cilities a "bounty" for home patients
will significantly increase the use of
home dialysis.
3. HHS cannot support the assumption
that home dialysis is medically appro-
priate for 30-40 percent ol the US di-
alysis population over the next five to
seven years
4. HHS cannot support the assumption
that home dialysis is significantly less
expensive than efficient in-center
dialysis.
5. HHS cannot support the assumption
that for purposes of setting a prospec-
tive rate for the first year of this new
reimbursement system, use of the me-
dian of the cost data is appropriate.
6. HHS cannot support the assumption
that the impact oi the new system in
paying 46 to 60 percent of the hospital-
based facilities and 28 to 40 percent ol
independent facilities less than their
costs, will not materially affect access
to care and deprive Medicare benefic-
iaries of their entitlements.
7. WHS cannot support the assumption
that economic efficiency, innovation
and competition are promoted by the
proposed composite, dual rate reim-
bursement system. . . .
The solution is two fold: first, set the
rales at a realistic level which does not un-
derreimburse all facilities and which pro-
vides an incentive lor low-cost providers to
expand and replace high-cost providers;
and secondly, eliminate the exception pro-
cess completely, or at least eliminate the
"isolated essential facility" criterion. In
fact, we would submit that elimination ol
the present exception rates would save a
tremendous amount of Medicare dollars
and would make the system more equita-
ble and competitive. . . .
Home Dialysis: HHS places an enor-
mous confidence in home dialysis as a
more acceptable mode of therapy than in-
center dialysis as well as the principal
means for cost savings to Medicare There
is no evidence to support this confidence,
and the data and experience that are avail-
able demonstrate that home dialysis is not
a panacea lor patients or the public.
The keystone of the policy shift an-
nounced in the NPRM is the strongly held
belief by HHS that home dialysis is signif-
icantly less expensive than in-center di-
alysis, yet the HHS data clearly contradict
this belief. As previously mentioned, the
$97 median cost ol home dialysis is sus-
pect, because the sample included only
five percent of all home dialysis programs
and the sample was heavily weighted in
favor of the largest and most efficient pro-
grams. Moreover, the cost evaluation did
not include universally recognized auxiliary
costs associated with home dialysis,
namely: ( 1 ) the cost of hospitalization as-
sociated with higher morbidity among
home patients; (2) certain capital and op-
erating costs such as plumbing and electri-
cal construction costs and additional utility
expenses which are not included in the
costs of the home dialysis sponsor; and
( 3) the opportunity cost of labor furnished
by a family member who assists the patient
on dialysis. Moreover, it's not dear from
the NPRM whether the cost of the equip-
ment is included in the $97 figure. It also is
important to note that the 1 7 percent ol the
dialysis population currently using home di-
alysis is a very select group ol patients. As
the home patient population expands,
sicker, older and poorer patients will be
added to this population, and the median
cost can be expected to increase substan-
tially A more comprehensive study con-
ducted by the GAO which tracked the cost
o( home care for 308 patients concluded
that the median cost of such care was
$ 1 05.34 per treatment, again based on the
present selective sample of healthier
patients. . . .
Finally, we believe that the additional
$20 per treatment proposed lor self-care
training to be grossly inadequate, and to
the extent it underreimburses facilities for
self-care training costs, the proposal disin-
cents facilities from encouraging home di-
alysis. The one-on-one training ratio and
the necessity ol having a top quality in-
structor who can teach and motivate pa-
tients cost far more than $20 per
treatment. . . .
Constantine L. Hampers. MO
Chairman ol the Board ol Directors
President
National Medical Care. Inc.
Boston. Massachusetts
DIRECTORY OF ADVERTISERS
W.L. Gore 19
International Tcchnidync Corp.
Inside Back Cover
NAPHT 45
Oryanon Tcknika Corp 39
Physio-Control Corp 27
Abbott Laboratories S, IS, 37
American Medical Products Corp.
Inside Front Cover, 7
Cox Instrument II
Extracorporeal Inc 34-35
Gambro, Inc , , Back Cover
S8 Contemporary Dialysis June 1982
Sponcidin Company 25
Stuart Pharmaceuticals 3
Terumo Corporation, USA 22-23
Travenol Laboratories 4 1,49
United Medical Products, Inc 30-31
411
Part II
CONCLUSION
(Continued from June 1982 Issue)
DIALYSIS AMD KIDNEY
STUDY DESCRSPTiON, STATEMENT OF
OBJECTIVES AND PROJECT SIGNIFICANCE
Roger W. Evans, PhD
Project Director and Principal Investigator
Louis P. Garrison, Jr., PhD
Diane L Manninen. PhD
Battelle Human Affairs Research Centers
Health and Population Study Center
Seattle. Washington
The NKDKT Study is sponsored by the Office of Research and
Demonstrations ol the Health Care Financing Administration. Grant
No. 95-P-97887/0O1.
The data to be collected for this study can conve-
niently be grouped into 1 3 categories. These catego-
ries and an exhaustive list of variables to be
measured are provided in Table I.
Where feasible, we have used standard measures of
those variables most critical to the study (e.g., quality of life,
health status) . These have been used for two reasons: ( 1 )
the reliability and validity of these measure are known; and
(2) the availability of comparison groups on these mea-
sures (e.g., people with other chronic diseases, the general
population) . Furthermore, our use of measures with demon-
strated reliability and validity has saved considerable irre-
placeable time and resources (a complete listing of the
standard measures incorporated in this study, an indication
of previous surveys in which the measures have been used,
and citations to the appropriate literature are all provided in
Table II).
The issue of comparison groups is also important. This
study is not experimental in the sense that patients are ran-
domly assigned to experimental and control groups to see
what effect the type of therapy has on patient quality of life,
rehabilitation and disability. In other words, the study is not a
clinical trial intended to identily the most efficacious treat-
ment for chronic renal disease Although we plan to prepare
frequency distributions and scale scores lor all patient
groups, the desirability of comparing the responses of ESRD
patients with those of the general population or with those of
other chronically ill patients is obvious.
Thus, by using the standard measures which have had
wide application elsewhere, we enhance our ability to make
comparisons across these other groups Unfortunately,
most studies of chronic renal disease patients have failed to
36 Contemporary Dialysii September 1982
include comparison groups, such as nondialyzed renal pa-
tients, nonrenal chronic medical patients and nonpatients.
Our use of standard measures represents an effort to close
this gap.3
DATA ANALYSIS
Although the analyses performed in this study are pri-
marily directed toward testing two multivariate statistica
models (one concerning the quality of life of ESRD patients
and the other concerning the quality of care they receive)
the model-testing exercise represents the final stage in e
multiple-stage approach to data analysis. Simple descriptive
statistics are used to answer the following types o
questions:
• What is the quality of life of ESRD patients?
• How has or has not ESRD impacted on the family of the
patient?
• What is the level of disability ( as measured by functions
indices) of ESRD patients?
• What proportion of ESRD patients can be expected tc
return to work?
• What proportion of ESRD patients do return to work?
• What rehabilitation services are available to ESRC
patients?
• What percent of ESRD patients were working before tb
onset of their condition?
• How markedly is the health status of ESRD patients a
fected following a kidney transplant?
In providing answers to the above questions, no attempt i
made to explain how the means, proportions, or other me;
sures of central tendency are affected by other variables in
multivariate model. From a policy perspective the foregoin
are more important questions to be answered. For example
412
in attempting to justify the existence ol a health program or
policy, the policymaker' is often called on to demonstrate the
efficacy of the program This is frequently achieved by citing
statistics on the level of disability and rehabilitation of the
people served under the program. However, when questions
of efficacy are not answered straightforwardly (e.g., what
type of therapy is best for ESRD?) ; there is ambiguity con-
cerning the study results and attempts must be made to
provide plausible explanations. From the perspective of the
data analyst, this is when questions of a bivariate or multi-
variate nature must be addressed. The following questions
fall in this category;
• What type of therapy maximizes the rehabilitation and
quality of life of ESRD patients?
• How does the health status of the ESRD patient impact
on family life?
• How does the patient's health status affect his/her ability
to work?
• In what way does disability affect the ESRD patient's
ability to work?
• Does a supportive social environment enhance the prob-
ability that an ESRD patient will return to work?
• How do various demographic variables affect the pa-
tient's quality of life and ability to return to work?
• Is functional impairment among ESRD patients differen-
tially affected by various sociodemographic variables?
These questions represent attempts to answer or further
address questions where the study results may be ambigu-
ous and defy ready interpretation.
Still another level ol analysis pursued involves the testing
ol multivariate models wherein the relationships among sev-
eral variables are investigated. As already noted, two such
models are postulated, one dealing with quality of life and
one with quality of care. These causal models, as we might
refer to them, force us to state testable multivariate hypoth-
eses. Analytically they are more complex than simply exam-
ining bivariate relationships or the statement of simple
descriptive statistics. Their complexity derives from the fact
that multiple variables are analyzed simultaneously in an
effort to understand better the direct, indirect and total effect
that variables have on each other. For example, the quality
of life model which we plan to test states that type of therapy
both directly and indirectly affects the quality of a patient's
life. Other variables in this model include: sociodemographic
characteristics, health status, functional impairment and so-
cioenvironmental characteristics ( see Figure 1 ) . This model
suggests that quality of life is a function of several variables
and that the relationships among these variables is worthy of
consideration.
The quality of care model involves the analysis of slightly
fewer variables and suggests that, for purposes of this
study, there are four viable indicators of the quality of care a
patient receives. These are mortality, hospital admissions,
number of days hospitalized and physician visits or other
contacts (e.g., telephone calls) the patient makes to the
dialysis or transplant center.
fABLE 1
INDEX OF DATA REQUIREMENTS
1.
Quality of Life
9.
Expenditures
lift satisfaction
» out-of-pocket health care expenditures
• well-being
drug use and expenditures (presecription and nonprescription drugs)
happiness
payments to doctors, clinics, and hospitals
2.
Type of Modality of Therapy
Medicare charges data
► in-center hemodialysis (including self-care)
amount paid by third parties for treatments and drugs
home hemodialysis
payments for miscellaneous medically-related expenditures
» continuous ambulatory pertioneal dialysis (including
10.
Impact of Treatment
continuous cycling peritoneal dialysis)
impact upon the family
» Transplantation
impact upon social activities
3.
Disability
11.
Social Support
• types and levels of patient disability
support from family and relatives
» work limitations
friendships and associations
► frequency of disability days
12.
Medical and Treatment
limitations in activities of daily living
diagnosis
experience with disability benefit programs
patient adherence to treatment regimens (including daily diet record)
4.
Rehabilitation
type of diatyzer used
use of rehabilitation services
square meter hours of dialysis
experience with government benefit programs
kidney transplant experience
experience with job training programs
kidney disease treatment history
5.
Work
postdialysis syndrome
work history
time of dialysis
employment status
level of daily exercise
kind of work (work characteristics)
13.
Facility and Center-Based Data
6.
Health Status
Patient eligibility data (number of Medicare and non-Medicare patients)
comorbidity
facility operation data (number of shifts and operating days per week)
illness days
patient load data (breakdown of number of patients by type of therapy)
perceived health
treatment load data (breakdown of number of treatments by type of
satisfaction with health
therapy)
anginaccess problems
transplant data (number of patients transplanted, approximate survival
7.
Utilization of Health Services
rates)
number of hospital admissions
rehabilitation program components (services provided, arrangements
number of days hospitalized
between the center and the community)
contact w»th dialysis and transplant center staff
other considerations (hospital or freestanding unit, nonprofit or for-
(including telephone)
profit status, number of dialysis stations, dialyzer reuse, delivery
use of outpatient services
system, staff turnover)
8.
Income and Assets
income (source and amount)
assets
38 Contemporary Dialysis September 1982
413
TABLE II
STANDARD MEASURES OF VARIABLES IN THE NATIONAL KIDNEY DIALYSIS
AND KIDNEY TRANSPLANTATION STUDY
• VARIABLE
PREVIOUSSURVEY AND/OR INDEX NAME
REFERENCES
Quality of Life (Life Satisfaction)
• Standard of Living
The Quality of American Life Study
18
• Life as a Whole
19.20
• Savings and Investments
22
• Family Life
• Friendships
• Marriage
Quality of Life (Well Being)
• General Sense of Well-Being
32
• General Well-Being
General Well-Being Schedule,
33
Health Interview Survey
34
• Positive and Negative Affect
35
• Index of Well-Being
The Quality of American Life Survey
22
Quality of Life (Happiness)
National Commission on Mental Illness
36
• Level of Happiness
and Health Survey; The Quality of
35
American Life Survey
22
Quality of Life (Life in General)
• General Life Satisfaction
37
• General Life Satisfaction
The Quality of American Life Survey
22
Functional Impairment
• Specific Impairments
Rand Corp.. Health Insurance Survey
38.39
• Specific Impairments
1978 SSA Disability Survey
40-42. 43.
44
• General Composite Index
Karnofsky Index
45,46. 2
Work Limitations
• Kind and Amount
Health Interview Survey; National Medical Care
47
Expenditures Survey; National Medical Care
48
Utilization and Expenditures Survey
Manifest Symptons of Physical and
1978 SSA Survey of Disability and Work
40,41,43.
44.
Emotional Limitations
49. 50. 31
Health Status
Sickness Impact Profile
52-54,
• Sleep and Rest
55-57
• Emotional Behavior
• Body Care and Movement
• Home Maintenance
• Mobility
• Social Interaction
• Ambulation
• Alertness Behavior
• Communication
. Work
• Recreation and Pasttimes
• Eating
Hospitalization
• Number of Hospital Admissions
Health Interview Survey
47
• Number of Days Hospitalized
Family and Social Support
Rand Corp. Health Insurance Study
58
Independence/Dependence
The Gift of Life Survey
59
Employment Status
The Renal Dialysis Study
60.61
Occupation
62
• Type of Work
• Employer
• Business and Industry
Income
• Level
1978 SSA Survey of Disability and Work
43. 44. 50
51
Utilization of Disability Benefits Program
1978 SSA Survey of Disability and Work
43. 44. 50
51
Utilization of Rehabilitation Services
1978 SSA Survey of Disability and Work
43,44.50
51
Job Training Program
1978 SSA Survey of Disability and Work
43. 44. 50
51
40 Contemporary Dialysis September 1982
414
In addition to the usual quality ol care outcomes cited
here, we also are considering other variables as proxy mea-
sures of quality of care. For example, postdialysis syndrome
is a problem for many dialysis patients. Some patients have
suggested that central dialysis delivery systems magnify
postdialysis symptoms and, in return, result in a lower quality
of life. Like quality of life, the quality of medical care cannot
be easily defined or described, as it is predicated on value
systems, standards and perspectives which vary from per-
son to person, group to group and place to place.
These perspectives, however, must be addressed in
providing the care which is desired and needed. The quality
of life and the quality of medical care, as described by Cluff ,
however, both have a common objective, and that is its
optimal or maximal personal function." Consequently, the
preceding variables, despite obvious limitations, serve as
our "indicators" of the quality of care a patient receives.
Within our model the quality of care a patient receives is
seen as a function of three classes of variables: personal
characteristics (e.g., age, sex, race), structural features of
the dialysis or transplant center (e.g., treatment load, num-
ber of procedures performed, size of staff, etc.), and the
type of therapy a patient receives. Our goal, nevertheless, is
to determine how quality of care is affected by these
variables. *
LIMITATIONS OF THE STUDY
This study, like any other, has certain limitations. Ac-
knowledging these limitations is important to the interpreta-
tion of the study results which also serves to point out the
direction of future research.
The first limitation is that the 1 1 dialysis and transplant
centers participating in this study were not selected on the
basis of probability sampling procedures. Thus, it is inap-
propriate to infer that the results of the study apply to all
centers and patients in the United States. Therefore, in a
statistical sense, the problem is one of inference. If we had a
probability sample of patients across the United States, we
would be able to generalize our results from the sample to
the entire population. Unfortunately, this is not the case.
Nevertheless, it is noteworthy that the major objective of this
study is not to make com(. .jisons across dialysis and trans-
plant centers. For example, we are not concerned with how
well patients at center A and center B are doing, com-
paratively speaking. Instead, we are only concerned with
being able to estimate quantities regarding the whole sam-
pling frame.
Our second major problem stems from the fact that the
study is cross-sectional rather than longitudinal. A cross-
sectional study design involves the collection of data at one
point in time, whereas a longitudinal design involves the col-
lection of data at several points in time. Most studies are
cross-sectional because longitudinal studies are very expen-
sive to conduct. Yet, a cross-sectional design makes it very
difficult to ascertain what existed or what occurred before
the point at which the data were collected.7- •• ,0
The problems engendered by a cross-sectional design,
however, are at least partially resolvable. Patients on various
types of therapy, for example, can be matched on numerous
salient criteria (e.g., age, sex, race, socioeconomic status,
presence of comorbidity, etc. ) and then compared to exam-
FIGURE 1
A THEORETICAL SOCIOMEDICAL MODEL OF THE QUALITY OF LIFE OF DIALYSIS PATIENTS
Seotember 1 982 Contemporary Dialysis 41
1 - t
415
me the effect varying types of therapy have on the outcomes
of interest This approach, in many regards, approximates
the mapr methodological objectives of case control studies
in epidemiology that are frequently cited in cancer-related
research.84 6S
A third limitation of the study is related to the relative
absence of facility-based data which reflect staff attitude to
the general problem of patient rehabilitation. Although it
could be argued that the staff of a dialysis or transplant
center can have a major influence on patient outcomes, this
study does not document these influences in any great de-
tail. The study does, however, inquire about the provision of
rehabilitation services and who had responsibility for arrang-
ing them.
Perhaps the last significant limitation of the study is with
regard to the source of our cost (i.e.. charge) data. Many
people have criticized the data maintained through the End-
Stage Renal Disease Medical Information System." Al-
though these data are clearly inadequate for some pur-
poses, they are the best data available to us to perform the
required cost analyses. Every attempt is being made to in-
sure and enhance the quality of the data, but to collect new
data for this study would be infeasible and beyond the cur-
rent availability of resources. O
"AH models are abstractions, and the models presented here contain a
relatively large number ot variables. By definition the models are in-
complete, but no model is completely able to explain all of the variance m
the event or phenomenon under study Consequently, it is relatively easy
to suggest other variables that are relevant to our proposed models Part
of the model testing exercise repostulates the models to the extent that
the appropriate data'are available.
Author's Note: A project the size of the National Kidney Dialysis and
Kidney Transplantation Study involves the contributions of many and is
acknowledged by the authors. Drs. Marilyn Bergner. Christopher R.
Blagg. John C. Crowley. Robert A. Gutman. Alan R. Hull, Edmund G.
Lowrie and Thomas L Marchioro all serve on the Advisory Committee for
the protect. The protect secretary is Mildred Gregory. Data collectors for
each participating center are: The Kidney Center (Boston). Tina Zuck-
man; Dallas Kidney Disease Center. Evelyn Warren. Carolyn Hamm. Dee
Ann Taylor; Northwest Kidney Center. Elena Andresen. Gina Gross. Mar-
ilyn Hoe and Cynthia Livak; Nalle Clinic Kidney Center, Tricia Ward:
Eastern Maine Hospital. Julie LaCombe: Presbyterian Medical Center.
Robert Zelanes: West Contra Costa Dialysis Center. Fern Stone; Bishop-
Clarkson Memorial Hospital, Debra Sanders. Indiana University Medical
Center. Lucy Hardison, Dialysis Clinics. Inc . Suzanne Jiran; Downstate
Medical Center, Ellen Pincus and Roberta Temes. A major contribution in
time and effort is also being made by the medical, nursing, social work
and administrative staff at each center We sincerely appreciate the
efforts of all involved, and finally, we are especially grateful to the pa-
tients who have given of their time to participate in the studv
REFERENCES
32. Cantril, H. The Pattern ol Human Concerns. New Brunswick, NJ:
Rutgers University. 1965.
33. Fazio. A.F. "A Concurrent Validational Study of the NCHS General
Well-Being Schedule." Series 2 Number 73. Publication No. ( HRA)
78-1347. Vital and Health Statistics Senes. Hyattsville. MD: Na-
tional Center for Health Statistics. 1977
34 Bradbum. N M The Strvcrure ot Psychological Well-Being Chi-
cago Aldine. 1969
35 Bradbum. N M and Capiovitz. D. Reports on Happiness. Chicago
Aldine. 1965
36 Gurin. G . veroft. J . and Feld. S . Americans View Their Mental
Health. New York Basic Books. 1960
37. Osgood. CE. Sua. G J . and Tannenbaum. P H . Ttie Measurement
of Meaning. Urbana, 1L: University ol Illinois Press, 1957.
38 Stewart. A I . Ware. J E . Jr . and Brook R H . Constnjction and
Scoring ot Aggregate Functional Status Indexes Volume! . Publica-
tion Number 4-2551-HHS. Santa Monica. CA: The Rand Corpora-
tion. 1981
39 Stewart. AL . Ware, J.E.. Jr , and Brook. R. H . Constnjction and
Scoring ot Aggregate Functional Status Indexes: Volume II. Appen-
dices. Publication Number N-1706-HHS. Santa Monica. CA: The
Rand Corporation. 1981.
40. Nagi. S Z Disability and Rehabilitation; Legal. Clinical, and Sett-
Concepts and Measurement. Columbus. OH: Ohio State University
Press. 1969.
41. Nagi. S.Z. "An Epidemiology ol Disability Among Adults in the
United States." Milbank Memorial Fund Quarterly. 54439-467
1976.
42. Nagi. S.Z. "The Concept and Measurement ot Disability." in E.D.
Berkowitz (ed.). Disability Policies and Government Programs.
New York: Praeger. pp. 1-15. 1979.
43 Bureau of the Census, 1978 Disability Survey. Form DIS-100.
Washington, DC: Bureau ol the Census. U.S. Department of Com-
merce. 1978.
44. Bureau ol the Census. 1978 Disability Survey Interviewer's Manual.
Publication Number DIS-106. Washington. DC: U.S. Department ol
Commerce. Bureau ol the Census. 1978.
45. Karnolsky. O.A. and Burchenal. H.J.. "The Clinical Evaluation of
Chemotherapeutic Agents in Cancer." in C.M. Macleod (ed.). Eval-
uation ofChemotherapeutic Agents. New York: Columbia University
Press, pp. 191-204. 1949
46. Hutchinson. T.A.. Boyd. N.F.. and Feinstein. A.R., "Scientific Prob-
lems m Clinical Scales as Demonstrated in the Karnolsky Index ol
Performance Status." J. Chron Diseas. 32:661-666. 1979.
47. Bureau of the Census. US. Health Interview Survey. Form HIS-i
( 1980). Washington. DC: Bureau ol the Census. U.S. Department
of Commerce. 1980.
48 Bonham. G.S and Corder. L.S.. NMCES Household Interview In-
stalments: Instnjments and Procedures 1. DHHS Publication No
(PHS) 81-3280 Hyattsville. M0: National Center for Health Ser-
vices Research. 1981.
49 Haber L . "Identifying the Disabled: Concepts and Methods on the
Measurement ol Disability." Social Security tor the Disabled; Social
Security Administration. December 1. 1966.
50 Bye. B and Schechter. E.. A Technical Introduction to the 1978
Survey ol Disability and Work. Baltimore. MO: Division ol Disability
Studies. Social Security Administration. 1979.
51. Duchnok. S.. A Measure ol Functional Capacity. ORS Working Pa-
per Series. Paper Number 4. Baltimore. MD: Division ol Disability
Studies. Social Security Administration. 1979.
52 Gilson. B.S.. Bergner. M . Bobbitt. R.A., et al. Revision and Testol
the Sickness Impact Profile 1973-74. Seattle. WA: Department ot
Health Services. School ol Public Health and Community Medicine.
University ol Washington. 1974.
53 Gilson. B.S.. Bergner. M.. Bobbitt. H.A.. et al. Further Tests and
Revisions ol the Sickness Impact Profile 1974-75. Seattle. WA:
Department of Health Services. School ol Public Health and Com-
munity Medicine. University ol Washington, 1975.
54 Gilson. BS, Bergner, M. Bobbin. R A . and Carter. WB . TheSick-
ness Impact Profile: Final Development and Testing. Discussion Pa-
per tt 14. Department ol Health Services. School of Public Health
and Community Medicine. University ol Washington, 1979.
55 Bergner. M.. Bobbitt. R.A., Kressel. S . Pollard, W.E.. Gilson. B.S..
et al. "The Sickness Impact Profile: Conceptual Formulation and
Methodology lor the Development ol a Health Status Measure."
Internal J. Health Services. 6:393-415. 1976
56 Bergner. M . Bobbitt. R.A.. Pollard. WE.. Martin. DP., and Gilson.
BS., "The Sickness Impact Profile: Validation ol a Health Status
Measure." MedicalCare. 14 57-67. 1976.
Continued on page 16
DIRECTORY OF ADVERTISERS
American Medical Products Corp.
Inside Front Cover
Amicon Corp 19
Continental Health Care, Ltd. ... 7
Dow Corning Corp 39
Extrjcorporeal Inc 10-11
Gambro, Inc Back Cover
Organon Teknika Corp 17
Physicians Reference Lab 35
Physio-Control Corp 27
Inside 8ack Cover
Renal Systems 37
Sporicidin Company 32
Siuart Pharmaceuticals 3
Travenol Laboratories 14-15
United Medical Products, Inc. . 30-31
VVycth Laboratories 22-23
42 Contemporary Dialysis September 1982
416
Continued from page /.?
bowel obstruction as a cause of previously unexplained
chronic, recurrent abdominal pain, nausea and vomiting
not related to infection.
Although the peritoneal air contrast study has proven
to be relatively free of complications, it is recommended
that m the presence of poor dialysate drainage or active
Figure 3A: Subcutaneous collection of air (arrows): (M = marker
on umbilicus; PC = peritoneal cavity).
Figure 3B: Contrast media (dark arrows) has drained from the
pehtoneal cavity (PC), along the catheter, and into a large
cavity (white arrows): (cross-table roentgenogram taken with
patient in hands and knees position).
intraabdominal problems, cannulography precede ni-
trous oxide insufflation. Upon completion of the pro-
cedure or in the event of severe abdominal pain,
contrast media and nitrous oxide should be removed. D
REFERENCES
I.Gandhi. V C. Humayun. H. M, Ing, T. S.. et al . "Sclerotic
Thickening ot the Peritoneal Membrane in Maintenance Per-
itoneal Oialysis Patients." Arch Int. Med . 140:1201-1203. 1980
2. Schmidt. R. W., Blumenkrantz, M.. "Peritoneal Sclerosis: A
Sword ol Oemocles' lor Peritoneal Dialysis," Arch. Int. Med.,
141:1265-1266, 1981.
3. Webb. 0. B., Fischer. 0. J., Williams. L. A., "Peritoneal Can-
nulography." Clin. Radiol. 30:193-195. 1979.
4. Vas. S. I.. "Peritonitis During CAPD: A Mixed Bag," Peril. Dial.
Bui.. 1:47-49. 1981.
5. Holley, H P., Tucker, C. T.. et al.. "Tuberculous Peritonitis in
Patients Undergoing Chronic Home Peritoneal Dialysis." ac-
cepted by Amer. J. Kid. Dis.. January, 1982.
6. Power. D. A.. Edward. N„ Catto, G. R. D„ et al.. "Richter's
Hernia: An Unrecognized Complication of Chronic Ambulatory
Peritoneal Dialysis." Bnt. Med. J.. 283:528. 1981.
7. Cunningham. J. T, Tucker, C. T.. "Peritoneoscopy in Chronic
Peritoneal Dialysis: Use In Evaluation and Management ot Com-
plications." accepted by Gl Endoscopy. 1982.
8. Dunnick, N. R., Jones. R. B., Doppman, J. L„ et al.. "Intra-
Pentoneal Contrast Infusion for Assessment of Intraperitoneal
Fluid Dynamics." AJR. 133:221-223, 1979.
NKDKT Study - Continued from page 42
57. Pollard, W.E.. Bobbin. R.A.. Bergner, M.. Margin, DP. and Gilson.
B.S., "The Sickness Impact Profile: Reliability of a Health Status
Measure." Medical Care. 14:146-155, 1976.
58. Oonald. C.A.. Ware. J.E.. Jr.. Brook. R. H.. Oavies-Avery, A.. Con-
ceptualization and Measurement ot Health tor Adults in the Health
Insurance Study: Vol. IV, Social Health, Santa Monica. California:
The Rand Corporation. R-1987/4 HEW. 1978.
59. Simmons. R.G., Klein. S.D.. and Simmons. R.L.. Gift of Life: The
Social and Psychological Impact ol Organ Transplantation. New
Yor*: John Wiley and Sons, 1977.
60. Bryan. FA ., Jr. and Evans, R.W.. "The Renal Dialysis Study: IV
Other Costs of Dialysis." Dial. Transplant., in press.
61. Evans, R.W. and Bryan. FA.. "The Renal Oialysis Study. II; Demo-
graphic Description of the Patient Sample." Dial. Transplant..
9(12):1 173-1 174. 1176-1178. 1980.
62. Blau. P.M. and Ouncan, O.D.. The American Occupational Struc-
ture, New York: John Wiley and Sons. 1967.
63. Osberg, J.W.. Meares. G.J.. McKee. DC. and Burnett. G.B . "Re-
search Issues in Psychological Studies of Chronic Dialysis." Psychi-
atry Research. 3:307-314. 1980.
64. Ibrahim. M.A. and Spitzer. W.O.. "Symposium on the Case-control
Study," J. Chronic Diseases, 32:1-146. 1979.
65. MacMahon. B. and Pugh. T.F.. Epidemiology: Principles and Meth-
ods, Boston: Uttle. Brown and Co., 1970.
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If we do not meet these tests, we are faced with a Hobson's Choice. We either have to cut our circu-
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16 Contemporary Dialysis September 1982
417
APPENDIX C
SELECTION CRITERIA FOR HEART DONORS
Variables Relevant to the Selection of Heart Donors
1)
2)
3)
4)
5)
6)
7)
8)
9)
DONOR AGE
CAUSE OF DEATH
trauma
CVA
brain tumor
drug overdose
cardiopulmonary arrest
other
TYPE OF DEATH
brain death
cardiac death
LOCATION OF DEATH
hospital
other
ASSOCIATED DISEASE
hypertension
diabetic
malignancy
sepsis
arteriosclerosis
other cardiac disease
other (specify)
DONOR SEX
INTRACARDIAC INJECTIONS DURING RESUSCITATION
CONTRAINDICATIONS
history of transient, severe hypotension after injury
known ECG abnormalities
murmurs on physical exam
RESTRICTED CONSENT FOR ORGAN DONATION
Kidneys
Corneas
Skin
Heart
Liver
Lungs
Pancreas
Body
418
Variables Relevant to the Selection of Heart Donors
(continued)
10) INFECTIONS
Pulmonary
Genitourinary
Subcutaneous
Abdominal
CNS
Systemic
11) DRUGS ADMINISTERED IN LAST 24 HOURS
isuprel
ar amine
intropin
mannitol
epinephrine
12) CHEST X-RAY RESULTS
widened mediastinum
pneumothorax ,
rib fractures
pneumonia
419
APPENDIX 0
NATIONAL CENTER FOR HEALTH STATISTICS
NATIONAL HOSPITAL DISCHARGE SURVEY
PUBLIC USE DATA TAPE DOCUMENTATION
■•-y^^*'.--^- " J;
ri -?<'.Wi.-'i-.7> ~^/'-\>v-rij ■
National HosprtaF Discharge 'Survey"
S^-s^.^
: S3
420
Public Use Data Tape
Documentation
National Hospital Discharge Survey
1979
US. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Office of Health Research, Statistics, and Technology
National Center for Health Statistics
Hyattsville, Maryland
August 1981
421
Errata:
r /
1. In section III. Tape Record Format, the variable Principal Expected
Source of Payment is missing. It should be included as item number
26 in tape location 131 (1 position) with the following legend:
1: Self -pay
2: Workmen's Compensation
3. Medicare
4. Medicaid
5. Other government payments
6. Blue Cross
7. Other private or commercial insurance
8. No charge
9 . Other
0. Not stated
2. Item number 22, Number of Beds (NMFI) , does not exist on the -
tape. J.
3. Item number 24, Hospital Ownership (NMFI), does not exist on
the tape.
422
1979 NATIONAL HOSPITAL DISCHARGE SURVEY (.NHDS)
MICRO-DATA TAPE DOCUMENTATION
ABSTRACT
Tnis material provides documentation for users of the Micro-Data Tapes
ot tne NhDS conctuctea by the national Center for health Statistics
CNCHS). Section I, "Description of the National Hospital Discharge
Survey," includes information on the nistory of the NHDS, the scope
of the survey, the sample, data collection procedures, medical coding
procedures, population estimates, measurement errors and sampling errors.
Section II provides technical details of the tape (number of tracks,
record length, etc. ). Section III provides a detailed description of
"-■?. contents of each data record, by location. Appendix A defines
certain terms used in this document, Appendix B provides population
estimates to allow the user to calculate rates, and Appendix C lists
Class 4 surgical procedures not coaea by NHDS.
TABLE OF CONTENTS
Page
I. Description of the National Hospital Discharge Survey 2
II. Technical Description of Tape 10
III. Tape Record Format 11
Appenaix A, Definition ot Certain Terms 22
Appendix B, Population Estimates 23
Appendix C, UHDDS Class 4 Procedures Not Coded by NHDS 24
423
1979 NHDS MICRO-DATA TAPE DOCUMENTATION 2
I. DESCRIPTION OF THE NATIONAL HOSPITAL DISCHARGE SURVEY
INTRODUCTION. --This document and its attachments allow one to use the
1979 micro-data tape which contains the data collected by the National
Hospital Discharge Survey conducted by the National Center for Health
Statistics. The National Hospital Discharge Survey provides a continuous
sample of hospital discharge records, collecting medical and demographic
information for calculating statistics on hospital utilization. The
survey consists of data abstracted from the face sheets of the medical
records for sampled inpatients discharged from a national sample of non-
federal short-stay hospitals. For a description of the survey design and
data collection procedures, see below. For a more detailed description
of the survey design, data collection procedures, and the estimation
process, see Reference 1.
HISTORY. --To provide more complete and precise information on the utilization
of the Nation's hospitals and on the nature and treatment of illness among
the hospitalized population, the NCHS in 1962 began exploring possibilities
for surveying morbidity in hospitals. A national advisory group was estab-
lished. The NCHS conducted planning discussions with other elements of the
Public Health Service. Hospitalization material from the Survey Research
Center of the University of Michigan, the American Hospital Association,
and the Professional Activities Study was examined and evaluated. In 1963,
a study by the School of Public Health of the University of Pittsburgh
under contract to the NCHS demonstrated the feasibility of an NHDS type
of program. An additional pilot study using enumerators from the Bureau
of the Census was conducted in late 1964 and confirmed the University of
Pittsburgh's findings.
Finally, with advice and support from the American Hospital Association,
the American Medical Association, individual experts, other professional
groups, and elements of the Public Health Service, NCHS initiated the
National Hospital Discharge Survey in 1964.
SCOPE OF THE SURVEY. --The National Hospital Discharge Survey encompasses
patients discharged from noninstitutional hospitals, exclusive of Federal
hospitals, located in the 50 States and the District of Columbia. For
purposes of the NHDS, a facility is considered a short-stay hospital
only if it meets the following criteria:
1. At least six beds are maintained for use by inpatients.
2. It is licensed as a hospital in States with licensure laws.
3. Inpatient medical care is provided under the supervision of
a licensed doctor of medicine or osteopathy.
4. Nursing service is provided 24 hours a day under supervision
of a registered nurse.
5. Separate medical records are maintained for each patient admitted,
6. The average length of stay for all patients is less than 30 days.
424
1979 NHDS MICRO-DATA TAPE DOCUMENTATION
SAMPLING FRAME AND SIZE OF SAMPLE. --The National Master Facility Inventory
of Hospitals and Institutions (NMFI) constitutes the sampling frame (universe)
for hospitals in the NHDS. NCHS has published a detailed description of
the NMFI, its contents, plans for maintaining it, and procedures for assessing
the completeness of its coverage (see Reference 2). The universe for the
survey consisted originally of 6,965 short-stay hospitals, excluding military
and VA hospitals, contained in the NMFI in 1963.
The sample of hospitals for 1970-1979 are shown in Table 1. In each year,
some hospitals refuse to participate and some are deemed out of scope,
either because the hospital had gone out of business or because it failed
to meet the NHDS definition of a short-stay hospital. The number of
hospitals which refuse to participate or are out of scope are also given
in Table 1, along with the number of participating hospitals. The sample
increased in several of the years to accommodate new hospitals.
Table 1
Number of Hospitals
Year
Sampled
Refused
Out of Scope
Surveyed
1970
465
46
24
395
1971
465
60
26
379
1972
497
45
28
424
1973
497
42
31
424
1974
497
38
33
426
1975
511
44
35
432
1976
511
53
39
419
1977
535
68
44
423
1978
535
74
48
413
1979
544
65
48
431
SAMPLE DESIGN. --All hospitals with 1,000 beds or more in the universe of
short-stay hospitals were selected with certainty in the sample. All
hospitals with fewer than 1,000 beds were stratified, the primary stratum
being the 24 size-by-region classes shown in Table 2. Within each of
these 24 primary strata, the allocation of the hospitals was made through
a controlled selection technique so that hospitals in the sample would
be properly distributed with regard to type of ownership and geographic
division. Sample hospitals were drawn with probabilities ranging from
certainty for the largest hospitals to 1 in 40 for the smallest hospitals.
The within-hospital sampling ratio for selecting sample discharges varied
inversely with the probability of selection of the hospital. The smallest
sampling fraction of discharged patients was taken in the largest hospitals,
and the largest fraction was taken in the smallest hospitals. This was done
to compensate for the fact that hopsitals were selected with probabilities
proportionate to their size class and to assure that the overall probability
of selecting a discharge would be approximately the same in each size class.
425
1979 NHDS MICRO-DATA TAPE DOCUMENTATION 4
Table 2. Distribution of short-stay hospitals in the universe (Master Facility
Inventory) and in the National Hospital Discharge Survey sample and the number of
hospitals that participated in the survey, by geographic region and bed size of
hospital: United States, 1979
Bed Size of Hospital
All
Regions
North-
east
North
Central
South
West
All Sizes
Universe
Total sample
Number participating
6-49 Beds
Universe
Total sample
Number participating
50-99 Beds
Universe
Total sample
Number participating
100-199 Beds
Universe
Total sample
Number participating
200-299 Beds
Universe
Total sample
Number participating
300-499 Beds
Universe
Total sample
Number participating
500-999 Beds
Universe
Total sample
Number participating
1,000 Beds or More
Universe
Total sample
Number participating
Number of Hospitals
8,017
544
431
1,784
132
110
3,521
70
44
223
8
6
1,897
80
61
301
14
11
1,411
122
99
298
26
22
624
98
76
195
31
26
411
98
86
113
25
22
135
58
48
45
19
15
18
18
17
9
9
8
2,148
153
116
3,196 •
176
143
1,489
83
62
899
18
13
1,670
30
19
729
14
6
486
20
14
' 737
32
25
373
14
11
412
34
27
479
43
34
222
19
16
166
27
20
165
24
18
98
16
12
134
32
26
111
29
29
S3
12
9
48
19
13
29
13
13
13
7
7
3
3
3
5
5
5
1
1
1
426
1979 NHDS MICRO-DATA TAPE DOCUMENTATION 5
In nearly all hospitals, the daily listing sheet of discharges was the
frame from which the subsamples of discharges were selected within the
sample hospitals. The sample discharges were selected by a random
technique, usually on the basis of the terminal digit(s) of the patient's
medical record number--a number assigned when the patient was admitted
to the hospital. If the hospital's daily discharge listing did not
show the medical record number, the sample was selected by starting with
a randomly selected discharge and taking every kth discharge thereafter.
DATA COLLECTION. --Depending on the study procedure agreed on with the
hospital administrator, either hospital staff or representatives of the
NCHS performed the sample selection and the transcription of information
from the hospital records to abstract forms. The abstract form used
for 1979 is shown in Figure 1. In about two- thirds of the hospitals
that participate in the NHDS, the medical records department of the
hospital performed this work. In the remaining hospitals, personnel
of the U.S. Bureau of the Census acting for NCHS performed the work.
Survey hospitals used an abstract form to transcribe data from the
hospital records. The abstract form provides for recording demographic
data, admission and discharge dates, discharge status, and information
on discharge diagnoses and surgical operations or procedures. All
discharge diagnoses were listed on the abstract form in the order of
principal diagnosis, or first-listed diagnosis if the principal diagnosis
was not identified, followed by the order in which all other diagnoses
were entered on the face sheet of the medical record. All operations
were listed in the order in which they were recorded on the face sheet.
Shipments of completed abstract forms for each sample hospital were
transmitted, along with sample selection control sheets, to a Census
Regional Office. Every shipment of abstracts was reviewed and each
abstract form was checked for completeness. Abstracts were then sent
to NCHS for processing.
MEDICAL CODING AND EDIT. --The medical information recorded on the sample
patient abstracts was coded centrally by NCHS staff. A maximum of seven
diagnostic codes was assigned for each sample abstract; in addition,
if the medical information included surgery, a maximum of four codes
for surgical operations and procedures was assigned. Following the
conversion of the data on the medical abstract to computer tape, a final
medical edit was accomplished by computer inspection runs and a review
of rejected abstracts. If sex or age of patient was incompatible with
the recorded medical information, priority was given to the medical
information in the editing decision.
The basic system for coding the diagnoses on NHDS sample patient abstracts
is the ICD-9-CM (see Reference 3). The ICD-9-CM section for Surgical
Operations, Diagnostic and Other Therapeutic Procedures is the coding
system used for surgical procedures and operations.
427
1979 Tape Documentation
Form Approved: O.M.8. No. 66-R0620
f^uJ.°J!lJ'ii',,l.A'\J,''!l7Vl0" "4"Ch """'I »•"»'« „ ido««lfie«l«« of .n .ndi.idual or of an 'establishment' -.7. 7. hVid
DEPARTMENT Of HEALTH. EDUCATION. ANO WELFARE
PUBLIC HEALTH SERVICE
HEALTH RESOURCES ADMINISTRATION
NATIONAL CENTER FOR HEALTH STATISTICS
MEDICAL ABSTRACT - HOSPITAL DISCHARGE SURVEY
A. PATIENT IDENTIFICATION
1* Hospital number
2. HOS number
3* Medical Record number
B. PATIENT CHARACTERISTICS
Month
4. Oate of admission . . .1
5. Oate of discharge . . .1
tC Residence ZIP Code I
_0
C«r
Oar
Year
7. Oate of Wr*.
m-m-m
8. Ate (Complete only
Dote of Birth not fiven,
if Uniu p D Years;
•en) .... I "" \J J □ Months
jjOO-ya
9. Sex (Mark one)
1 Quale
1 □ Female
> □ Not stated
10. Race or Color (Mark one) [ 1 O "•»'«
— i —
* □ Black
»□ Other
4 □ Not tested
11. Marital Staan (Mark one) j ' Q Married i □ Single i Q widowed i Q Divorced s □ Soporated • Q Not stated
12. Expected Source(s) of payment
Principal Other
rverk one) (afar* m mu apply)
t □ □ Self-par
a f~~l r~l Workmen's Compensation
i □ Q Medicare
aQ Q Medicaid
a Q Q Other lovsnvnint payments
e □ □ Blue Cross
?Q Q Orher prlvste or commsrclsl Insurance
»□ Q No charge
t □ □ Other (Sptelty)
'0 □ Q Not stated
13. Disposition of Patient (Mark one)
* Q Routine discharge/discharged home
3 Q Laft against medical sdvice
I Q Discharged/transferred to enocher
facllicr or organization
4 Q Oischatged/rsferred to organized
homo care service
»□ Died
• □ Not seated \
C. DIAGNOSES
Principal:
Other/addi tjonal:
1 1 Sao reverse side
D. SURGICAL AND DIAGNOSTIC PROCEDURES
Principal:
Other/additional:
Date:
Month Oar Year
m-m-m
m-m-m
cn-cxD-cn
m-m-m
m-m-m
□ NONE
I | See reverse side
Completed by
Oate
XUS COVSNIOISIII HWIIHtt 0"Kt: IST*-TSS>SSe
Figure I. Medical Abstract for the National Hospital Discharge Survey
65
428
1979 NHDS MICRO-DATA TAPE DOCUMENTATION 7
The Uniform Hospital Discharge Data Set (UHDDS) classifies ICD-9-CM
procedures into 4 classes. Classes 1-3 consist of "significant
procedures" - that is, procedures which carry an operative or anesthetic
risk or require highly trained personnel, special facilities, or special
equipment. Class 4 procedures are not considered significant; therefore,
reporting them is considered optional. The NHDS collects data on only
three class 4 procedures: circumcision (code 64.0); episiotomy (code
75.6); and removal of intrauterine contraceptive device (97.1). Other
class 4 procedures are not coded by NHDS and are listed in Appendix C.
POPULATION ESTIMATES. --Appendix B contains population estimates provided
by the U.S. Bureau of the Census. The estimates cover the U.S. civilian
noninstitutionalized population on July 1 of the data year. These
population estimates are consistent with those published in Current
Population Reports, Series P-25; however, these tables are not official
population estimates of the Bureau of the Census.
MEASUREMENT ERRORS.— As in any survey, results are subject to nonsampling
or measurement errors, which include errors due to hospital nonresponse,
missing abstracts, information incompletely or inaccurately recorded on
abstract forms, and processing errors. Less than 1 percent of the dis-
charge records failed to include age or sex of patient. However, race
was not stated for about 13 percent of all discharges. If the hospital
record did not state age or sex of patient, it was imputed by assigning
the patient an age or sex consistent with the age or sex of other patients
with the same diagnostic codes. When the record did not include race, it
was identified as "not stated." If the dates of admission or discharge
were not given, and if they could not be obtained from the monthly sample
listing sheet transmitted by the sample hospital, a length of stay was
imputed by assigning the patient a stay characteristic of the stays of
other patients of the same age. In addition, nonresponse (about 8 percent)
for principal expected source of payment was imputed to reflect similarities
in sex and age.
SAMPLING ERRORS. --Procedures for calculating sampling errors are described
in detail in Reference 1. Estimates of standard errors for a particular
year calculated from NHDS data are available in the appendix of NHDS publi-
cations for that year. These publications are available from the address
given immediately below.
HOW TO USE THE DATA TAPE. --The NHDS records are weighted to allow inflation
to national or regional estimates. The weight applied to each record is
found in tape location 111-115. To produce an estimate of the number of
discharges, the weights for the desired records must be sunmed. To produce
an estimate for number of days of care, the weight must be multiplied by
the length of stay (tape location 101-104) and these products are summed.
Length of stay data can be obtained by using recedes already on the tape
(see items 17 and 21 in the tape layout), or by dividing days of care by
number of discharges as calculated above.
429
1979 NHDS MICRO-DATA TAPE DOCUMENTATION
QUESTIONS. --Questions concerning data in the tapes should be directed to
the Hospital Care Statistics Branch, Division of Health Care Statistics,
National Center for Health Statistics, Center Building, Room 2-43,
3700 East-West Highway, Hyattsville, Maryland 20782.
REFERENCES
National Center for Health Statistics: Development of the design
of the NCHS Hospital Discharge Survey, by W. R. Simmons. Vital and
Health Statistics. FHS Pub. No. 1000, Series 2-No. 39. Public Health
Service. Washington. U.S. Government Printing Office, Sept. 1970.
2
National Center for Health Statistics: Development and maintenance
of a national inventory of hospitals and institutions. Vital and Health
Statistics. PHS Pub. No. 1000, Series i-No. 3. Public Health Service.
Washington. U.S. Government Printing Office, Feb. 1965.
National Center for Health Statistics: International Classification
of Diseases, Ninth Revision, Clinical Modification. DHHS Pub. No.
IPHSJ 80-1260. Public Health Service. Washington. U.S. Government
Printing Office, Sept. 1980.
II. TECHNICAL DESCRIPTION OF TAPE
Data Set Name NHDS.YR1979
Number of Reels 1
Number of Recording Tracks-- 9
Density (bpi) - 1600
Language EBCDIC
Parity Odd
Record Length 200
Block Size 8000
Number of Records 215,243
III. TAPE RECORD FORMAT
This section consists of a detailed breakdown of each tape record,
providing a brief description of each item of data included in the
records. The data are arranged sequentially according to their
physical location on the tape record. Unless otherwise stated in
the Item Description, the data are derived from the abstract form.
The NMFI and the hospital interview are alternate sources of data,
while the computer generates other items.
430
1979 NHDS MICRO-DATA TAPE DOCUMENTATION
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439
1979 NHDS MICRO-DATA TAPE DOCUMENTATION
21
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1979 NHDS MICRO-DATA TAPE DOCUMENTATION 22
APPENDIX A
DEFINITIONS OF CERTAIN TERMS USED IN THIS DOCUMENT
Hospitals. --Short-stay special and general hospitals having six beds or
more for inpatient use and an average length of stay of less than 30 days.
Federal hospitals and hospital units of institutions are not included.
Bed size of hospital. --Measured by the number of beds, cribs, and pediatric
bassinets regularly maintained (set up and staffed for use) for patients;
bassinets for newborn infants are not included.
Type of ownership of hospital. --The type of organization that controls
and operates the hospital. Hospitals are grouped as follows:
Voluntary nonprofit. --Hospitals operated by a church or another
nonprofit organization.
Government. --Hospitals operated by State or local governments.
Proprietary. --Hospitals operated by individuals, partnerships, or
corporations for profit.
Patient.- -A person who is formally admitted to the inpatient service of
a short-stay hospital for observation, care, diagnosis, or treatment.
Discharge. --The formal release of a patient by a hospital, that is, the
termination of a period of hospitalization by death or by disposition to
place of residence, nursing home, or another hospital.
Discharge diagnosis. --One or more diseases or injuries (or special
conditions and examinations without sickness or tests with negative
findings) that the attending physician assigns to the medical record
of patients. (See "Medical Coding and Edit," page 5.)
Operation. --One or more surgical operations, procedures, or special
...-tments that are assigned by the physician to the medical record of
patients discharged from the inpatient service of short-stay hospitals.
(See "Medical Coding and Edit," page 5.)
Age. --Patient's age refers to age at birthday prior to admission to
the hospital inpatient service.
Race. --Patients are classified into the three groups listed in the
Tape Record Format under Race (item #19).
Geographic region and division. --Hospitals are classified by location
into one of the four geographic regions and nine geographic divisions
of the United States (items #23 and #25 in the Tape Record Format),
which correspond to those used by the U.S. Bureau of the Census.
441
1979 NHDS MICRO-DATA TAPE DOCUMENTATION
Appendix B
23
Civilian noninstitutionalized population by sex, age, and geographic region:
United States, July 1, 1979
CPopulation estijnates consistent with Series P-2S, Current Population Reports,
U.S. Bureau of the Census)
Age and Region
All Ages....
... :.-ast
North Central
South
0-14 Years
Under 1 year
1-4 years
5-14 years
Northeast
North Central
South
West
15-44 Years
15-24 years
25-34 years
35-44 years
Northeast
North Central
South
West
45-64 Years
45-54 years
55-64 years
Northeast
North Central
South
West
65 Years and Cver.
oj-74 Years
7 5 years and over
Northeast
North Central
South
West
Both Sexes
Male
Population in thousands
215,884 104,180
Female
111,704
48,232
57,515
69,941
40,193
23,138
28,021
33,486
19,533
25,094
29,493
36,456
20,660
50,092
3,279
12,362
34,451
25,563
1,679
6,319
17,564
24,530
1,600
6,043
16,887
10,416
13,433
16,766
9,477
5,324
6,862
8,540
4,836
5,092
6,570
8,226
s 4,641
98,941
48,197
50,744
40,162
34,099-.,
24,680 "~~
19,760
16,570
11,866
20,402
17,528
12,813
21,679
26,588
31,808
18,865
10,577
13,128
15,303
9,189
11,102
13,460
16,506
9,676
43,481
20,786
22,695
22,747
20,734
10,995
9,792
11,752
10,943
10,543
11,331
13,665
7,942
4,986
5,468
6,462
3,870
5,557
5,863
7,203
4,072
23,369
9,634
13,735
14,950
8,419
6,505
3,129
8,445
5,290
5,594
6,163
7,702
3,909
2,251
2,563
3,181
1,638
3,343
3,600
4,521
2,271
442
1979 NHDS MICRO-DATA TAPE DOCUMENTATION 24
Appendix C
UHDDS Class 4 Procedures Not Coded by NHDS
89.01-89.13
89.15-89.16
89.26-89.31
89.33-89.39
89.45-89.53
89.55-89.59
89.66
89.70
90.01-91.99
93.01-93.25
93.27-93.28
93.31-93.39
93.42-93.44
93.61-93.91
93.94
93.96
93.99-94.23
94.25
94.29-95.03
95.05-95.11
95.14-95.15
95.31-95.49
96.09-96.19
96.26-96.28
96.34-97.04
97.14-97,89
9/.02-99.24 n
99.26-99.59 ''
99.71-99.79
99.82-99.99
01.18-01.19
52.19
03.39
54.29
04.19
55.29
05.19
56.39
06.19
57.39
07.19
58.29
08.19
59.29
08.91-08.93
60.18
09.19
61.19
09.41-09.49
62.19
10.29
63.09
11.29
64.00
12.29
64.19
14.19
64.91
15.09
64.94
16.21
65.19
16.29
66.19
18.01
67.19
18.11
68.19
18.19
69.92
20.39
70.21
21.21
70.29
21.29
71.19
22.19
73.60
24.19
73.
91
-73.92
25.09
75.35
25.91
76.19
26.19
78.
80
-78.89
27.29
81.98
27.91
83.29
28.19 -
85.19
29.19
86.19
31.48-31.49
86.92
33.28-33.29
87,
,09
-87.12"
34.28-34.29
87.
,16
-87.17
37.29
87,
,22
-87.29
38.29
87,
.36
-87.37
40.19
87.39
41.30-41.39
87
.43
-87.49
42.29
87.69
44.19
87.79
45.19
87
.85
-87.89
45.28-45.29
87.92
48.23
87
.95
-87.99
48.29
88.09
49.21
88
.16
-88.31
49.29
88.33
49.41
88.35
50.19
88.37
51.19
88.39
443
APPENDIX E
NATIONAL HEART TRANSPLANTATION STUDY
POTENTIAL ORGAN DONOR SURVEY
GALLUP POLL
POTENTIAL ORGAN DONOR SURVEY
GALLUP POLL
1. Some people choose to donate their kidneys, hearts, livers, and other
organs upon their death to others who need organ transplant
operations. Before now have you ever heard about organ
transplantation?
(CIRCLE ONE)
YES 01
NO 02
2. The Uniform Anatomical Gifts Act permits an individual to sign a card
donating his or her organs in case of death. Have you ever heard
about or received information concerning organ donation?
(CIRCLE ONE)
YES 01
No 02 (SKIP TO Q. 5)
3. Before today, from what sources have you learned about organ
donations? (DO NOT READ, CIRCLE ALL THAT APPLY)
(CIRCLE ALL THAT APPLY)
DOCTORS OR NURSES 01
TELEVISION 02
NEWSPAPERS AND MAGAZINES 03
RADIO 04
FRIENDS 05
LECTURES 06
BROCHURES AND PAMPHLETS 07
OTHER (INCLUDES DON'T KNOW) 08
08/31/82
.
444
4. Do you currently carry an organ donor card?
(CIRCLE ONE)
YES 01 (SKIP TO Q.6)
NO 02
5. Would you, if asked, be prepared to sign and carry an organ donor card?
(CIRCLE ONE)
YES 01
NO 02
6. If you had to make the decision, would you donate the organs of a
relative who had just died?
(CIRCLE ONE)
YES 01
NO 02
7. If you were to die suddenly, do you think that your family would give
permission for the removal of any of your organs for transplantation?
(CIRCLE ONE)
YES 01
NO 02
08/31/82
445
Next, I would like to find out which, if any, of the following organs
you would be willing to donate. Would you be willing to donate...
(CIRCLE YES OR NO FOR EACH ITEM)
a.
KIDNEYS
b.
CORNEAS
c.
HEART
d.
LIVER
e.
LUNGS
f.
PANCREAS
g-
SKIN
h.
WHOLE BODY
YES
NO
01
02
01
02
01
02
01
02
01
02
01
02
01
02
01
02
9. Do you feel that if someone signs an organ donor card his or her
decision should have to be formally approved by his next-of-kin when
he dies ?
(CIRCLE ONE)
YES 01
NO 02
10. If the next-of-kin disapproves do you feel that their disapproval
should override the potential donor's wishes as expressed on any organ
donor card?
(CIRCLE ONE)
YES 01
NO 02
08/31/82
446
11. Do you feel that the next-of-kin should be allowed to donate the
organs of relatives who have recently died but have not signed an
organ donor card?
(CIRCLE ONE)
YES 01
NO 02
12. Do you feel that doctors should have the power to remove organs from
people who have recently died but have not signed an organ donor card
without consulting their next-of-kin?
(CIRCLE ONE)
YES 01
NO 02
13. Brain death is considered to occur when brain activity stops, although
it is possible to continue heartbeat and respiration by artificial
means. State laws may use brain death as the legal definition of
death and will allow the removal of organs for transplantation, such
as the heart, from persons pronounced dead on this basis. Do you feel
that brain death should be used as the legal definition of death?
(CIRCLE ONE)
YES 01
NO 02
14. Do you feel that it is all right to remove organs for transplantation
upon declaration of brain death?
(CIRCLE ONE)
YES 01
NO 02
08/31/82
447
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448
APPENDIX G
NATIONAL HEART TRANSPLANTATION STUDY
ORGAN PROCUREMENT PARTICIPATION LIST
Professor Arnold G. Diethelm, M.D.
University of Alabama Medical Center
Department of Surgery,
Division of Organ Transplantation
University Station
Birmingham, AL 35294
Ben VanderWerf, M.D., Ph.D., Medical Director
Phoenix Renal Transplant Center
1010 East McDowell Road, Suite 201
Phoenix, AZ 85006
C. F. Zukoski, M.D.
Renal Transplant Program
3601 S. 6th Avenue
Tucson, AZ 85723
W. J. Flanigan, M.D.
University of Arkansas for Medical Sciences
Renal Transplant Office, Slot 401
4301 West Markham Street
Little Rock, AR 72201
Barbara L. Schulman, R.N., Transplant Coordinator
Regional Organ Procurement Agency
of Southern California (ROPA)
1000 Veteran Avenue
Los Angeles, CA 90024
Ms. Barbara Priscoe
Risk Management
University of California
Davis Medical Center
4301 X Street #229
Sacramento, CA 95817
Susan Hopper, R.N., M.S.N.
Transplant Coordinator
University of California
Transplant Services
Moffitt Hospital, Rm. 884
Third and Parnassus
San Francisco, CA 94143
Debrah Prewit, Transplant Coordinator
2915
Renal Transplant Program
Pacific Medical Center
P. 0. Box 7999
San Francisco, CA 94120
(205) 934-5200
(602) 257-4336
(602) 792-1450, Ext. 366
or 557
(501) 661-5846
(213) 825-7651
(916) 453-2171
(415) 666-1551
(415) 563-4321, Ext.
449
Paul D. Taylor, Coordinator (303) 399-1211
University of Colorado Medical Center
Department of Surgery
4200 East 9th Avenue
Denver, CO 80262
Kristine Ridyard (203) 524-2930
Transplantation Service,
Dept. of Surgical Research
Hartford Hospital
80 Seymour Street
Hartford, CT 06115
Jon Waddell, R.N., Transplant Coordinator (202) 676-4228
George Washington University Medical Center (202) 676-2770
H.B. Burns Memorial Building, Room 813
2150 Pennsylvania Avenue N.W.
Washington, DC 20037
Clive 0. Callender, M.D. (202) 745-1444
Howard University Hospital
Transplant Center
2041 Georgia Avenue N.W.
Washington, DC 20060
Daniel G. Smith, (202) 576-1462
Organ Procurement Director (202) 576-3876
Organ Transplant Service
Department of Surgery
Walter Reed Army Medical Center
Washington, D.C. 20012
Mark Reiner, P. A., Director of Organ Procurement (904) 392-3711
University of Florida College of Medicine, JHMHC
Department of Surgery
P. 0. Box J-286
Gainesville, FL 32610
Les Olson, Director of Organ Retrieval (305) 547-6315
University of Miami
School of Medicine
Department of Surgery (R-310)
P.O. Box 016310
Miami, FL 33101
Joanne VanLooven, R.N., Transplant Coordinator (305) 896-6611
East Central Florida Transplant Program (305) 897-1501
601 E. Rollins Avenue
Orlando, FL 32803
450
James E. MacFarland, LPN
Northwest Florida Artificial Kidney Center
1717 North "E" Street, Suite 506
Pensacola, FL 32501
Jack Fortenberry, R.N., , Transplant Coordinator
Florida West Coast Organ Procurement, Inc.
1 Davis Island, Suite 401
Tampa, FL 33606
Sylvia B. Rodgers, Transplant Coordinator
Atlanta Regional Organ Procurement Agency
590 Piedmont Avenue N.E.
Atlanta, GA 30308
Mary Anne House, R.N., M.S.N. ,
Transplant Coordinator
Medical College of Georgia
Kidney Procurement Program BA-A423
Augusta, GA 30912
Joan I. Machado, R.N.
St. Francis Hospital
2230 Liliha Street
Honolulu, HI 96817
Transplant Coordinator
Dr. James S. Wolf, Chairman
Northwestern Memorial Hospital
Division of Transplantation
Wesley Pavillion, Room 446
Chicago, IL 60611
Nick A. Geroulis, Transplant Coordinator
Rush-Presbyterian-St. Luke's Medical Center
Organ Procurement and Preservation,
Department of Surgery, Room 762 Jelke
1753 West Congress Parkway
Chicago, IL 60612
Linda Szepelak, R.N., Transplant Coordinator
University of Chicago Hospitals and Clinics
Surgery Department, Box 77
950 E. 59th Street
Chicago, IL 60637
Barbara F. Prusak, R.N.
University of Illinois Medical Center
Division of Transplant Surgery
840 S. Wood Street, Room 518H
Chicago, IL 60612
(904) 433-5451
(813) 258-5661 (office)
(404) 659-5918 (hotline)
(404) 828-3893 (page)
(404) 828-2874 (office)
(808) 547-6011
(312) 649-7320
(312) 942-6242
(312) 947-6838
(312) 996-6771
(312) 996-6018
(312) 539-0183 (page)
451
Jane Swanson, R.N., Organ Procurement Coordinator
Renal Transplant Lab
Southern Illinois University School of Medicine
Memorial Medical Center
800 North Rutledge
Springfield, IL 62781
Dave Mainous, R.N., Transplant Administrator
Renal Transplant Center
UHC 430
1100 West Michigan Street
Indianapolis, IN 46223
Wm. Larry Lloyd, Transplant Coordinator
Methodist Hospital of Indiana, Inc.
Renal Department
1604 N. Capitol Avenue
Indianapolis, IN 46202
Richard M. Feeney,
University of Iowa Hospitals and Clinics
Department of Surgery
Transplantation Service
Newton Road
Iowa City, IA 52242
Tom Threlkeld, P. A., Transplant Coordinator
Division of Urology
University of Kentucky Medical Center
Lexington, KY 40536
Ken E. Richardson
ESRD Administrator
End Stage Renal Disease Program
at Jewish Hospital
217 East Chestnut Street
Louisville, KY 40202
Elaine M. Vuyosevich, R.N., M.S.,
Transplant Coordinator
Louisiana State University Medical Center
Department of Medicine
Nephrology - Room 456
1542 Tulane Avenue
New Orleans, LA 70112
Mike Vaughn, Transplant Coordinator
Tulane University Medical School
Department of Surgery
Division of Transplantation
1430 Tulane Avenue
New Orleans, LA 70112
(217) 788-3906
(317) 264-3806
(317) 924-8679 (office)
(319) 356-3585
(606) 233-6677 (office)
(502) 588-5757
(504) 568-4610
(504) 588-5386
452
Ms. Louise M. Jacobbi, Transplant Coordinator
Louisiana State University Medical Center
Department of Surgery
P. 0. Box 33932
Shreveport, LA 71130
Dave Kappus, Transplant Coordinator
Marilyn Organ Procurement Center, Inc.
GBOPPC, Box 98
22 South Greene Street
Baltimore, MD 21201
Mary Ann Greene, Transplant Coordinator
New England Organ Bank
Procurement and Preservation Division
150 South Huntington Avenue
Boston, MA 02130
Gerda H. Lipcaman, Executive Director
Organ Procurement Agency of Michigan
3374 Washtenaw Avenue
Ann Arbor, MI 48104
Mary Jane LaCombe, Transplant Coordinator
Hennepin County Medical Center
701 Park Avenue, Room 2134
Minneapolis, MN 55415
E. Jane Van Hook, R.N.
University of Minnesota
Mayo Memorial Building, Box 166
Department of Surgery
420 Delaware Street S.E.
Minneapolis, MN 55455
Sylvester Sterioff, M.D.,
Director of Transplantation
Mayo Clinic-Mayo Foundation
Surgery Department
200 First Street S.W.
Rochester, MN 55901
Richard MacMillan, R.N.,
Organ Procurement Coordinator
Department of Surgery
University of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216
(318) 226-3589
(301) 528-3626
(617) 277-8500
(313) 973-1577
(612) 347-5702 (office)
(612) 376-1906
(507) 284-4387
(601) 968-3500 (hotline)
(601) 968-5535 (office)
453
Dr. Gilbert Ross
University of Missouri
Health Sciences Center, N-509
Department of Surgery
807 Stadium Road
Columbia, MO 65212
Barbara F. Steinmetz
Midwest Organ Bank
305 West 43rd Street
Kansas City, MO 64134
Rob Linderer, Transplant Coordinator
St. Louis Regional Transplant Association
St. Louis University Hospital
1325 South Grand Boulevard
St. Louis, MO 63104
(314) 442-1734
(314) 882-8763
(816) 931-6353
(314) 771-7600, Ext. 3651
Marge N. Maeser, R.N.,
Washington University
Department of Surgery
5103 Queeny Tower
St. Louis, MO 63110
Transplant Coordinator
(314) 454-2911
Frederick Ware, M.D.
Nebraska Organ Retrieval System, Inc.
4060 Vinton Street, Suite 102
Omaha, NE 68105
David C. Johnson, M.D.
Washoe Medical Center
Hemodialysis Unit
77 Pringle Way
Reno, NV 89502
John F. Dennis, Transplant Coordinator
Southern N.J. Regional Transplant Program
Our Lady of Lourdes Hospital
1565 Haddon Avenue
Camden, NJ 08103
Joseph Treimel, R.N., Transplant Program Coordinator
Northern New Jersey Organ Procurement Program
Newark Beth Israel Medical Center
Department of Organ Transplant
201 Lyons Avenue
Newark, NJ 07112
Elissa Hepner, M.S.W., Transplant Coordinator
Kidney Transplant Service
The University of New Mexico Hospital
2211 Lomas Boulevard NE
Albuquerque, NM 87106
(402) 553-7954 (hotline)
(402) 348-3721 (office)
(702) 329-2575
(603) 428-5999
(603) 757-3840
(201) 763-1773 (hotline)
(201) 926-7262 (hospital)
(505) 277-3156
454
Frank Taft, Transplant Coordinator (518) 445-5614
Northeast New York Regional Transplant Program
Albany Medical College
47 New Scotland Avenue
Albany, NY 12208
Gift of Life Program, Lea Emmett, R.N., B.S. (212) 270-1898
S.U.N.Y.
Downstate Medical Center
450 Clarkson Avenue, Box 98
Brooklyn, NY 11203
Craig Meinking, P. A., Transplant Coordinator (716) 883-0003
Organ Procurement Agency of
Western New York
237 Linwood Avenue
Buffalo, NY 14209
Carol K. Christiansen, R.N., (516) 562-3030
Transplant Coordinator
North Shore University Hospital
400 Community Drive
Manhasset, NY 11030
Geraldine Rasmussen, Transplant Coordinator (212) 861-7370
New York Regional Transplant Program, Inc.
Two East 103rd Street
New York, NY 10029
Mary Ann Hanes, Transplant Coordinator (716) 275-2729
University of Rochester School of Medicine
Strong Memorial Hospital
601 Elmwood Avenue
Rochester, NY 14642
Corbin Peterson, P. A., Transplant Coordinator (919) 684-3118
Duke University Medical Center (beeper 1505)
P. 0. Box 3836
Durham, NC 27710
Michael Callahan, R.N., Transplant Coordinator (704) 373-2121 (hotline)
Charlotte Memorial Hospital and Medical Center
P. 0. Box 32861
Charlotte, NC 28232
Rick Hall, R.N., Transplant Coordinator (919) 757-4629
Organ Procurement Agency
East Carolina University School of Medicine
Department of Surgery-Division of Transplantation
Greenville, NC 27834
455
Ronald L. Dreffer, Transplant Coordinator
University of Cincinnati Medical Center
Department of Surgery
Division of Transplantation
Cincinnati, OH 45267
Debbie May, Public Education Coordinator
Organ Recovery Inc.
1991 Lee Road
Cleveland, OH 44118
Ronald D. Matheis
Ohio State University
Kidney Transplant Program
University Hospital, Room 480
410 West 10th Avenue
Columbus, OH 43210
Judy Messinger, Executive Director and Coordinator
Organ Procurement Agency of Northwestern Ohio
350 Holland Road, Suite E
Maumee, OH 43537
(513) 872-4156
(216) 371-8455
(614) 421-8484
(419) 893-4891
Burton J. Mattice
Miami Valley Hospital
Artificial Kidney Unit
One Wyoming Street
Dayton, OH 45409
E. Collier, R.N., Transplant Coordinator
St. Anthony Hospital
Dialysis Unit
1000 North Lee
Oklahoma City, OK 73102
Bill Harwell, Transplant Coordinator
Hillcrest Renal Disease Center
1145 South Utica Avenue, Suite 607
Tulsa, OK 74104
(513) 223-6192, Ext. 3425
(405) 272-6583
(918) 584-1351, Ext. 7994
Myrna Fletcher
Oklahoma Memorial Hospital
Department of Urology
920 Stanton L. Young Blvd.
Oklahoma City, OK 73140
Carol Lieberman
Oregon Health Sciences University
Renal Transplant L477
3181 S.W. Sam Jackson Park Road
Portland, OR 97201
(405) 271-6988
(503) 225-8153
456
Stephen M. Sammut, Executive Director (215) 543-6391
Delaware Valley Transplant Program
101 N. 33rd Street, Suite 416
Philadelphia, PA 19104
Donald W. Denny, Director of Organ Procurement (412) 624-4760
Transplant Foundation (412) 624-0579
University of Pittsburgh
954 Scaife Hall
Pittsburgh, PA 15261
Nancy Kay, Transplant Coordinator (803) 792-2164
Medical University of South Carolina
CSB Building, Room 312
171 Ashley Avenue
Charleston, SC 29425
Gary Hall, Transplant Coordinator (901) 528-5923
Mid-South Transplant Foundation, Inc.
956 Court Avenue, Suite 2G18
Memphis, TN 38163
Luke Skelley (615) 327-2247
Nashville Regional Organ Procurement Agency
1600 Hayes Street, Suite 300
Nashville, TN 37203
Michael L. Rosson, R.N., Transplant Coordinator (713) 762-2560
Southwest Organ Bank, Inc.
3606 Live Oak
Dallas, TX 75204
Ms. Lydia Torian, R.N., Transplant Coordinator (713) 792-5680
University of Texas Health Science Center (713) 792-5670
Surgery Department
6431 Fannin, Suite 6.240
Houston, TX 77030
Jane Roehl (713) 790-2201
Kidney Acquisition Department (beeper C-377)
Methodist Hospital
6565 Fannin
MS 121K
Houston, TX 77036
Ron V. Condon, Jr., Transplant Coordinator (512) 732-9612
South Texas Organ Bank, Inc.
4335 Piedras Drive West
San Antonio, TX 78228
457
Dean W. Cowan, Transplant Coordinator
Austin Diagnostic Clinic
Kidney Transplant Program
802 W. 34th Street
Austin, TX 78705
Ms. Janet McCalman
Intermountain Transplant Center
50 North Medical Drive
University of Utah College of Medicine
Salt Lake City, UT 84132
Bill Anderson, Transplant Coordinator
Virginia Organ Procurement Agency
533 Newtown Road, Suite 117
Virginia Beach, VA 23462
Ann Martin, R.N., Organ Procurement Specialist
Medical College of Virginia
Transplant Program
MCV Station, Box 499
Richmond, VA 23298
D. Rittler Strachan, R.N.,
Virginia Organ Procurement Agency
Western Virginia Division
2728 Colonial Avenue, Suite 106
Roanoke, VA 24015
Christina Bourgeois, R.N.
Organ Procurement Coordinator
Virginia Organ Procurement Agency
Shenandoah Valley Division
P. 0. Box 3198
Winchester, VA 22601
Karyn Brunner, R.N., Organ Retrieval Coordinator
Northwest Kidney Center
Organ Recovery Department
700 Broadway
Seattle, WA 98122
Robert M. Hoffman, Transplant Coordinator
University of Wisconsin Hospitals
Surgery Department (Kidney)
600 Highlands Avenue
Madison, WI 53706
(512) 459-1111, Ext. 613
(512) 458-1121 (hotline)
(801) 582-3911
(804) 627-5535
(804) 499-4484 (hospital)
(804) 786-0465 (office)
(804) 786-5321 (hotline)
(703) 345-4181
(703) 662-0222
(206) 292-2795 (office)
(206) 292-7589
(608) 263-1341
10
458
APPENDIX H
UNIFORM ANATOMICAL GIFT ACT
82H REAL PROPERTY, I'KOHATt AND TRUST JOURNAL [Vol. 15:806
UNIFORM ANATOMICAL GIFT ACT
An Act authorizing the gift of all or part of a human body after
death for specified purposes.
1 Section 1. [Definitions.]
2 (a) "Bank or storage facility" means a facility licensed, ac-
3 credited, or approved under the laws of any state for storage of
-1 human bodies or parts thereof.
5 (1)) "Decedent" means a deceased individual and includes a
6 stillborn infant or fetus.
7 (c) "Donor" means an individual who makes a gift of all or
8 part of his body.
9 (d) "Hospital" means a hospital licensed, accredited, or ap-
10 proved under the laws of any state; includes a hospital operated
11 by the United States government, a state, or a subdivision thereof,
12 although not required to be licensed under state laws.
13 (e) "Part" means organs, tissues, eyes, bones, arteries, blood,
11 other fluids and any other portions of a human body.
15 (f) "Person" means an individual, corporation, government or
10 governmental subdivision or agency, business trust, estate, trust,
17 partnership or association, or any other legal entity.
IS (g) "Physician" or "surgeon" means a physician or surgeon
19 licensed or authorized to practice under the laws of any state.
20 (h) "State" includes any state, district, commonwealth, terri-
21 tory, insular possession, and any other area subject to the legisla-
22 tive authority of the United States of America.
Comment
Subsection (f) is tnken verbatim from the Uniform Statutory Conatructioo
Act, section 2G (4). In any state that haa adopted the Uniform Act or ita equiva-
lent, this subsection will be unnecessary.
Subsection (h) is taken from section 26 (9) of the Uniform Statutory Construc-
tion Act.
1 Section 2. [Persons Who May Execute an Anatomical Gift.]
2 (a) Any individual of sound mind and 18 years of age or more
3 may give all or any part of his body for any purpose specified in
4 section 3, the gift to take effect upon death.
5 (b) Any of the following persons, in order of priority stated,
6 when persons in prior classes are not available at the time of death,
7 and in the absence of actual potine of contrary indirntinns hv the
185
459
8 decedent or actual notice of opposition. i>y.a member of the same
9 or a prior clasSj may give all or any part of the decedent's body
10 for any purpose specified in section 3:
11 (1) the spouse,
12 (2) an adult son or daughter,
13 (3) either parent,
14 (4) an adult brothenor sister,
15 (5) a guardian of the person of the decedent at the time of
16 his death,
17 (6) any other person authorized or under obligation to dis-
18 pose of the body.
19 (c) If the donee has actual notice of contrary indications by
20 the decedent or that a gift by a member of a class is opposed by a
21 member of the 6ame or a prior class, the donee shall not accept the
22 gift. The persons authorized by subsection (b) may make the gift
23 after or immediately before death.
24 (d) A gift of all or part of a body authorizes any examination
25 necessary to assure medical acceptability of the gift for the pur-
26 poses intended.
27 (e) The rights of the donee created by the gift are paramount
28 to the rights of others except as provided by Section 7 (d).
Comment
Existing state statutes differ in their respective standards establishing the donor's
competence to execute an anatomical gift.
"Competence to execute a will" is used as the standard in 10 states. "Legal
age" and sound mind is required in 5 states. "Twenty-one years and sound mind"
it the stated standard in the statutes of 10 states. In 4 states a person who is
18 years of age or older may make the gift, and in 6 states "any person" may
do so. One state requires 21 years accompanied by a certificate of a physician
that the donor is "of sound mind and not under the influence of narcotic drugs."
To minimize confusion there is merit in having a uniform provision throughout
the country. Also it is desirable to enlarge the class of possible donors as much
as possible. Subsection (a) of Section 2, providing that any person of sound
mind and 18 years or more of age may execute a gift, will afford both nation-
wide uniformity and a desirable enlargement of the class of donors. Persons 18
years of age or more are of sufficient maturity to make the required decisions
md the Uniform Act takes advantage of this fact.
Subsection (b) spells out the right of survivors to make the gift. Taking into
account the very limited time available following death for the successful re-
moval of such critical tissues as the kidney, the liver, and the heart, it seems
desirable to eliminate all possible question by specifically stating the rights of
and the priorities among the survivors.
Also, Section 2 (b) provides for the effect of indicated objections by the
decedent, and differences of view among the survivors. Finally it authorizes the
survivors to execute the necessary documents even prior to death. In view of
the fact that persons under 18 years of age are excluded from subsection (a),
186
460
830 KLAt. PROPERTY. PKOBAIt Ar»K • «v^>, . j
it ia especially desirnble to cover with care the status of survivors, so younger
decedents may be included.
Subsection (d) ia udded at the suggestion of members of the medical profession
who regard a post mortem examination, to the extent necessary to ascertain
freedom from disease that might cause injury to the new host for transplanted
parts, as essential to good medical practice.
Subsection (e) recognizes and gives legal effect to the right of the individual
to dispose of bis own body without subsequent veto by others.
1 Section 3. [Persons Who May Become Donees; Purposes for
2 Which Anatomical Gifts May be Made.} The following persons
3 may become donees of gifts of bodies or parts thereof for the pur-
4 poses stated:
5 (1) any hospital, surgeon, or physician, for medical or dental
6 education, research, advancement of medical or dental science,
7 therapy, or transplantation; or
S (2) any accredited medical or dental school, college or uni-
9 versity for education, research, advancement of medical or
10 dental science, or therapy; or
1 1 (3) any bank or storage facility, for medical or dental educa-
12 tion, research, advancement of medical or dental science, ther-
13 upy, or transplantation; or
14 (4) any specified individual for therapy or transplantation
15 needed by him.
Comment
Existing state statutes reveal great diversity of provisions concerning possible
donees and the purposes for which anatomical gifts may be made.
As to donees, the lists include licensed hospitals, storage banks, teaching
institutions, universities, colleges, medical schools, stale public health and anatomy
boards, and institutions approved by the state department of health. Some of
the statutes are detailed and comprehensive. Others are limited, brief, and
general. A few do not seek in any way to name or limit the donees. The Uni-
form Act attempts to achieve a maximum of clarity and precision by carefully
naming the permissible donees.
The statutes in a few states specify that no donor shall ask compensation and
no donee shall receive it. Several statutes provide that 6torage banks shall be
non-profit organizations. On the other hand, most of the states have chosen
not to deal with this question. The Uniform Act follows the latter course ia
litis regard.
As to purposes, again there is great diversity among the statutes. The list
of purposes includes teaching, research, advancement of medical science, therapy,
transplantation, rehabilitation, and scientific uses. Again some of the statutes are
detailed, and others are brief and general. A few statutes contain no limitation
whatsoever— merely naming the donees, thus assuring that gifts will not be made
to uudesirable persons or organizations, and then they are inclusive in naming
the purposes in broad terms, thus assuring flexibility. The Uniform Act follows
this course.
187
461
1 Section 4. [Manner of Executing Anatomical Gifts.]
2 (a) A gift of all or part of the body under Section 2 (a) may be
3 made by will. The gift becomes effective upon the death of the
4 testator without waiting for probate. If the will is not probated,
5 or if it is declared invalid for testamentary purposes, the gift, to
6 the extent that it has been acted upon in good faith, is nevertheless
7 valid and effective.
8 (b) A gift of all or part of the body under Section 2 (a) may
9 also be made by document other than a will. The gift becomes
10 effective upon the death of the donor. The document, which may
11 be a card designed to be carried on the person, must be signed by
12 the donor(m the presence of 2 witnesses who must sign the docu-
13 ment in his presence). If the donor cannot sign, the document may
14 be signed for him at his direction and in his presence in the pres-
15 ence of 2 witnesses who must sign the document in his presence.
16 Delivery of the document of gift during the donor's lifetime is not
17 necessary to make the gift valid.
18 (c) The gift may be made to a specified donee or without
19 specifying a donee. If the latter, the gift may be accepted by the
20 attending physician as donee upon or following death. If the gift
21 is made to a specified donee who is not available at the time and
22 place of death, the attending physician upon or following death,
23 in the absence of any expressed indication that the donor desired
24 otherwise, may accept the gift as donee. The physician who
25 becomes a donee under this subsection shall not participate in the
26 procedures for removing or transplanting a part.
27 (d) Notwithstanding Section 7 (b), the donor may designate
28 in his will, card, or other document of gift the surgeon or physician
29 to carry out the appropriate procedures. In the absence of a desig-
30 nation or if the designee is not available, the donee or other person
31 authorized to accept the gift may employ or authorize any sur-
32 geon or physician for the purpose.
33 (e) Any gift by a person designated in Section 2 (b) shall
34 be made by a document signed by him or made by his telegraphic,
35 recorded telephonic, or other recorded message.
Comment
Most existing state statutes authorizing anatomical gifts provide for doing so
either by will or by other document in writing. The number of witnesses varies
from state to state, but the majority require two witnesses. The Uniform Act
requires two witnesses to validate a gift during the donor's lifetime, but witnesses
are relatively unnecessary in the case of a gift by next of kin since they are
available in person. Hence, none are required in 6uch cases. To facilitate avail-
ability of evidence of the gift, a card may be carried on the person, a practice
commonly and successfully followed in connection with gifts of eyes. This is
188
462
832 RKAL PROPERTY, PROBATE AND TRUST JOURNAL IVOI. 1D:8U0
an important provision, for we are a peripatetic people and the advantages of
a card carried on the person 6tating the donor's intention to donate is apparent.
Also important are the provisions of subsection (c) that permit the attending
physician upon or following death to be the donee when no donee is named or
when the named donee is not available. The donee physician cannot participate
personally in removing or transplanting a part, but he can, of course, make a
further gift to another person for any authorized purpose.
Attention should also be called to subsection (e) authorizing the next of kin
to make gifts by "telegraphic, recorded telephonic, or other recorded message."
Frequently the next of kin are far away, and this provision, not found in any
existing statute, has the advantage of expediting the procedures where time for
effective action is short.
As the Uniform Act becomes widely accepted it will prove helpful if the forms
by which gifts are made are similar in each of the participating states. Such forms
should be as simple and understandable as possible. The following forms are
suggested for the purpose:
Anatomical Gift by a Living Donor
I am of sound mind and 18 years or more of age.
I hereby make this anatomical gift to take effect upon my death. The marks
in (he appropriate squares and words filled into the blanks below indicate my
desires. '
I give: G >ny body; □ any needed organs or parts; □ the following organs
or parts ;
To the following person (or institution) : □ the physician in attendance at
my death; Q the hospital in which I die; □ the following named physician,
hospital, storage bank or other medical institution ,
; □ the following individual for treatment
for the following purposes: □ any purpose authorized by law; □ transplanta-
tion; D therapy; □ research; □ medical education.
Dated City and State
Signed by the Donor in the
presence of the following
who sign as witnesses: Signature of Donor
Witness Address of Donor
AVituess
Anatomical Gift by Next of Kin
or Other Authorized Penon
I hereby make this anatomical gift of or from the body of_
who died on at the
in
. The
marks in the appropriate squares and the words filled into the blanks below
indicate my relationship to the deceased and my desires respecting the gift.
I am the surviving: n spouse; □ adult son or daughter; n parent; □ adult
brother or sister; Q guardian; Q , authorized to dispose
of the body;
189
463
HllllLi IJUUj
I give □ the body of deceased; Q any needed organs or parts; □ the following
organs or parU :
To the following person (or institution)
(insert the name of a physician, hospital, research or educational institution,
atoruge bank, or individual),
for the following purposes: Q any purpose authorized by law; Q trans-
plantation; □ therapy; Q research; Q medical education.
Dated City and State
Signature of Survivor
Address of Survivor
1 Section 5. [Delivery of Document of Gift.] If the gift is made
2 by the donor to a specified donee, the will, card, or other document,
3 or an executed copy thereof, may be delivered to the donee to
4 expedite the appropriate procedures immediately after death. De-
5 livery is not necessary to the validity of the gift. The will, card,
6 or other document, or an executed copy thereof, may be deposited
7 in any hospital, bank or storage facility or registry office that
8 accepts it for safekeeping or for facilitation of procedures after
9 death. On request of any interested party upon or after the donor's
10 death, the person in possession shall produce the document for
11 examination.
Comment
Some of the statutes make rather formal mandatory provisions for filing of
documents of gift. Thus in two states the gift must be "filed for record in the
office of the judge of probate." In another the document must be filed either
before death or within 60 hours after death with the State Department of Health.
In another the instrument must be filed for record "in the office of the clerk of
the district court of the parish wherein the person making the gift resides." In
still another the instrument must be filed in the probate court. In two states it
is provided that the instrument shall be delivered by the donor to the donee.
On the other hand, in the great majority of the states, no provision is made for
filing, recording, or delivery to the donee. The gift is by implication effective
without such formality. Section 5 of the Uniform Act follows the majority
permissive practice, but includes permissive filing provisions to expedite post-
mortem procedures.
1 Section 6. [Amendment or Revocation of the Gift.]
2 (a) If the will, card, or other document or executed copy
3 thereof, has been delivered to a specified donee, the donor may
4 amend or revoke the gift by:
5 (1) the execution and delivery to the donee of a signed
6 statement, or
190
464
'. 7 (2) an oral statement made in the presence of 2 persona
8 and communicated to the donee, or
9 (3) a statement during a terminal illness or injury addressed
10 to an attending physician and communicated to the donee, or
11 (4) a signed card or document found on his person or in
12 his effects.
13 (b) Any document of gift which has not been delivered to the
14 donee may be revoked by the donor in the manner set out in
15 subsection (a), or by destruction, cancellation, or mutilation of
16 the document and all executed copies thereof.
17 (c) Any gift made by a will may also be amended or revoked
IS in the manner provided for amendment or revocation of wills, or
19 as provided in subsection (a).
Comment
In about one half of the states no provision is made for revocation. However,
in the interest of currying out the ultimate desires of the donor, there is good
reason for facilitating revocation. Accordingly, about half of the states make
allirmative provisions concerning the matter. Usually it is provided that revo-
cation may be accomplished by executing a "like instrument" filed in the manner
provided for the instrument of gift and delivered to the donee. In a few states
revocation is accomplished by demanding return of the document of gift. There
is merit in making revocation both simple and easy to accomplish. Prospective
donors are more likely to look with favor on making anatomical gifts if they
realize that revocation is readily possible. The Uniform Act makes careful and
complete provision for revocation under various contingencies. However, if a
donor has deposited an executed copy of an undelivered document of gift as
authorized by Section 5, and if the donor desires to revoke the gift, he must
see to it that the executed copy which has been deposited is destroyed.
1 Section 7. [Rights and Duties at Death.]
2 (a) The donee may accept or reject the gift. If the donee ac-
3 cepts a gift of the entire body, he may, subject to the terms of
4 the gift, authorize embalming and the use of the body in funeral
5 services. If the gift is of a part of the body, the donee, upon the
6 death of the donor and prior to embalming, 6hall cause the part
7 to be removed without unnecessary mutilation. After removal
S of the part, custody of the remainder of the body vests in the
9 surviving spouse, next of kin, or other persons under obligation
10 to dispose of the body.
11 (b) The time of death shall be determined by a physician who
12 tends the donor at his death, or, if none, the physician who certi-
13 fies the death. The physician shall not participate in the proce-
14 dures for removing or transplanting a part.
15 (c) A person who acts in good faith in accord with the terms
16 of this Act or with the anatomical gift laws of another state
191
465
17 [or a foreign country] is not liable for damages in any civil action
18 or subject to prosecution in any criminal proceeding for his act.
19 (d) The provisions of this Act are subject to the laws of this
20 state prescribing powers and duties with respect to autopsies.
Comment
SectioD 7 contains several important provisions. The donee may of course,
reject the gift if he deems it best to do so. If he accepts the gift, all possible
provision is made for taking account of the interests of the survivors in dignified
memorial ceremonies. Also if the donee accepts the gift, absolute ownership vesta
in him. He may, if he so desires, transfer his ownership to another person,
whether the gift be of the whole body or merely a part. He may "cause the
part to be removed" either by himself or by another person. The only restric-
tions are that the part must be removed without mutilation and the remainder
of the body vests in the next of kin.
Subsection (b) leaves the determination of the time of death to the attending
or certifying physician. No attempt is made to define the uncertain point in
time when life terminates. This point is not subject to clear cut definition and
medical authorities are currently working toward a consensus on the matter.
Modern methods of cardiac pacing, artificial respiration, artificial blood circula-
tion and cardiac stimulation can continue certain bodily systems and metabolism
far beyond spontaneous limits. The real question is when have irreversible
changes taken place that preclude return to normal brain activity and self
sustaining bodily functions. No reasonable statutory definition is possible. The
answer depends upon many variables, differing from case to case. Reliance must
be placed upon the judgment of the physician in attendance. The Uniform Act
so provides. ^
However, because time is short following death for a transplant to be successful,
the transplant team needs to remove the critical organ as soon as possible. Hence
there is a possible conflict of interest between the attending physician and the
transplant team, and accordingly subsection (b) excludes the attending physician
from any part in the transplant procedures. Such a provision isolates the conflict
of interest and is eminently desirable. However, the language of the provision
does not prevent the donor's attending physician from communicating with the
transplant team or other relevant donees. This communication is essential to
permit the transfer of important knowledge concerning the donor, for example,
the nature of the disease processes affecting the donor or the results of studies
carried out for tissue matching and other immunological data.
Subsection (d) is necessary to preclude the frustration of the important medical
examiners' duties in cases of death by suspected crime or violence. However,
since such cases often can provide transplants of value to living persons, it
may prove desirable in many if not most states to reexamine and amend, the
medical examiner statutes to authorize and direct medical examiners to expedite
their autopsy procedures in cases in which the public interest will not suffer.
The entire section 7 merits genuinely liberal interpretation to effectuate the
purpose and intent of the Uniform Act, that is, to encourage and facilitate the
important and ever increasing need for human tissue and organs for medical
research, education and therapy, including transplantation.
1 Section 8. [Uniformity of Interpretation.] This Act shall be
192
466
83(> KfcAL HKOKtHTV, PKOBMt ainu i«x^. j.
2 to construed as to effectuate its general purpose to make uniform
3 the law of those states which enact it.
1 Suction 9. [Short Title.] This Act may be cited as the Uniform
2 Anatomical Gift Act.
1 Section 10. [Repeal.] The following acts and parts of acts
2 are repealed:
3 (1)
4 (2)
5 (3)
1 Section 11. [Time of Taking Effect.] This Act shall take
2 effect ....
Note:
By action of the commissioners at their Annual Conference in
August, 1980 the following amendments were made:
1. Brackets [ ] were added to Section 4 (b) in lines 12 and 13 as
indicated.
2. Existing lines 13 thru 16 of Comments on page 189 were de-
leted.
3. The following paragraphs were added to Comments on Page 189
after line 12:
Secretaries of State and all state officials responsible for drivers
licenses should be encouraged to print on the back of drivers license
language permitting the individual to make a gift of all or specific
parts of his or her body on death pursuant to the law of that state.
(Sample forms for use on drivers license currently in use in
Wisconsin and Michigan were added to the Comments.)
More comprehensive forms for the anatomical gift by a living
donor or by the next of kin or other authorized person are as
follows:
467
PROPOSED UNIFORM ACTS FOR A
STATUTORY WILL, STATUTORY TRUST AND
STATUTORY SHORT FORM CLAUSES*
Introduction
In many parts of the country increasing consideration is being given to
the concept that legislation can aid the legal profession and the public by
providing the means to meet the estate planning needs of many persons with
small to medium sized estates by simple, short, economical and competent
instruments. There is widespread recognition that the estate planning pro-
cess has become too complicated and too costly for many persons. There is
also too much risk of error for many lawyers who, although called upon to
provide the services, are often not experts in the drafting of wills and trusts.
And the lawyer's task is becoming more and more risky under the increasing
hazards imposed by tax legislation and malpractice litigation.
This committee is convinced that appropriate legislation can make a
constructive contribution to a solution. Our committee has attempted to
review relevant statutes that have been enacted and proposals made in states
where consideration has reached that stage. We have solicited and had the
benefit of comments and drafts from a number of individuals.
With this report we submit drafts of three proposed uniform acts: (1)
Uniform Statutory Will Act,1 (2) Uniform Statutory Custodianship Trusts
Act* and (3) Uniform Short Form Clauses for Wills and Trusts Act.' The acts
have been drafted for consideration either as a package or as separate acts. I f
considered as separate acts, it must be borne in mind that the first two acts
draw on provisions provided in the third. With a view to adoption as uniform
acts the attempt has been to make them compatible with the language and
format of the Uniform Probate Code, treating the Uniform Probate Code,
although not enacted generally, as providing hopefully a kind of common
language.
All of the acts employ the legal advice of a statutory form of incorpora-
tion by reference. They enable a settlor or testator.to adopt statutory provi-
sions by a simple form of incorporation by reference.
1. Uniform Statutory Will Act
This is a proposal for what many have come to refer to as a "statutory
will". However, the proposed act would not adopt a will form. There is
widespread apprehension that the adoption of a statutory will form, which
would lend itself to use without legal advice by purchase from a stationer, is
likely to encourage dangerous misuse. This risk cannot be completely ex-
cluded under the proposed statute, nor even under present law without any
♦Report of Committee on Fiduciary Services for Small Estates and Conservatorships,
Probate and Trust Division.
'Sit Appendix A infra.
'•S'« Appendix B infra.
*See Appendix C infra.
837
468
APPENDIX I
SURVEY OF ORGAN DONATION PROCEDURES
STATE:
I.D.#:
la. Could you provide us with a copy of your state's
Anatomical Gift Act? YES NO
lb. IF NO, could you provide us with the citation to
the statute? YES NO
lc. IF NO, who would you suggest contacting for the
statute citation?
2a. Does your state have a legal definition of death?
2b. IF YES, does your state statute include brain
death in its definition?
2c. IF YES, could you provide us with the citation
or a copy of the statute?
3. Is brain death generally used as the standard
for death?
4. Are specific criteria used to determine brain
death? (for example, Harvard criteria)
5. Who generally makes the determination of death?
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
6. Are there any other persons legally capable of
determining death? YES NO
PHYSICIAN
OTHER HOSPITAL PERSONNEL
CORONER
MEDICAL EXAMINER
UNDERTAKER
POLICE, SHERIFF
7. Does the state have a provision on the driver's
license for organ donation? YES NO
8. Are organ donor cards distributed independently
of the driver's license? YES NO
2/25/83
469
IF YES, how are the cards distributed?
HOSPITALS
MEDIA
NATIONAL KIDNEY FOUNDATION
LIONS EYE BANK
PUBLIC EDUCATION, SEMINARS
Does your program provide education concerning
the awareness of organ donation and its
procedures to
THE GENERAL PUBLIC? YES NO
HOSPITAL PERSONNEL? YES NO
LAW ENFORCEMENT PERSONNEL? YES NO
DESCRIBE
How is it determined if a potential organ donor
is carrying a card?
For example, what action would police take at the scene
of an accident to identify a potential donor?
2/25/83
470
lie. What action would medical personnel take to identify
a potential donor, either an accident victim or a brain
dead patient?
12a. If a card is not found, would next-of-kin be consulted
concerning organ donation? YES N0
12b. IF YES, who generally would approach the family?
13a. If a card is found, is formal consent from
next-of-kin also required?
13b. If a signed donor card is legally sufficient for
removal of organs, why is consent required?
YES NO
14. Is there any way of finding out how many people
carry organ donor cards? YES N0
DESCRIBE: .
NAME:
2/25/83
471
Special Communications
Health Care Technology and the Inevitability
of Resource Allocation and Rationing Decisions
Part I
Roger W Evans. PhD
• Increasingly, it is recognized that resources available to meet health
care needs are limited. Recently, this has been evidenced by reductions in
federally funded health care programs and the leveling off of research funds
made available to the National Institutes of Health. The problem of severely
constrained resources is likely to become more acute, given new medical
technology and the high cost of medical care. It is now apparent that both
resource allocation and resource-rationing decisions will become inevitable,
since not all persons with catastrophic or complicated medical conditions
will be able to benefit from medical technology. While the careful assess-
ment of health care technology can conceivably increase the efficiency of
the health care delivery system, the methods by which allocation and
rationing decisions are made must be improved. In doing so, it will ultimately
be essential for this society to come to grips with life and death issues in a
manner to which it is not accustomed.
[JAMA 1983;249:2047-2053)
DISCUSSIONS regarding the high
cost of medical care in increasing
numbers now include commentaries
on the possibility that the resources
available for medical care must be
allocated across medical care pro-
grams. While in the past, resources
available for the medical needs of the
See also pp 1973 and 2073.
nation have at least been perceived as
unlimited, the appearance of numer-
ous large and small medical technolo-
gies and their indiscriminate use
among some physicians has thrust
resource allocation decisions into the
From the Health and Population Study Center.
Battelle Human Affairs Research Centers. Seattle
Reprint requests to Battelle Human Artairs
Research Centers. 4000 NE 41sl St. PO Box
C 5395. Seattle. WA 98105 (Or Evans)
JAMA. April 15. 1983— Vol 249. No 15
forefront.' It is questionable whether
it will be possible, in the future, to
redistribute to medical programs re-
sources available for other purposes.
For examnle, resources earmarked for
defense could be reallocated to meet
health care needs. Meanwhile, it is
now obvious that the health care of
the nation is being jeopardized in at
least two ways, both of which have
implications for resource allocation.
First, resources available to health
care programs for the needy and
disadvantaged have been threatened
by budget cuts or have already been
reduced substantially. Second, funds
available for health-related research
are being subjected to budgetary
reductions.
These cuts also may affect both
public and private insurance pro-
grams These actions have heralded a
renewed concern over which groups of
beneficiaries are likely to be adverse-
ly affected.2 For example, it is possi-
ble that resource limitations and ad
hoc rationing svstems could threaten
the benefits currently derived
through Medicare for patients with
end-staqe renal disease (ESRDl and
various categories of Medicaid benefi-
ciaries. Accomoanying these develop-
ments have been decisions by private
insurers to revise coverage policies.
Recently, some major insurers have
begun to consider the possibility of
limiting coverage to only those situa-
tions in which a physician providing
treatment has performed a given pro-
cedure, such as coronary artery
bypass surgery, a specified number of
times. Policy initiatives such as this
certainly raise questions about how
persons with catastrophic illnesses
will be treated in the future. Will
medical care be regionalized or will
the current, relatively fragmented
delivery system remain in place?"
In past months there has also been
a substantial reduction in funds made
available for health-related research.
Iglehart,' in a review of the status of
the National Institutes of Health
(NIH), concluded that "the NIH
seems destined to face bleaker real
budgets in fiscal 1983 and beyond."
Thus, biomedical research is being
given a lower priority, and, conse-
quently, it is reasonable to expect
that in the long run, the health of the
population will be adversely affected.
For example, it is becoming increas-
ingly difficult to earmark sufficient
Health Care Technology — Evans 2047
Reprinted from the Journal ot the American Medical Association
April 15. 1983. Volume 249
Copyright 1983, American Medical Association
472
resources for clinical trials, one of the
major methods by which the efficacy
and safety of new technological inno-
vations are assessed. *~u
A picture is now beginning to
emerge in which, in the future,
resource constraints are likely to
make allocation decisions inevitable."
Consequently, the tasks of both the
clinician and policymaker are likely
to become more difficult. For exam-
ple, in the absence of formal resource
allocation rules and the failure to test
new health technology adequately
and to assess its broader social impli-
cations completely, clinicians to an
increasing degree find themselves
being forced to confront problems
that traditionally have been reserved
for biomedical ethicists.""" Unfortu-
nately, clinicians are often ill pre-
pared to deal with complex bioethical
issues. Few clinicians have previously
been asked to participate proactively
in the allocation, let alone the ration-
ing, of health care resources. Many
would argue that, in principle, this
activity represents a conflict of inter-
est and is contrary to the Hippocratic
oath.
Policymakers, perhaps surprising-
ly, seem to be equally inept at resolv-
ing ethical dilemmas. As described by
myself and co-workers,1" this was par-
ticularly true of the End-Stage Renal
Disease Program, in which it was
decided that in a country where
resources appeared almost limitless,
the ethical and moral dilemma of
selecting patients for treatment,
based on a perceived need to limit
treatment, was resolved rather easily
by making additional resources avail-
able to treat people with ESRD. In
describing the process by which Medi-
care benefits were extended to ESRD
patients, my co-workers and I con-
cluded the following
The federal government appears to have
been more concerned with ridding itself of
the moral dilemma of indirectly deciding
who could live and who would die in a
country of almost unlimited resources. The
easiest way to eradicate this problem was
to treat everyone equally by making
everyone eligible for the same benefits.
Today, it is now apparent that this
decision has only staved off the inevi-
table—deciding which patients
should be treated under public and
private insurance programs. The
prospect that such decisions may
become inevitable raises a number of
important medical, social, ethical,
Table
1. — Life Expectancy at Birth According to Race and Sex, United States
Selected Years From 1900 Through 1978'
Tata
,1'
Whits, yr
All Other, yrt
Both Sexes
H
F
Both Sexes
M
F
Both Sexes
M
F
1900*
1950
1960
1970S
1975§
1976S
1977S
47 3
46.3
48 3
47 6
466
487
330
325
335
88.2
65.6
71.1
69.1
86 5
72.2
808
59. 1
62.9
66.3
69 7
666
73 1
706
67 4
74.1
83.6
61.1
70.8
67 1
74.7
71.7
680
75.6
65 3
61.3
69.4
723
725
68 7
765
73 2
69.4
77 2
67.9
63.6
72.8
69.0
76.7
73.5
69.7
77.3
683
64 1
72.S
73.2
69.3
77 1
77 2
738
700
777
688
646
73.1
1978$
733
69 5
74.0
702
778
692
65.0
736
•Dsta from Department ot Health and Human Services *°
tFor 1900 through 1902. data for the "all other"" category were lor blacks only
♦ Death registration area only The death registration area increased from ten states, and the t
Columbia in 1900 to the coterminous United Ststes in 1933.
§Excludes deaths of nonresidents in the United Ststes.
legal, and economic questions. To the
surprise and chagrin of many, such
decisions are not completely foreign
to the medical profession.""" Prob-
lems of medical triage and the treat-
ment of patients in intensive care
units (including neonatal intensive
care) and other "high-cost" users
of medical care raise similar ques-
tions."""
LIFE EXPECTANCY,
CHRONICITY, DISABILITY,
MEDICAL TECHNOLOGY,
AND MEDICAL CARE COSTS
The reason that bioethical issues
have emerged among the more pre-
dominant issues in medicine today
becomes clear when one considers the
increased prevalence of chronic dis-
ease, the changing age distribution of
the population, notable increases in
life expectancy, the increased preva-
lence of disability, the introduction
and widespread availability of new
medical technology, and the high cost
of medical care. The interrelation-
ships among these are obvious. For
example, the longer people live, the
greater the likelihood that they will
exhibit chronic disease, have subse-
quent disability, make use of new and
expensive medical technology, and,
ultimately, fall into the category of
high-cost users of medical care.14"18
Life Expectancy
The percentage of persons older
than 65 years has steadily risen in all
industrialized countries during the
past century." While the proportion
of elderly persons in the United
States has doubled since 1900, their
numbers have increased sevenfold.
Today, the life expectancy of males,
regardless of race, is approximately
2048 JAMA. April 15, 1983— Vol 249. No. 15
70 years and for females is 77 years."
The average life expectancy for both
groups is about 71 years. Overall,
males are expected to outlive their
earlier (1900) counterparts by 22
years, and females, their counterparts
by 29 years (Table 1). While the
longevity of nonwhites lags behind
whites, the gains achieved by non-
whites have been even more dramatic
as minority life expectancy in this
country has doubled.
The composition of the population
is also changing. In 1950, 12.3 million
persons in the United States, or 8.1%
of the total population, were older
than 65 years. By 1960, this group had
grown to 16.6 million persons, or
9.2%. The number reached 23.5 mil-
lion in 1977, an increase of 91.1%
from 1950, and this figure repre-
sented 10.9% of the total population.
It is now projected that the number of
persons older than 65 years will be
31.8 million by the year 2000-12.2%
of the total population and a 157%
increase in 50 years." As the popula-
tion ages, chronic disease and disabil-
ity are becoming increasingly visible
problems. Chronic rather than acute
diseases are now the most prevalent
causes of death in industrial socie-
ties."""
Chronic Disease and Disability
Since the early 1900s, there has
been a substantial decline in those
infectious diseases that have proved
to be so intractable in past years."
Heart attack, stroke, cancer, and leu-
kemia are but a few of those retro-
gressive chronic diseases, often of
slow insidious onset, that have re-
placed infections, viruses, and tuber-
cular fatalities in the United States.
Given current available data
Hearth Care Technology— Evans
473
Table 2 — Distribution ot Persons With Limitation of Activity Because of Chronic Conditions,
Age and Degree of Limitation. United States. 1978'
According to
Age Of
Both Sexes,
y
No
of Persons, In Thousands
%
Total
Population
With Activity
Limitation (In
Major Activity)
With no
Activity
Limitation
Total
Population
With
Activity
Limitation
Limitation
In Major
Activity
With no
Activity
Limitation
All ages
<17
213.628
30,306(22.598)
183.523
1000
142
10 6
656
59.012
2.309(1.178)
56.703
1000
39
20
96 1
17-44
68.627
7.501(4.821)
81.126
1000
85
52
91 5
45-64
43.403
10.244(8.083)
39.159
100.0
23.6
186
76.4
265
22.788
10,252(8.736)
12.535
100 0
45 0
38 3
550
'Data from Givens
..
sources, it is difficult to estimate the
true prevalence of chronic disease.
Few population-based epidemiologic
studies have been undertaken to esti-
mate explicitly the prevalence of all
chronic diseases." The Framingham
Heart Study represents but one exem-
plary population-based epidemiologic
study of cardiovascular disease. Re-
sults of this study have shown the
now apparent decline in the preva-
lence of cardiovascular disease.""
Other statistics on chronic disease
that have been published by the
National Center for Health Statistics
are based on self-reported illness and
disability in the Health Interview
Study. These reports indicate that in
the early years of life, only about six
of 1,000 persons endure chronic condi-
tions. During young adulthood (age 25
or so), the rate increases to 35, and by
the fourth decade that figure has
almost tripled to 100 persons of every
1,000. By age 65, this number has
again doubled and then doubled yet
another time after age 75, until
almost 90% of all persons older than
90 years live with a chronic illness."
Again ignoring the age factor, it has
at times been estimated that approxi-
mately 50% of the civilian population,
excluding residents in institutions,
have one chronic condition or more."
As for the number of chronic condi-
tions per person, one study has shown
this to be 2.2."
It is currently estimated that 80%
of health care resources in the United
States, including facilities, services,
and biomedical research, are now
devoted to chronic disease." During
1978, an estimated 10.3 million per-
sons, or 45%, of the civilian popula-
tion aged 65 years and older not
residing in institutions were reported
in health interviews to have some
degree of activity limitation caused
by chronic disease or impairment
(Table 2)." Of these 10.3 million per-
sons, fully 85.2% indicated that they
were limited in or unable to carry on
major activities, affecting their abili-
ty to work or manage a household.*"
The remainder were limited but not
in major activity.
Ignoring the age factor, 30 million
Americans (14% of the total popula-
tion) were reported to have dysfunc-
tion caused by chronic diseases, and,
of these, 23 million, or 74.6%, were
limited in or unable to carry on major
life activities, affecting their ability
to work, manage a household, or
attend school."
Medical Technology
Over the years, medical technology
has been most successful in dealing
with infectious diseases. Thomas,"10
in his analysis of technology, notes
that much of the technology germane
to the treatment of infectious dis-
eases "comes from a genuine under-
standing of disease mechanisms, and
when it becomes available, it is rela-
tively inexpensive, relatively simple,
and relatively easy to deliver." This
technology is exemplified by modern
methods for immunization against
diphtheria, pertussis, and the child-
hood virus diseases and the contem-
porary use of antibiotics and chemo-
therapy for bacterial infections."
Other examples cited by Thomas'0
include the treatment of endocrino-
logic disorders with appropriate hor-
mones, the prevention of hemolytic
disease of the newborn, and the treat-
ment and prevention of various nutri-
tional disorders.
Major technological advances, how-
ever, have been made specifically for
treating incurable chronic diseases,
many of which have varying implica-
tions for the level of functional ability
patients are able to regain. Since
many of these interventions do not
cure disease, they are frequently
referred to as "halfway technolo-
gies,'"0" and the extent to which a
patient is able to cope and regain
maximum function becomes all im-
portant. As described by Crane,"
technological changes have affected
the very character of illness, permit-
ting the physician to have greater
control over the process of dying and
the timing of death. She also notes
that in less obvious ways, improve-
ments in medical technology have
produced increasing levels of disabili-
ty in western society." Moreover,
technology has permitted the survival
of more or less severely disabled
persons such as diabetics and infants
with myelomeningocele who would
otherwise have died.
It is now estimated that each year,
hundreds— perhaps thousands— of
new technologies enter the medical
care system. These include drugs,
procedures, devices, and instrumenta-
tion, all constituting preventative,
diagnostic, and therapeutic tools."
Many of these technologies have
undoubtedly contributed to the sub-
stantial improvement in the health
status of the American people. Also,
relief of pain, amelioration of symp-
toms, and rehabilitation now have
become possible for many patients
with diseases that cannot be success-
fully prevented or treated." The bene-
fits of medical technology, in some
instances, have been found to be more
apparent than real." For example,
various inefficacious procedures have
been practiced and then abandoned in
this country. These include gastric
freezing for peptic ulcer, colectomy
for epilepsy, hypogastric artery liga-
tion for pelvic hemorrhage, sympa-
thectomy for asthma, internal mam-
mary artery ligation for coronary
artery disease, adrenalectomy for
essential hypertension, and wiring for
aortic aneurysm." ""
While efficacy and safety (that is,
medical technology's medical benefits
JAMA. April 15. 1983— Vol 249. No 15
Health Care Technology— Evans 2049 ,
474
and risks) have traditionally been the
primary focus of health technology
assessment,51 •"J"2 attention has begun
to focus on other aspects of health
care technology."" For example, on
June 12, 1980, Patricia Roberts Har-
ris, then secretary of the Department
of Health and Human Services,
announced that new health technolo-
gies must be evaluated not only on the
basis of their medical efficacy and
safety but also on the basis of their
"social consequences" before "financ-
ing their wide distribution."" As
noted by Knox," the approach being
suggested by Harris was even more
comprehensive than that used by,
for example, the Environmental Pro-
tection Agency in dealing with
pesticides, the Food and Drug Admin-
istration in its treatment of pharma-
ceuticals, and the Occupational Safe-
ty and Health Administration's
approach to carcinogens in the work
place.*"* New health technology was
to be evaluated concerning its cost-
effectiveness, cost-benefit ratios,
ethical implications, and "long-term
effects on society." The all-encom-
passing intent of technology assess-
ment has been characterized by Ban-
ta and Benney" as follows:
Technology assessment is seen as a com-
prehensive form of policy research that
examines short- and long-term social con-
sequences (e.g., societal, economic, ethical,
legal) of the application of technology.
Technology assessment is an analysis of
primarily social rather than technical
issues, and is especially concerned with
unintended, indirect, or delayed social
impacts.
It is now becoming more evident
that the assessment of any emerging
or existing technology must, at least,
include consideration of the following
parameters: (1) the potential need for
the procedure, device, instrument, or
drug, (2) the relevant constraints on
the availability of the technology (eg,
absence of donor organs for trans-
plantation, location of treatment fa-
cilities, shortage of trained person-
nel), (3) the cost-effectiveness-cost-
benefits of the technology assessed in
terms of both economic and social
costs, including lives saved, (4) the
legal issues pertaining to the adop-
tion and availability of the technolo-
gy, including risks associated with its
use (eg, where will the technology be
made available?; who is eligible to
receive the technology?; what risks
does the recipient incur in the use of
the technology?), and (5) the ethical
issues concerning the selection of
recipients of the technology, the allo-
cation of resources to health care
programs, and individual patient
rights to health care regardless of
cost and availability. Failure to con-
sider these issues will make it
extraordinarily difficult to anticipate
the long-term implications of any
emerging or existing technology.""1
Cost of Medical Care
In 1980, expenditures for medical
care consumed 9.4% of the gross
national product (GNP)." In this
same year, health care spending
increased by 15.2%, representing a
moderate acceleration over the 12.5%
increase during 1979. This figure is
substantially higher than the 13.4%
growth rate between 1978 and 1979
and is certainly much higher than the
average of 12.2% annually over the
period of 1965 to 1979." Gross
national product increases have aver-
aged 9.2% per year for the same
period. This substantially greater
growth rate in the health care sector
compared with the rest of the econo-
my resulted in the health care share
of the GNP rising from 6.1% in 1965
to the 9.4% level seen today. Between
1950 and 1978 alone, in the United
States, total annual expenditures for
health care and other forms of
health-related activities increased
1,500%." In 1950, medical care ex-
penditures constituted 4.5% of the US
gross GNP.
In analyzing these increased health
expenditures, it is obvious that third-
party payers have, in many respects,
contributed to the rise in health care
costs, primarily because they have
traditionally placed few constraints
on expenditures. In 1979, personal
health care funds supplied by third
parties amounted to $147.0 billion of
the $217.9 billion in personal health
expenditures, or 68% ." Federal, state,
and local governments financed the
largest portion of that amount-
about 40% of the total. Private health
insurance payments covered an addi-
tional 27% of personal health care. In
1980, private insurers, including Blue
Cross and Blue Shield plans, commer-
cial insurance companies, and inde-
pendent plans, paid benefits amount-
ing to $58.1 billion, or 27% of personal
health care expenditures. In 1980,
approximately 76% of the US popula-
tion was covered by private hospital
insurance.
Often the cost of disability is
ignored as a health-related factor.
This is somewhat misleading, since
every chronic disease requires a cer-
tain level of expenditure for medical
care, but, at the same time, the per-
son may be disabled and, consequent-
ly, draws on disability programs for
various cash benefits. The total cost
of illness should reflect not only actu-
al medical treatment costs but the
cost of services and other benefits the
person receives because of his ill-
ness."4'
Table 3 gives a complete breakdown
of government expenditures for ill-
ness-tested welfare programs for fis-
cal year 1975."" As shown here, in
1975, cash payments to disabled per-
sons under these public programs
amounted to more than $23 billion.
The growth of the disability program
is also interesting. As noted by
Stone," disability benefits adminis-
tered through the Social Security pro-
gram, although smaller than retire-
ment benefits in total dollar amount,
are increasing at a much higher rate,
and the number of disability benefi-
ciaries is also growing faster than the
number of retirement beneficiaries
(Table 4). A close examination of the
Supplemental Security Income pro-
gram presents a similar picture-
federal payments to disabled persons
grew by 13.6% between 1977 and 1980,
as compared with an increase of only
8.0% in payments to the aged (Table
5).
The rapidly rising costs of health
care have served to spur interest in
health care technology assess-
ment ."■"■*"° Recently, much blame has
been placed on health care technology
as the "culprit" behind high health
care costs."""'"" Although the total
contribution of new technology to
rising costs is controversial, esti-
mates of the effect of technology on
increased per diem hospital costs
range from 33% to 75%, with 50%
being an average figure." *""' '" De-
tailed case studies have been under-
taken that illustrate the variable
effect of technology on the treatment
of chronic disease." Scitovsky and
McCall,"" for example, looked at the
changing cost of treating 11 different
conditions at the Palo Alto Medical
Clinic in California during a period of
several years. '" They found the real
cost of treating five conditions fell,
while the cost of treating six actually
2050 JAMA, April 15, 1983— Vol 249. No. 15
Health Care Technology — Evans
475
Table 3. — Government Expenditures for Illness -Tested Welfare Programs for
Fiscal Year
1975'
Program
Amount, In Billion Dollars
FadaraJ
State-Local
Total
Disability insurance
(Social Security Administration)
76
7 6
CivtI service disability
1.4
14
Railroad disabilirv
02
02
Black lung benefits
0.6
06
Uniform services
Veterans Administration and military disability
4 7
4 7
Othef (income-tested)
OS
05
Temporary disability insurance
0.9
09
Workman's compensation
13
3.2
45
Public assistance
Supplemental Security Income -disabled
23
23
Aid to families with dependent children
(disabled male head ol household)
06
06
Total
$23-3t
"Data from Stone** and Skolnik and Dales *
tTotal does not include payments made through various private insurance arrangements or payments
made for medical services
Table 4
—Growth of Disability and Retirement Programs Under Old Age.
Disability, and Health Insurance, 1965 Through 1979'
Survivors,
Program
No. ol
Beneflclarlaa,
In Mlltlona
% ol
Incraaaa
Amount of
Bono ma,
In Billion Dollara
%of
Incraaaa
1065 197S
1B6S 187*
Retirement
Disability
139 22 4
1.7 48
61
182
125 593
16 12.6
374
881
'Data from the Department of Commerce. Bureau of the Census "
increased. Closer examination of
these six conditions showed that
there had been a notable increase in
the use of diagnostic tests and thera-
peutic procedures per diagnosis, Lab-
oratory tests per case of perforated
appendicitis rose from 5.3 in 1951, to
14.5 in 1964, to 31.0 in 1971. Inhala-
tion-therapy procedures for myocar-
dial infarction rose from 12.8 per case
in 1964 to 37.5 in 1971.1,J"~
Fineberg and Hiatt" have noted
that, for several reasons, rising medi-
cal costs can be attributed to technol-
ogy. First, although the trend is
toward shorter hospital stays, this is
accompanied by an increased con-
sumption of resources during hospi-
talization. Second, more advanced
equipment design may improve effi-
ciency, but, with increased use of the
equipment and other "induced costs,"
potential savings are never realized.
Third, many new technologies do
more than simply perform old ser-
vices more efficiently— they provide
new and expensive services. The
intensive care unit, for example, is
but a single innovation that in 1974
was found to account for 10% of all
hospital costs."
It is often argued that big, expen-
sive technologies contribute dispro-
portionately to the high cost of medi-
cal care, although the costs and bene-
fits of a new technology largely
depend on how and to which patients
it is applied.**'1"'"' Moloney and Rog-
ers," however, have argued that the
big and highly visible technologies
such as the computed tomographic
scanner "actually account for far less
of the annual growth in medical
expenditures than do the collective
expense of thousands of small tests
and procedures that are more fre-
quently used by physicians and that
individually cost little."
The use of a technology is directly
related to reimbursement for its
use.10" """* Moloney and Rogers*2 sug-
gest that one approach, although
problematic, to slowing the use of a
technology is to develop protocols"
that instruct physicians to use tech-
nologies only when less expensive
methods cannot provide adequate
information on patient care; limit
reimbursement to use according to
these standards." At present, policies
with regard to the reimbursement of
new technologies, if they exist, are
Table 5. — Growth of Expenditures
Under Supplemental Security
Income, 1979 and 1980'
Federal
Payments, In
Billion Dollara
"*of
Incraaaa
Aged
Disabled
25
4.4
2 7
50
80
13 8
'Data from the Department of Commerce, Bureau
ol the Census '"*
Table 6 — Growth in the Medical
Technology Industry*
Sales, billion dollars
No of companies
No. of establishments
1.0
1.366
2.602
1.442
3.203
'Data from Wenchel '"
often inconsistent. Under the Medi-
care program, the major reason for
excluding a technology for reimburse-
ment is when it has not been demon-
strated to be safe and effective.'"""
As described by Bunker and associ-
ates,"1 "the government's reimburse-
ment policy has been left largely to
the commercial and nonprofit carri-
ers to whom the government, by con-
tract, has delegated the responsibility
for processing claims." To accomplish
this objective, some carriers, such as
California and Massachusetts Blue
Shield, have organized their own
technology assessment committees
and procedures. California Blue
Shield has only recently placed limi-
tations on procedures that are consid-
ered experimental. Previously, the
carrier was committed to reimburs-
ing for services that were "reasonable
and necessary."10 At present, there
seems to be no satisfactory uniformly
applied approach to limiting the
growth of technology through alter-
native reimbursement policies.
Controlling the growth and distri-
bution of technology is complicated
by the fact that the medical technolo-
gy industry is large and multination-
al."*"" To slow its growth through
regulation surely would have a multi-
tude of political ramifications. Since
World War II, the medical technology
industry has experienced dramatic
growth in sales, firms, and establish-
ments (Table 6).'" Wenchel1" attrib-
utes much of the growth to the
increased demand for health services
supported by private, voluntary
health insurance and government
programs such as Medicare and Med-
JAMA. April 15, 1983— Vol 249. No 15
Health Care Technology— Evans 2051
476
icaid, Hill-Burton, and Regional Med-
ical Programs. The roentgenography
and electromedical industries have
seen the greatest increase in sales,
showing an increase of $1.8 billion
between 1958 and 1977.'" Consequent-
ly, it is difficult to imagine that the
medical technology industry is willing
to sit idle as new regulations are
introduced to slow the growth of
technology. Perhaps this is most true
in those situations in which existing
rather than emerging technologies
are being scrutinized.
SUMMARY
The foregoing discussion points to
several problems and developments
that indicate the inevitability of
resource allocations to health care
programs. The US population is
aging; chronic disease is becoming
more prevalent, disability a common
occurrence. To meet the needs of an
aging, chronically ill, and disabled
population, a complex array of expen-
sive and sophisticated medical tech-
nologies has emerged. The cost of
these technologies will make it neces-
sary to develop elaborate plans not
only to enable them to be used but to
ensure that people receiving them
derive the maximum expected bene-
fits. Thus, it is apparent that resource
allocation decisions are likely not
only to become a necessity but to
become routine."""
In short, in the future, the demand
for health care will doubtlessly out-
strip available resources."61' The
problem then becomes one of deter-
mining how best to allocate the avail-
able resources to optimize the health
of the population. To accomplish this
objective, it will be necessary to study
carefully new and existing technology
to determine the magnitude of poten-
tial benefits.10""" At the same time,
it will be necessary to increase the
efficiency of the existing health care
delivery system in an attempt to
ensure that maximum benefits are
being derived."* During this process,
it is probable that some types of
medical care can no longer be pro-
vided, or, if provided, they will be
done so on a limited basis, since the
derived benefits are too costly for all
to benefit. The question then becomes
one of determining the best method
of implementing allocation deci-
sions. "*•'" In doing this, it subsequent-
ly will become necessary to ration
care within health care programs
that have been spared from complete
extinction. Although advanced tech-
nology will provide many persons
with a new lease on life, not all are
expected to benefit equally, if at all.
As these allocation and rationing
exercises are undertaken, a new
appreciation of medical ethics will
come about, accompanied by a more
careful assessment of the nature of
death and dying within this socie-
ty.""12 These issues as they apply to
this analysis are more completely
delineated in part II.
This is part I of a two-part article. Part
II will appear in the April 22/29 issue.
Preparation of this article has been made
possible by grant 95-P-97887/0-01 and contract
500-81-0051, provided by the Health Care
Financing Administration.
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JAMA. April 15. 1983 — Vol 249. No 15
Health Care Technology — Evans 2053
Printed and Published in the United States of America
23-029 0-83-31
478
Special Communications
Health Care Technology and the Inevitability
of Resource Allocation and Rationing Decisions
Part II
Roger W. Evans, PhD
ALLOCATION AND RATIONING
OF HEALTH CARE RESOURCES
Of all the resource-shortage crises
this nation is expected to confront in
the future, the problem of resource
distribution is likely to be most acute
and problematic in medicine. :''~1
Persons will be recognized as in need
of, and then denied, benefits that the
medical care provision system is
capable of providing. Instead of an
unidentified mass of persons being
denied access to a needed resource,
persons whose names have become
known to the public will be declared
ineligible for a treatment or service
they are known to require.111 Perhaps
See also pp 2220
and 2223.
this scenario is inhumane, but it is
undoubtedly a true representation of
reality. As already noted, technology
now permits to be saved the lives of
persons who less than a decade ago
would have surely died. Moreover,
technology has made it exceedingly
difficult to specify at precisely what
point life ceases. This has prompted
Crane" to conclude that both medi-
cine and law are moving toward a
"social interpretation" of life.
It should come as no surprise that
the resources available to meet
the demand for health care are lim-
ited. '"'"" Weinstein and Stason,"7 for
example, have pointed out that deci-
From the Health and Population Study Center.
Battelle Human Affairs Research Centers, Seattle
The views expressed in this article are those ol
the author and do not necessarily represent the
views of Ihe Health Care Financing Administration or
the Battelle Human Affairs Research Centers
Reprint requests to Battelle Human Affairs
Research Centers. 4000 NE 4l3t St. PO Box
C 5395, Seattle, WA 98105 (Dr Evans)
sions are already being made— physi-
cians allocate their time, hospitals
ration beds, fiscal intermediaries de-
vise reimbursement policies— all of
which suggest that priorities are
being set. This is not to deny the
recency of problems associated with
resource constraints. Even a few dec-
ades ago, before the proliferation of
medical technology and the perva-
siveness of insurance, constraints on
health care resources were largely
unheard of. In the past, the distribu-
tion of health care resources has been
accomplished by implicitly limiting
their availability or, when available,
restricting people's access to them.'"'
Thus, the concepts of availability and
accessibility are critical to the prob-
lem of resource distribution.'"'" Ra-
tioning is the term often used to
describe the process of differentially
distributing resources. Rationing has
become a value-laden term— one that
implies that persons are likely to be
treated unequally'" Allocation is an-
other term often used to describe the
unequal distribution of resources.
While Webster's New World Dictio-
nary defines rationing as "a fixed
portion; share; allowance," allocation
is to "set apart for a specific purpose,
to distribute according to a plan."
As suggested by the definitions of
rationing and allocation, there is
merit in distinguishing between the
allocation and the rationing of health
care resources. Others have used the
terms macroallocation and micro-
allocation to make a similar distinc-
tion."4 ■'" Regardless of the terms
used, it should be recognized that
allocation and rationing differ with
regard to temporality and level. First,
allocation decisions are likely to pre-
cede rationing decisions. Second, allo-
2208 JAMA, April 22/29. 1983 — Vol 249. No 16
cation is a concept that does not apply
well at the level of the individual
patient but rather is more appro-
priately applied at the aggregate or
health care program level.
In a period when resources avail-
able for health care have become
increasingly constrained, attention is
directed toward making the provision
of health care more efficient. For
example, although much attention
has recently focused on the enormous
cost of the End-Stage Renal Disease
Program, the question being ad-
dressed is not whether patients
should have their Medicare benefits
cut off but rather how treatment can
be provided at less cost. (The total
cost of the kidney program in fiscal
year 1982 is expected to be $1 .8
billion. Stated in other terms, pa-
tients with end-stage renal disease
[ESRD], representing <0.25% of all
Medicare part B beneficiaries, now
account for >9% of total Medicare
part B expenditures. "*) Thus, the
debate over which type of therapy
(primarily home or in-center dialysis)
is least costly is again being hotly
debated.""'7 At the same time, there
is renewed interest in methods by
which donor organ availability can be
increased.1*"'1 Recent hearings once
again have indicated that home dialy-
sis is probably less costly than in-
center dialysis but that kidney trans-
plantation is a greater bargain since
the cost is not only lower in the long
run, but the quality of life of renal
transplant recipients is generally
thought to be better than that of
patients receiving dialysis.'" '" Since
there seems to be room for improving
the provision of ESRD services, there
is only minimal consideration being
given to reduction or discontinuation
Health Care Technology — Evans
Reprinted from the Journal of the American Medical Association
Aprrt 22/29, 1983. Volume 249
Copyright 1983, American Medical Association
479
of benefits that patients with renal
disease currently receive. Thus, re-
sources will continue to be allocated
to the End-Stage Renal Disease Pro-
gram, but, in the future, greater
attention will focus on the intrapro-
gram allocation of resources. It will
be expected that the agency responsi-
ble for administering the program,
the Health Care Financing Adminis-
tration (HCFA), will write regula-
tions that will maximize the use of
those resources made available to the
program; that is, the HCFA will be
expected to promote the least costly
treatment modalities by providing
incentives for their adoption.'"
Should the resources available for
health care become increasingly con-
strained, the Department of Health
and Human Services will be put in a
position wherein interprogram alloca-
tion decisions will become necessary.
These allocation decisions would con-
cern how to distribute resources
across health and, perhaps, social and
other publicly financed programs. For
example, a question might be raised
as to whether the resources currently
used to treat kidney disease might
better be allocated to prevention
activities or to a maternal and child
health care program in which the
derived benefits are likely to surpass
those currently received by patients
with ESRD." In the future, competi-
tion for the available resources is
likely to be great. The high cost of
some new technologies might well
make their widespead use prohibitive.
Should this prove to be the case, it
will then be necessary to consider the
rationing of resources within health
care programs.
Resources are rationed at the indi-
vidual level, while allocation occurs at
the aggregate level. Once it is appar-
ent that all who are in need cannot be
treated, the question then becomes
one of which potential recipients are
going to derive the greatest benefits.
Again, this is precisely what occurred
during the early years of dialysis,
when there was substantial patient
selection by physicians or commit-
tees. At that time, it was decided that
although all patients with ESRD had
a terminal condition, some had better
prospects for treatment than oth-
ers.™IS* The preferred candidates were
selected on the basis of a variety of
criteria, eg, age, medical suitability,
mental acuity, family involvement,
criminal record, economic status (in-
come, net worth), employment record,
availability of transportation, will-
ingness to cooperate in the treatment
regimen, likelihood of vocational re-
habilitation, psychiatric status, mari-
tal status, educational background,
occupation, and future potential.™1"
These criteria served as the basis on
which scarce resources were rationed.
Similar criteria currently are used to
select potential heart transplant re-
cipients and, thus, also serve as a
rationing mechanism.'""" The deci-
sion to extend Medicare benefits to
patients with ESRD resolved the
rationing problem for the federal gov-
ernment. However, as noted by my-
self and associates, '" the federal gov-
ernment "appears to have been more
concerned with ridding itself of the
moral dilemma of indirectly deciding
who could live and who would die in a
country of almost unlimited re-
sources" than with simply trying to
deal with the more general problem
of costly medical care.
Now that the federal government is
at least willing to entertain the possi-
bility of differentially allocating re-
sources to health care programs, it
inevitably will also have to entertain
the need to ration health care
resources once interprogram alloca-
tion has occurred and the efficient
use of available resources is maxi-
mized. Should resources be con-
strained further and no greater effi-
ciency attained, it would become nec-
essary to ration the available re-
sources to certain persons based on
some uniform set of guidelines.
The foregoing raises two important
questions that have yet to be
addressed— (1) On what basis will
resource allocation decisions be
made? (2) How are criteria for ration-
ing likely to be developed?
ESTABLISHING CRITERIA
FOR EXPLICIT
RESOURCE ALLOCATION
In the medical literature, one
increasingly finds medical proce-
dures, practices, and technology sub-
jected to what is commonly referred
to as "cost-effectiveness and cost-
benefit analysis."5"^"0,1"'*' Although
the two are related, they are different
approaches to the assessment of
health practices and technology. Nev-
ertheless, both cost-effectiveness
analysis (CEA) and cost-benefit anal-
JAMA. April 22/29, 1983— Vol 249. No 16
ysis (CBA) are presented as tools that
can be used by the policymaker to
make resource allocation decisions.
A CBA or a benefit-cost analysts
requires that both costs and benefits
be assigned monetary values.'*" Vari-
ous methods have been proposed to
measure the resource value of health
care benefits. These include, for
example, expected productivity loss
based on discounted future earnings
at the age of death or disability." ''"
. The benefit-cost framework thus con-
verts decreased deaths and disability
into increases in productivity and
treats them as the indirect benefits of
a health intervention. Thus, indirect
benefits are then combined with any
direct savings in health resource con-
sumption (the direct benefits) to yield
a net value.
A CEA, unlike a CBA, does not
require that both costs and benefits
be assessed in monetary terms.
Instead, the aim of a CEA is to
measure benefits in nonmonetary
terms using mortality, morbidity, or
quality-adjusted life years. To this
extent, a CEA preserves a sense of
intangible health care benefits,
whereas a CBA typically notes these
but fails to assess them.'*' A CEA is
particularly useful for comparing
alternative approaches with the
treatment of a given medical condi-
tion. For example, in-center hemodi-
alysis, home hemodialysis, continuous
ambulatory peritoneal dialysis, and
kidney transplantation all represent
alternative approaches to the treat-
ment of ESRD. A CEA allows one to
compare these treatments to deter-
mine which provides the greatest
benefits at the least cost."" Similarly,
heart transplantation might be com-
pared with its alternative— tradi-
tional medical and surgical man-
agement—as approaches to the
treatment of end-stage cardiac dis-
ease (ESCD)." Finally, percutaneous
transluminal coronary angioplasty
might be compared with coronary
artery bypass surgery as alternative
approaches to the treatment of ather-
osclerosis.""" In all these instances,
the goal of a CEA is the same— to
determine which treatment approach
to a given condition yields the great-
est benefits at the least cost.
Both CEA and CBA can be applied
on a larger scale than described here-
in. This application is critical to both
intraprogram and interprogram allo-
Heallh Care Technology — Evans 2209
Printed and Published in the United States ot America
480
caticin decisions. A CEA can be used
to compare the benefits derived from
various health care programs to
determine which program (not specif-
ic treatment approach) yields the
greatest benefit at the least cost,
provided the benefits of each program
being compared are expressed in the
same terms (M. C. Weinstein, PhD,
written communication, April 14,
1982). For example, kidney dialysis
can be compared with heart trans-
plantation to i 2e which has the great-
est ben..;it3, with benefits expressed
in terms of mortality, morbidity, or
quality-adjusted life years. Weinstein
describes this process as follows:
The comparison of cost-effectiveness ra-
tios serves as a basis for allocating
resources if the objective is to maximize
health benefits. Thus, if kidney dialysis
has a cost-effectiveness ratio (relative to
the next best alternative for ESRD) of
$60,000 per quality-adjusted life year, and
cardiac transplant has a cost-effectiveness
ratio (relative to the next best alternative)
for ESCD) of $50,000 per quality-adjusted
life year, then resources should be allo-
cated to the latter ahead of the former.
In this case, the proposed interpro-
gram analysis strictly applies to
health care programs. Another perti-
nent example might be to compare
the cost of a potential maternal and
child health program with the End-
Stage Renal Disease Program or a
potential ESCD program.
If the goal of the interprogram
analysis is to compare the expendi-
ture of health care resources with
other socially desirable uses of re-
sources, such as a public assistance
program, a cost-benefit analysis is
appropriate. Within the CBA frame-
work, all expenditures and benefits
are converted to monetary terms,
which permits direct comparisons to
be made among various diverse pro-
grams. The results of such an analysis
may indicate that resources should be
reallocated from social and other
publicly financed programs to sup-
port health programs and vice versa.
The problem with the CBA frame-
work, however, is the requirement
that human lives and quality of life
be valued in dollars.""
Ultimately, the major objective of
an interprogram analysis that in-
volves only health programs or health
and other publicly financed programs
is to ensure that those programs that
produce the greatest benefit will be
Table 7 —Applying Cost-effectiveness and Cost-Benetit Analysis to Program
Allocation Decisions
Type of Decision Required
Cost-effectiveness
Analysis (CEA)
Cost-Benefit
Analysis (CBA)
Method
of Choice
Intraprogram allocation decision
Yes
Yes
CEA
Interprogram health allocation
decision
Yes
Yes
CEA
Interprogram health v other
publicly financed program
allocation decision
No
Yes
CBA
those that receive the greatest sup-
port from the federal government. In
this regard, it is apparent that, given
limited resources and a need to allo-
cate them in the most effective man-
ner possible, a CEA or a CBA allows
programs to be ranked according to
their effectiveness or benefits derived
or both. Weinstein and Stason"' have
summarized how this is done in the
case of CEA as follows:
Alternative programs or services are then
ranked from the lowest value of the cost-
effectiveness ratio to the highest, and
selected from the top until available
resources are exhausted. The point on the
priority list at which the available
resources are exhausted, or at which socie-
ty is no longer willing to pay the price for
the benefits achieved, becomes society's
cut-off level of permissible cost per unit
effectiveness. Application of this proce-
dure ensures that the maximum health
benefit is realized, subject to whatever
resource constraint is in effect.
Thus, it is now possible to see that the
allocation of health care resources
and resources available to other pro-
grams as well can be subjected to a
formalized set of procedures. By
requiring that all assumptions are
cleary stated, it is possible to perform
the necessary quantitative analyses
required to make the appropriate
allocation decisions. In those areas
where the data are least secure, it is
possible to undertake sensitivity
analyses to explore further the im-
pact of decisions under differing
assumptions.
Table 7 summarizes which type of
analysis can be applied to various
allocation decisions. If possible to
achieve, a CEA should be the method
of choice. In only one instance is it
likely that a CEA would be inappro-
priate. This is in the case wherein an
interprogram analysis is required to
compare health program expendi-
tures and benefits with non-health-
related program expenditures and
benefits. In this case, it would be
necessary to express in monetary
terms the benefits derived from the
program. If an intraprogram alloca-
tion decision is required, a CEA
should always be the method of
choice, while, in principle, both a CBA
and CEA could be applied to making
an interprogram health allocation
decision.
ESTABLISHING CRITERIA
FOR EXPLICIT RATIONING
The resource rationing problem is
different from the resource allocation
prohlem. Although, in many respects,
allocation decisions set the parame-
ters and constraints within which
rationing occurs, it is somewhat more
difficult to submit the rationing pro-
cess to a formalized set of procedures.
The literature on clinical decision
making, although not solely intended
to be a framework for rationing, does
provide an excellent framework with
which to view rationing.
Once resources have been allocated
to programs, and should these not be
sufficient to meet the demand of all
in need, clinicians are left with the
problem of deciding which patients to
treat.'""* The problems that were
faced in the early days of kidney
dialysis already have been described,
pointing to obvious problems with
any system that basically discrimi-
nates among people in the distribu-
tion of health care resources."11
According to many, all people have a
"right to health care" and, in a coun-
try as wealthy as the United States,
no one should go untreated.""" Yet,
people often fail to recognize that
with every right there also is an
obligation.'1*"" People have a respon-
sibility, an obligation as it were, to
care for themselves in a manner that
will maximally ensure good health
(eg, eat a good diet and exercise
daily). Unfortunately, a vast majority
of the population fails to fulfill its
end of the "social contract" and
chooses to engage in practices and
2210 JAMA. April 22/29, 1983— Vol 249. No. 16
Health Care Technology — Evans
481
behavior that are known to be detri-
mental to their health (eg, excessive
smoking, drinking, eating, and failure
to exercise). Therefore, it could be
argued that if everyone has a right to
health care, then appropriate con-
tracts should be drawn up to ensure
that everyone keeps their end of the
bargain.1" This, of course, would
require regulatory reform and strict
enforcement, something that would
be difficult and costly to undertake.
Ultimately, however, the limits of the
broad humanistic concept of a right
to health care must be recognized.
Within the context of rationing, those
persons who have done the most to
preserve their health could conceiv-
ably be the first to benefit from the
available resources."'"
The problem grows in complexity
when it is recognized that the final
decision concerning the rationing of
resources will be the shared responsi-
bility of the clinician or medical team,
the patient, and any other represent-
ative of the patient (eg, family or
nearest of kin).'" It is unlikely that
explicit exclusion criteria will be
developed that are equally palatable
to all involved.190"' Thus, any criteria
for rationing would be interpreted
and practiced by individual clini-
cians.'"'" This is consistent with the
concept of the "clinical mentality"
advanced by Freidson,'" which sug-
gests that clinicians see each patient
as a special case and treat each
accordingly. Medical practice is typi-
cally occupied with the problems of
individuals rather than of aggregates
or statistical units. To impose a set of
rationing criteria that must be
strictly adhered to implies that
patients need not be considered as
unique individuals but rather as
aggregates. This would, in fact, repre-
sent a radical restructuring of the
process of rendering clinical judg-
ment.19*
In the final analysis, it is possible
to establish some general guidelines
on, perhaps, a condition-by-condition
basis, to be applied to decide whether
a patient should be treated.'" The
problem, however, is that all cases
will have to be reviewed individually,
with explicit attention given to the
manner in which each patient de-
viates from the guidelines. These
decisions are likely to be made when
any of the following conditions are
met: (1) the treatment is determined
to be futile, (2) the patient declines
treatment, (31 the quality of the
patient's life is unacceptable, or (4)
the cost of providing care is too
great.'""' In evaluating each case,
what people decide to do will be
subject to considerable variability.
What is presented as a formal policy
may be informally practiced in a
variety of ways. Policy and practice
can differ remarkably.
As described here, rationing is the
process by which criteria are applied
to selectively discriminate among pa-
tients who are eligible for resources
that have been previously allocated to
various programs. Rationing criteria,
although conceivably developed at the
aggregate level, are likely to be inter-
preted and implemented at the indi-
vidual level. Thus, there are two
major problems associated with ra-
tioning. These are (1) the develop-
ment of acceptable criteria for with-
holding treatment on a condition-
by-condition basis and (2) identifying
that person or those persons who
should make the decision not to
treat.
Childress," in his discussion of
rationing, has distinguished between
what he refers to as "rules of exclu-
sion" and "rules of final selection."
The first set of rules establishes the
pool from which the final selections
are made. The final selections are
then based on the rules of final
selection. Childress'" provides the fol-
lowing advice: "The best approach to
determining the pool for final selec-
tion is to forget that the resource is
limited and to exclude only those
patients whose medical and psycho-
logical condition would certainly pre-
vent successful treatment." The rules
for final selection, however, are more
controversial. Major alternatives in-
clude social worth criteria or some
form of chance (eg, randomization,
lottery, or "first come, first treated").
Rescher,'" pursuing this same line of
thought, has suggested that there are
two biomedical and three social fac-
tors relevant to final selection. Rela-
tive likelihood of successful treatment
and life expectancy are the relevant
biomedical factors, while the social
factors include family role, potential
future contributions, and past ser-
vices. All of these criteria are diffi-
cult to quantify and evaluate.
At this point, it is again important
to reiterate that the most critical
decisions that must be confronted
today are those involving the alloca-
tion of resources across health care
programs.'" Once these decisions
have been made, it will then become
important to consider whether ra-
tioning will be necessary and what
form it will take. It is precisely at this
point that the nature and require-
ments of clinical decision making will
become increasingly subjected to pub-
lic and professional scrutiny."*™ Fur-
thermore, it is at this point that
patients and their next of kin will
become increasingly involved in the
decision-making process, and quanti-
ty and quality of life trade-offs will
become important.'"" ' The deci-
sion-making process is well described
in the literature." "'•'■ ""•'""'
RESOURCE ALLOCATION
IN PERSPECTIVE
Most discussions of resource alloca-
tion and rationing are narrowly
focused and lack perspective. Atten-
tion is often directed to how health
care resources are spent and not how
a reallocation of resources from other
government programs, such as de-
fense and other publicly financed pro-
grams, might produce considerable
gains in the health status of the
population. Take, for example, the
controversy that currently surrounds
the End-Stage Renal Disease Pro-
gram. This program is obviously cost-
ly, and the benefits derived by many
patients have been reported to be
few.""" Policymakers now question
whether this program will be allowed
to continue in its current form.™'"
Unfortunately, excessive attention
has probably focused on the kidney
program. The problems associated
with providing medical care to pa-
tients with ESRD is only symptomat-
ic of a more widespread problem—
health care costs continue to escalate
as a larger number of people increas-
ingly benefit from new and expensive
health care technology. However, it
must be recognized that other health
and social programs are equally cost-
ly. For example, in 1981, an estimated
100,000 to 125,000 Americans under-
went coronary artery bypass surgery,
first performed in 1968, and the num-
bers continue to rise.'" Yet those who
have the surgery amount to only
0.04% of the nation's population. At
$2.0 billion per year (a conservative
estimate according to Randal), coro-
JAMA. April 22/29. 1983— Vol 249, No. 16
Health Care Technology — Evans 2211
482
Table 8 —Budget Authority by Function
Function (Budget Code)
Actual, In
Billion Dollar
1981
Estimates, In Billion Dollar*
1982 1983 1984 198S 1986
1987
National defense (050)
182-4
2189 2630 2910 338.0 374 9
4084
Health (550)
889
79.2 778 814 93.6 116.7
128.3
Administration of justice (750)
4.3
4.3 4.5 4.6 45 4.6
46
Table 9 —Budget Outlays by Function
Function (Budget Code)
Actual, In
Billion Dollar
1981
Estimates, In Billion Dollars
1982 1983 1984 1985 1986
1987
National defense (050)
159 8
187 5 221 1 253.0 292.1 331 7
3642
111.9
Health (550)
660
73 4 78 1 84.9 93.5 102 4
Adminisfration of justice (750)
47
4.5 4.6 4.6 4 5 4 5
4 6
Table 10. — Conduct of Research and Development in Defense and Health*
Department or Agency
Obligations, In Outlays. In
Billion Dollars Billion Oollari
1981
1982 1983 1981 1982
1983
Defense and military functions
Health and human services
16.5
206 245 157 188
22.7
4.0
4.0 4.1 4.0 3.9
4.0
'Data from Inglehart '
nary artery bypass surgery accounts
for about 1.0% of the total annual US
health bill.""" The growth in the
number of coronary artery bypass
procedures performed each year has
been substantial. In 1973, it was esti-
mated that 38,000 such procedures
were carried out in the United States
at a cost in excess of $400 million."
Collectively, coronary artery bypass
surgery is the most costly operation
performed in this country and has
boosted private health insurance pre-
miums for the population as a
whole.2"
Interestingly, for most patients, the
efficacy of coronary artery bypass
surgery is questionable."2" "' There is
evidence that the procedure is effec-
tive in prolonging the life of patients
who suffer from a major blockage of
the main trunk of the left coronary
artery, but evidence of the efficacy of
the procedure on patients with
"three-vessel disease" or in whom all
three arteries are blocked is less
clear. These patients presumably
make up 30% to 40% of the total.
Moreover, the rate of return to work
among patients who have coronary
artery bypass surgery is not impres-
sive.2"2*"'
The costs associated with neonatal
intensive care are also high and are
comparable with the costs of ESRD
and coronary artery bypass surgery.
A recent case study on the costs and
effectiveness of neonatal intensive
care estimates that the average
expenditures per patient in 1978 were
about $8,000, with costs for some
patients well over $40,000."" Since
there are no national data on the
volume of neonatal intensive care
being provided in the United States,
only rough estimates can be produced,
based on studies with small sample
sizes and varying definitions of levels
of care. Burdetti and associates pro-
vide the following estimates of neona-
tal intensive care supply and use:
1. Neonatal intensive care unit ad-
missions—6% of all live births go to
intensive care, accounting for 200,000
admissions each year.
2. Estimated average length of
stay— eight to 18 days per patient.
3. Number of hospitals with neona-
tal intensive care units— 600.
4. Number of intensive care beds—
7,500.
5. Total cost of neonatal intensive
care— $1.5 billion each year.
Thus, based on the foregoing, ques-
tions being asked about the treatment
of patients with ESRD could also be
asked of coronary artery bypass sur-
gery and neonatal intensive care.
Since Medicare finances only a small
percentage of these procedures and
2212 JAMA, April 22/29. 1983— Vol 249. No 16
services (perhaps 20.0% nationwide
in the case of coronary artery bypass
surgery, with Medicaid paying for
another 5.0% ), the amount of publici-
ty they have attracted remains small.
In the case of coronary artery bypass
procedures, the majority of patients
rely on third-party payers, but, even
so, their out-of-pocket expenses may
equal 20% of the total bill."1
To provide even greater perspective
for this discussion, the current level
of defense spending as well as
expenditures associated with the fed-
eral corrections system should be
examined. It is well recognized that
the resources devoted to national
defense dwarf those available to
health and social programs.2" It is
less well recognized, however, that it
now costs as much per year to support
a convicted felon in the federal cor-
rectional system as it does to keep a
person alive on home hemodialysis. It
seems a paradox that producing and
maintaining the means to destroy life
and warehousing in correctional facil-
ities people who have outright taken
the lives of others continues to absorb
enormous resources that might justi-
fiably be used otherwise. Why is it
that when health care programs are
criticized as being too costly, no
attempt is made to put this in per-
spective by looking at other, less
desirable uses of resources?
Table 8 gives budget authority and
Table 9 budget outlays as provided in
the fiscal year 1983 budget of the US
government.2™ National defense ex-
penditures are more than twice those
available for government-financed
health care programs. The size of the
budget for the administration of jus-
tice is minuscule when compared with
either the budgets for national de-
fense or health; yet, when one exam-
ines that portion of the justice budget
devoted to corrections, it is not incon-
sequential, considering how the re-
sources are used. In 1978, the average
daily population in federal correc-
tional facilities peaked at 29,347.
Today, the average daily population
has dropped to approximately 27,000.
The cost per person per year (fiscal
year 1981) for supporting persons
convicted of violating federal laws as
well as persons charged with crimes
and detained for trial or sentencing is
approximately $13,000 ($352 million
per year for 27,000 persons). Yet, as
the prison population is declining,
Health Care Technology— Evans
483
inflation is driving up the costs of
operations to a point where outlays
for operating correctional facilities
are expected to be about $367 million
in 1982 and $386 million in 1983.
Iglehart has recently summarized
the proposed budget (fiscal year 1983)
for major federal departments and
agencies. Figures for defense and mil-
itary functions and those for health
and human services are given in
Table 10. In reviewing the total budg-
et, Iglehart concluded that, insofar as
research and development funds are
concerned, "research in physics, engi-
neering, and other fields with poten-
tial military and industrial applica-
tions fared considerably better than
did medical research."
For fiscal year 1984, the Reagan
administration has requested a Na-
tional Institutes of Health (NIH)
budget of $4.1 billion, representing an
increase of $73 million, or 1.8% over
last year's proposal. Once the pro-
jected 4.9% inflation rate for 1983 is
considered, however, the NIH will end
up losing this modest gain in terms of
real dollars.
Not surprisingly, the Department
of Defense (DOD) is expected to fare
well in 1984. Since his election, Presi-
dent Reagan has increased annual
outlays for the DOD by 33%, with
plans to increase the DOD budget by
another 14% in 1984. As of this date,
the administration has requested
$274 billion for the DOD, with some
congressmen indicating that this fig-
ure will be reduced by at least $15
billion. Overall, despite pending cuts
in the DOD budget, it is still expected
to increase by 30.0% , reaching a total
of $29 billion, or 65% of the total US
budget for research and develop-
ment.
In the final analysis, it is apparent
that resources directed to health care
programs and health-related activi-
ties are not excessive when compared
with other publicly financed pro-
grams of somewhat dubious value.''
At the same time, it is evident that
some health care programs have been
unjustly criticized when it is recog-
nized that other medical procedures
are equally as costly as those current-
ly receiving careful scrutiny, such as
the End-Stage Renal Disease Pro-
gram. Thus, the following conclusion
is unequivocal— resource allocation
decisions must be viewed in perspec-
tive.
FACING THE INEVITABLE
— DEATH AND DYING
As described previously, numerous
ethical issues surround the allocation
and rationing of health care re-
sources. When not all will benefit, the
dilemma becomes one of choosing
who will. The ethical problems inher-
ent in CBA and CEA are by no means
resolved.""" It is apparent, however,
that should these procedures be
applied to resource allocation deci-
sions, this society will become acutely
aware of mortality.'" "'
Historically, within this society,
there is a preoccupation with health,
almost to the point where death is
observed as the ultimate of all evil.
Major social surveys of the popula-
tion have continuously shown that
health is highly valued.'" Interest-
ingly, however, it has become increas-
ingly difficult to define the pa-
rameters of health. Even a person's
need and ability to interact with oth-
ers has been designated as "social
health." """ Perhaps this is because
of the fact that the most commonly
accepted definition of health is that
provided in the Constitution of the
World Health Organization,"'"' which
states that "health is a state of
complete physical, mental and social
well-being and not merely the ab-
sence of disease or infirmity." Conse-
quently, at least three types of health
are found in the literature— physical
health, mental health, and social
health. It is now difficult to deter-
mine what is and what is not health.
Preoccupation with health is obvi-
ously an unacknowledged preoccupa-
tion with death and, perhaps, the
process of dying. While many people
fear death, the overriding concern is
with dying, ie, the process by which
death comes about. For the most part,
this society seems to be fully com-
mitted to the preservation of life at
all costs, despite the quality of life the
afflicted is likely to lead. It has only
been in recent years that clinicians
and the public have been willing to
straightforwardly acknowledge and
verbalize their concern with what
might be called the "quantity v quali-
ty of life trade-off."* Accompanying
this, of course, have been open dis-
cussions of the value of human
life.'*" "" The uncertainty of what
•References 21, 22. 128. 156, 164, 173, 201-203,
210, 243
follows death has led many to eschew
death in favor of living, regardless of
the quality of their existence. Recent
studies, however, show that persons,
when faced with the prospect of a
long-term chronic illness, are at least
willing to consider the prospects of a
shorter but higher quality of life."* "
This in itself suggests that people
have come to grips with the notion of
death. Nevertheless, widely held reli-
gious beliefs and convictions would
suggest that a large proportion of the
population is unwilling to entertain
the possibility of voluntary euthana-
sia or passive suicide as solutions to
prolonged suffering."'" Some religious
groups would, in fact, consider life
with catastrophic long-term illness
an act of God and the illness a test of
their religious conviction. In fact,
they may believe that illness en-
hances their ability to demonstrate
their religious faith to others in a
testimonial fashion.
Over the years, technology- has
evolved to a point where the de-
termination of death is increasingly
problematic/'"' "" In fact, the new
understanding of death is largely a
consequence of technological ad-
vances in life-support systems. The
President's Commission has now
grappled with the problem of trans-
lating the current physiological un-
derstanding of death into acceptable
statutory language. The Commission
was also interested "in the dispute
between 'whole brain' and 'higher
brain' formulations of death and
appraising currently used brain-
based tests for death, which have
become increasingly varied and so-
phisticated."" A set of guidelines has
been established for the determina-
tion of death, but these are not
accepted by all.2'"'
Thus, the ability of technology to
stave off premature death through a
variety of means makes it increasing-
ly likely that this society will be
unable to fully come to grips with
death in a manner that facilitates the
withholding of treatment when the
expected outcomes are negligible or
counterindicative to the well-being of
the patient and his or her next of kin.
Surprisingly, however, there is con-
siderable interest in hospice care in
the United States, which, in effect,
suggests that a decision to discon-
tinue vigorous treatment is accept -
able/*'"*4 As described by Saunders, r
JAMA, April 22/29, 1983 — Vol 249. No 16
Health Care Technology — Evans 2213
484
"The hospice movement sets out to
ensure that every person who can no
longer benefit from the increasing
complexity of the general hospital
will have the support he and his
family need. The whole family is the
unit of care and should also be seen as
part of the caring team." By most
standards, the hospice concept is not
a new innovation; it dates back to as
early as 1893, when St Luke's Hospi-
tal was established in London.
Perhaps unfortunately, it is rarely
the case that the similarity between
hospice care and the voluntary with-
holding of treatment is recognized. ,1'
The parallel is close, yet it is current-
ly argued that patients, under all
circumstances, should receive every
extraordinary means of care available
to prolong life. Only when society is
fully able to come to grips with death
and dying is it likely that "policies
and procedures for decisions not to
treat" not only will be formulated but
will also be followed. This period is
likely to be hastened as financial
constraints force the issue. Putting
this in prespective. Manning""1 has
stated:
Somewhere along the way, consciously or
unconsciously, explicitly or implicitly, so-
i n-t> will have to make some basic deci-
sions about the allocation of economic
resources as between human beings of
advanced years and those who are young-
er We have not begun to consider the
violent social dislocation that would be
brought about if a large fraction of the
population were to be kept alive for signif-
icantly longer periods of time,
As noted previously, the problems
that must be addressed are essential-
ly ethical or, perhaps, ethical-legal. IM
New medical technology has not only
dramatically changed the practice of
medicine, but it has also raised a
variety of issues with which clinicians
are rather uncomfortable. The prob-
lem, however, is that these issues are
relatively new and must be worked
through carefully. Many of the issues
surrounding the allocation and ra-
tioning of resources are almost meta-
physical in nature. There is no clear-
cut solution to the problems they
instill for society. Ethics are relative
to time, place, and, perhaps most
importantly, culture The anthropolo-
gist Ruth Benedict, ''■, in describing
the "cultural relativist" perspective
on culture, made a profound observa-
tion. She stated:
No man ever looks at the world with
pristine eyes He sees it edited by a
definite sel <>f customs and institutions
ami ways of thinking. Even in his philo-
sophical probings he cannot go behind
these stereotypes; his very concepts of the
trui' anil the false will still have reference
t<> his [(articular traditional customs.
The cultural relativist perspective
nicely summarizes the problems in-
herent in making resource allocation
and rationing decisions. Even though
based on explicit and hopefully ratio-
nal criteria, any plan that is eventual-
ly adopted is certainly debatable from
the perspectives of others. To adopt a
set of criteria is to make a decision
about limiting treatment. On the oth-
er hand, to treat all patients with a
given disorder or within a given dis-
ease category, regardless of derived
benefits, necessarily implies the with-
holding of treatment from patients
with other disorders. The question is
truly one of priorities. Data can be
used to set priorities, but human
judgment must be exercised to deter-
mine which priorities will hold.
The future is likely to be interest-
ing. The conscious development of
explicit allocation criteria, as a first
step in the direction of wisely using
limited resources, will be controver-
sial. Questions must be raised as to
how resources will be allocated not
only to health programs but social
programs as well. There are certainly
many patients with diseases and eso-
teric medical conditions who could
benefit from additional resource allo-
cations. In 1972, it was decided that
patients with ESRD would be eligible
for Medicare benefits, yet there were
and are many other patients with
diseases and conditions who could
have sustained the prolonged atten-
tion of government agencies.
Allocation issues will obviously be
submitted to a complex sociopolitical
decision-making process. Decisions
can be made on the basis of allocation
tools such as CEA or CBA, or a grim
political battle could be waged be-
tween different lobbying groups, each
representing the special interests of
patients with specific diseases or con-
ditions. In either case, the first deci-
sion will be as to which patient
groups will receive support lie. the
resource allocation decision); then, as
resources continue to dwindle, alloca-
tions will be made within programs
and decisions will be made as to how
2214 JAMA. April 22/29. 1983 — Vol 249. No 16
clinicians might ration the limited
resources made available to them
Increasingly, it is apparent that this
scenario approximates the situation
of the kidney disease program today.
As already noted, people at all levels
of government are concerned about
the amount spent on the kidney pro-
gram and are looking for ways to
stretch what seems to be increasingly
finite resources. In this regard, it
could be stated that the "battle" has
just begun and that the "war" is yet
to be fought.
While the dilemmas created by
resource allocation and rationing de-
cisions are undeniable, it would seem
that they have and will continue to
provide an impetus for a reconsidera-
tion of the meaning of death and the
essence of life. Reasonably acceptable
criteria have been established for the
determination of death, yet the very
essence of life continues to be elusive.
People do seem to be on the verge of
seriously valuing thier lives, not only
in terms of longevity but in terms of
quality."'11
Although Condorset envisioned
that a "period must one day arrive
when death will be nothing more than
the effect either of extraordinary
accidents, or the slow gradual decay
of vital powers; and that the duration
of the interval between the birth of
man and his decay will have no
assignable limit," Choron:51 has aptly
pointed out that "the postponement
of death is not a solution to the
problem of the fear of death. .
There still will remain the fear of
dying prematurely."
In his treatise on death, Ernst
Becker" shows that the fear of death
is universal and that this fear
"haunts the human animal like noth-
ing else; it is a mainspring of human
activity— activity designed largely to
avoid the fatality of death, to over-
come it by denying in some way that
it is the final destiny of man." He
argues that far too much effort is put
into establishing immortality, in his
words, into establishing a "formula
for triumphing over life's limita-
tions." People have failed to take life
and its limitations seriously. He con-
cludes his discourse, as follows, with a
challenge for those who have used
science to define the very essence of
life:-4
The problem with all the scientific manip-
ulators is that somehow they don't take
Health Care Technology— Evans
485
life seriously enough; in this sense, all
science is "bourgeois," an affair of bureau-
crats. I think that taking life seriously
means something such as this: that what-
ever man does on this planet has to be
done in the lived truth of the terror of
creation, of the grotesque, of the rumble of
panic underneath everything- Otherwise it
is false. Whatever is achieved must be
achieved from within the subjective ener-
gies of creatures, without deadening, with
the full exercise of passion, of vision, of
pain, of fear, and of sorrow. How do we
know that our part of the meaning of the
universe might not be a rhythm in sor-
row?
Had Becker devoted his attention to
an analysis of the full implications of
life-prolonging, advanced biomedical
technology, it is difficult to speculate
what he would have concluded. It is
likely, however, that he would have
concluded that western society has
become too infatuated with the fear
of death and has failed to realize the
true essence and value of life, despite
its length.
Comment
I have attempted to put modern
technology into perspective by noting
that technological innovation is in
response to the demand created by
the increased life expectancy and
changing age distribution of the pop-
ulation and the increased prevalence
of chronic disease and its concomitant
disability. Increasingly, it is recog-
nized that sophisticated medical tech-
nology, however, is not without its
price. In recent years, it has been
argued that technology has been a
major contributor to rising health
care costs in this country. Whether
technology will continue to be viewed
as the culprit behind rising health
care costs is yet to be seen.
Efforts are now being made to
control technology by a more thor-
ough, comprehensive, and ongoing
assessment of new, emerging, and
existing technological innova-
tions/"" '* In this regard, Relman™"
has correctly argued that one effec-
tive method of moderating the cost of
medical care, while improving its
quality, is to initiate "a major new
national program of support for the
evaluation of medical procedures of
all kinds." From his perspective, it is
the cost of ignorance associated with
medical technology that is too great,
not medical progress. In Relman's
words, "The cost culprit is not tech-
nology per se, but only technology
that is ineffective, superfluous, or
unsafe.""' * In short, the goal of
technological assessment should not
be to curb the development of tech-
nologies but rather to provide the
means for an unbiased evaluation of
new technology before it becomes too
widely diffused in practice. To meet
this goal, Bunker and associates'""
have proposed the establishment of a
private, nonprofit corporation for the
collection, analysis, and dissemina-
tion of data on medical procedures
and for the support of new clinical
trials. The Institute for Health Care
Evaluation, as they refer to it, would
be intended to fill partially the void
created by the abolition of the ill-
fated National Center for Health
Care Technology."' This Institute
would have neither policy-making nor
regulatory functions. At the present
time, the HCFA has taken on an
increasingly visible role in the assess-
ment and regulation of new health
care technology.'''" This role is evi-
denced by two generic types of policy
decisions that the HCFA must make,
namely, (1) coverage decisions—
whether an item or service is one for
which the program can pay— and (2)
reimbursement decisions— how much
is appropriate to pay for a covered
item or service.
Despite Bunker's proposal for an
Institute for Health Care Evaluation
and the remarkable and noteworthy
efforts of the Office of Technology
Assessment, the foregoing discussion'
concludes that technological assess-
ment, although likely to increase the
efficiency of the health care provision
system, will not be sufficient to whol-
ly resolve impending budget con-
straints proposed by the Reagan
administration. There are, indeed,
limitations on the resources that can
be allocated to health care programs,
although some reallocation decisions
would serve to stave off the inevita-
ble. In preparation for the inevitable,
plans must be made and techniques
developed for the effective allocation
and rationing of health care re-
sources. Various suggestions have
been offered as to how cost-effective-
ness and cost-benefit analytic tech-
niques can be applied to the making
of intraprogram and interprogram
allocation decisions. Clinical decision
analysis, although imperfect, is of-
fered as a possible approach to deal-
ing with the resource rationing dilem-
ma.
The increasingly apparent need to
allocate and ration health care re-
sources has led to a careful scrutiny
of medical care costs. Health econo-
mists continue to point out that
health care costs are almost out of
control and that a major solution to
this problem is to make the current
service provision system more effi-
cient through various competitive
strategies, despite the fact that recent
reports indicate that competition can
have a negative impact on the quality
of care patients receive."' Taking a
differing viewpoint, other commenta-
tors have correctly pointed out that
the health care industry, employing
approximately 4.3 million workers, is
the second largest industry in the
United States and that reductions in
health care through competition or
other strategies would serve to dis-
place a large number of persons in
this industry.'*0 The effect would be
dramatic as displaced health care
workers "would either displace others
from their jobs or go on the welfare
rolls. Either way one looks at it, a
shrinkage of the health-care industry
would create a ripple effect through-
out our economy."110 This has led
Kolff to suggest that efforts to con-
trol health care costs through careful
technology assessment "totally ne-
glects the notion that we should move
towards a service oriented economy
instead of towards an industrial pro-
duction directed economy" (W. J.
Kolff, MD, PhD, written communica-
tion, Feb 22, 1983). He asks, "What
are we to do with our unemployed?
Unless we expand our 'services,' there
is no solution."
The causes and cure of medical cost
inflation are only partially under-
stood and, thus, remain debatable.
Jellinek and others,'"'" however, be-
lieve that there are factors other than
the "delivery of health care or the
marketing of illness" that have led to
increased spending in the health care
sector. Jellinek'" believes that the
continued rise in health care expendi-
tures is a result of increased aliena-
tion and depersonalization associated
with post- World War II society. The
response of society is to compensate
by aggressive attention to the individ-
ual when he or she becomes ill. Jelli-
nek"" summarizes his position as fol-
lows:
JAMA, April 22/29. 1983— Vol 249. No 16
Health Care Technology — Evans 2215
486
Societal willingness to support extraordi-
narily expensive new medical technology
and advanced training, which implicitly
communicates a willingness to place a
high value on individual human life in
contrast to the low value implied by
industrial depersonalization, may repre-
sent one important form of adjustment of
the social contract. The increase in socie-
ty's expenditures for medical care may
constitute a stabilizing force necessary to
counter the destabilizing impulses gener-
ated by continued economic development.
In the final analysis, however, per-
haps Jellinek's"" assessment of the
problem does not go far enough. For
example, it seems almost a paradox
that defense spending goes unchecked
while, at the same time, massive cuts
have been made in public health care
assistance programs as well as health
care research efforts. While public
fund-raising efforts may produce the
required resources to enable a young
child to receive a liver transplant or a
middle-aged person to obtain a heart
transplant, to date, thee remains rel-
atively little public debate over the
merits of increased defense expendi-
tures, which obviously pale current
health care expenditures.
Unfortunately, the lay public, nev-
ertheless, seems to be either unaware
of or has chosen to ignore the key
ethical issues implied by resource
allocation and rationing decisions.
Perhaps not uncharacteristically,
people remain willing to come to the
aid of identifiable victims of resource
scarcity, such as persons in need of
organ transplants. At the same time,
the lay public finds a special attrac-
tion in persons such as artificial heart
recipient Barney Clark, who has been
honored for "risking his life in order
to save it." Thus, in the end, perhaps,
the real concern with personal health
in today's society is not so much the
depersonalization and alienation that
many persons feel but rather the fact
that destructive forces of an unprece-
dented magnitude have served to com-
pletely threaten human existence.""*6
Consequently, for many people, the
true value of life becomes most appar-
ent either when a person's life is at
stake because they are denied medical
care that is available but in short
supply or when the type of medical
care required is unavailable. Al-
though often highly publicized by the
mass media, each of the patients who
fall into these categories serves to
underscore the basic dilemma-
health care resources are limited.
The inevitability of resource alldca-
tion and rationing decisions has been
well characterized by Fuehs.1" In his
discussion of the problems of health
and medical care, he notes that an
economic approach to these is firmly
rooted in three fundamental observa-
tions of the world. These are as
follows: (1) resources are scarce in
relation to human wants, (2) re-
sources have alternative uses, and (3)
people have different wants, with
considerable variation in the relative
importance they attach to them. Yet,
the basic economic problem identified
by Fuchs"' is "how to allocate scarce
resources so as to best satisfy human
wants."
While Fuchs places a great deal of
emphasis on the economics of re-
source allocation and provides only
cursory attention to the social, ethi-
cal, and legal implications of alloca-
tion and rationing decisions, the fact
is that without economic constraints,
most allocation and rationing deci-
sions would be unnecessary except in
situations in which the needed re-
source, natural or otherwise, is
severely limited. In instances of the
latter, economic resources would not
be sufficient to alleviate scarcity. The
basic premise of this discussion,
therefore, is that constraints on eco-
nomic resources will necessitate re-
source-allocation and rationing deci-
sions, which, in turn, will make the
confrontation of various social, ethi-
cal, and legal issues inescapable. In
the future, the major issues confront-
ing not only medicine but this society
as a whole will be the social, ethical,
and legal implications of resource
allocation and rationing, whether
framed in terms of distributive jus-
tice."'"'" discrimination against the
poor and disadvantaged,"1 or the
withholding of treatment from those
with catastrophic illness.1" All of
these share a common underlying
theme— the need to confront human
finality and purposeful existence."'
As described herein, the problems
associated with the allocation and
rationing of scare medical resources,
economic (eg, health care dollars) or
natural (eg, organs and tissue for
transplantation) are, indeed, related
to dying as an experience and death
as an event. This discriminatory use
of resources (and that is basically
what allocation and rationing imply)
has a lot to do with the fact that
persons are eventually denied some-
thing they require— in this case, med-
ical care. Schelling'" underscores the
essential ingredient of rationing deci-
sions when he distinguishes between
an "individual death/life" and a "sta-
tistical death/life." The two are, in
reality, different and he provides the
following example to illustrate his
point:
Let a 6-year old girl with brown hair need
thousands of dollars for an operation that
will prolong her life until Christmas, and
the post office will be swamped with
nickels and dimes to save her. But let it be
reported that without a sales tax the
hospital facilities of Massachusetts will
deteriorate and cause a barely perceptabje
increase in preventable deaths— not many
will drop a tear or reach for their check-
books.
This distinction is an important one
because it highlights the fact that the
death of a person is a unique, often
private event. Yet, at the local level,
the victim and his or her family have
an intense interest. In fact, as Schel-
ling1" notes, if society takes an inter-
est in a local death, it is often because
of a general concern that "reasonable
efforts are made to conserve life than
in whether those efforts succeed."
At this point in time, it is predict-
able that resource allocation decisions
are unlikely to be carefully scruti-
nized by the public until resource
rationing decisions become an ines-
capable fact of life. When the public
is exposed to rationing decisions that
it feels are contrary to the interest of
the persons involved, despite cata-
strophic illness, it is likely to call into >
question the worthiness of allocation t
decisions. When it becomes apparent «
that these decisions are based on a-'
mix of medical and social criteria, the
latter which the public is much more
likely to understand and despise as
the basis for differentially valuing
human life, the public will become
increasingly irritated and resentful.
While selection criteria of any sort
are likely to be viewed as unjust, it is
a truism that not all people are likely
to maximally or optimally benefit
from available medical technology.
For example, I and associates'0 have
shown how dramatically the exten-
sion of Medicare benefits to patients
with ESRD affected the composition
of the patient population. In particu-
2216 JAMA, April 22/29, 1983— Vol 249. No. 16
Health Care Technology — Evans
487
lar, indicia of patient rehabilitation,
such as employment status, show a
decline in the overall status of the
patient population.
In the future, decisions must be
made concerning which patients will
maximally and optimally benefit
from expensive health care technolo-
gy, yet a watchful person must focus
on such decisions to ensure that "so-
cial worth" will not be the criterion of
final determination. The problem,
however, is that, in many respects,
social and medical criteria are inex-
tricably intertwined. People of low
socioeconomic status are likely to be
in poorer health with multiple disease
conditions, which, in part, reflects
poor nutritional habits, detrimental
lifestyle, and the historical lack of
resources to obtain proper health
care. Consequently, if medical criteria
were to be the basis on which ration-
ing decisions are made, they might
exclude the poor and disadvantaged
because health and socioeconomic
status are highly interdependent. For
example, it is not unusual to find that
of those persons with ESRD, those of
lower socioeconomic status are likely
to have multiple comorbid health con-
ditions such as diabetes, hepatitis,
and hypertension. Not only are these
patients less desirable candidates for
dialysis and transplantation, but they
are among the more expensive pa-
tients to treat.
Without careful planning and eval-
uation, the cleavage between the
haves and have-nots, as evidenced by
formal selection criteria, is likely to
become substantial. Those with the
financial means may be able to pur-
chase the services they require, while
those who are disadvantaged and des-
titute will be denied care. Claims of a
right to health care might well serve
as a common goal to bind the disen-
franchised."162' '"; Specific laws have
been promulgated to protect the
rights of certain classes of persons;
examples include Section 504 of the
Rehabilitation Act of 1973, the Age
Discrimination Act, and Title VII of
the Civil Rights Act. Each of these
laws has important implications for
resource rationing decisions.
It is highly probable that disclosure
of the names, by the media, of persons
who have been denied the benefits of
medicine will set into motion complex
sociopolitical manuevering to re-
prieve those who have reportedly
been treated unjustly by those with
authority to make and enforce re-
source-rationing decisions. Argu-
ments that surround these decisions
are likely to be similar to those
made in connection with abortion and
the withholding of medical treat-
ment s The Quinlin, Saike-
wicz, and Dinnerstein cases will fre-
quently be cited as precedent setting.
Analogies are likely to be made
between current events and the
events that took place in Nazi Germa-
ny. To this end, it will be argued that
to set forth criteria that deny people
treatment, in effect, represents a
devaluation of life. As Carroll1"* has
noted:
Life has become increasingly cheap in our
time. Today, Auschwitz and Dachau are
museums; Coventry, Dresden, and Hiro-
shima, vague memories; the deaths several
years ago of hundreds of thousands of
Indonesians, a footnote to history; race
riots in American cities, a subject of study;
and war casualties in Viet Nam, an object
of routine reports.
Moreover, the practice of rationing
will bring forth cries that the prece-
dent is now set for the "floodgates to
be opened" to the "mass slaughter" of
persons whom rationing criteria de-
clare to be of "marginal" value
The point of the matter, however, is
that rationing decisions are already
being made.'2' The fact that they are
not publicized has prevented them
from becoming a social issue, despite
the fact that they have attracted the
attention of bioethicists.212' ' m Nev-
ertheless, the future is likely to be
filled with accounts of persons who
have been refused treatment. Within
a society that has failed to come to
grips with the meaning of death and
the essence of life, rationing decisions
will seem unusually cruel. Yet, when
these decisions are acknowledged as
inescapable, this society, this culture,
will be more prepared to deal with the
one event that is truly inevitable-
death.
This is pari 11 of a two-part article. Part
I app* ared in the April 15 issue.
Preparation of this article has been made
possible by grant 95-P-97887/0-0) and contract
500-81-0051, provided by the Health Care
Financing Administration.
I received assistance from Christopher R.
Biagg, MD, George I,. Maddox, PhD, Carl
Josephson, and the entire health care technology
assessment team at the Battelle Human Affairs
Research Centers. Millie Gregory typed the
manusrript and Peg Nadler provided editing
assistance.
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Health Care Technology — Evans 2219
490
Mr. Gore. Thank you very much, Doctor.
Our final witness today is John McCabe, legal counsel to the Na-
tional Conference of Commissioners on Uniform State Laws. Wel-
come.
Mr. McCabe. Thank you, Mr. Chairman.
I will make my testimony short because I think my position here
mainly is at the invitation of the committee, to listen to what has
transpired here and to ultimately take the committee's recommen-
dations, so I can better advise my governing body with respect to
any changes we may wish to make in the Uniform Anatomical Gift
Act, or with respect to any other uniform acts that may be pro-
posed.
We are the source of the Uniform Anatomical Gift Act and the
Uniform Determination of Death Act, both of these acts we think
having a significant impact or supposed to have significant impact
upon organ donation and organ donation procedures. So, we have a
significant interest in this area on behalf of State government.
We would be very hopeful that this committee would address its
recommendations not only to the questions of Federal legislation,
but to the questions of what might be applicable at the State level,
what types of legislation, what types of legislative change ought to
be made at the State level, knowing that that is frequently beyond
the general concerns of committees of the Congress.
I say that because although we are an institution of State gov-
ernment, we are a very small body and a very under-resourced
body. Your committee, with the people that it has brought before it
and with the information that it is creating, has a much better op-
portunity to survey the issues and to come up with concise and, I
would hope, comprehensive recommendations.
Beyond that, I would like to simply address a moment the legis-
lative questions, it seems to me, that may arise in general with re-
spect to changing or replacing the Uniform Anatomical Gift Act.
It is a bit of an irony, it seems to me, in a good deal of this.
Going back to 1968, when we did the Anatomical Gift Act, we es-
sentially extracted from a very confusing pattern of State statutory
law and common law a voluntary system of organ donation.
Emphasis must be placed upon the voluntarism of the act. We
created individual autonomy over the donation process over the de-
cision not to donate, if that is what the individual decided to do.
Having done that, if there are now to be recommendations to
somehow come back from that level of voluntarism, then I think
we have a considerably different legislative task before us.
We have the task of coming up with appropriate language to
deal with such things, presumably as presumptions, to opt out
somehow enforceable choices to be made when people sign certain
documents. We have those kinds of technical questions to address,
but we also have considerable political questions to address.
The irony is that before 1968 we might have been able to do
something with opt out or presumption when the law was a good
deal more confused than it is now. But we have placed individual
autonomy with respect to these decisions in the law in every State
in the United States.
If we now go to the States and say we are going to change that,
we must have a substantial record validating that decision and
491
validating to the State legislatures — all 50 of them, plus the Dis-
trict of Columbia, plus Puerto Rico, plus the Virgin Islands, all of
whom respond to my organization — reasons for those changes.
We must also come to them with a coalition of support, a signifi-
cant enough consensus from the groups that support these issues,
so that we can convince the State legislatures that the Anatomical
Gift Act either needs to be significantly changed or needs to be re-
placed.
I am sure all of you have large collective legislative experience,
clearly in this body and I suspect also in your own States. That is
the general rule with regard to members of Congress. So you un-
derstand the problems of dealing with the 50 different state legisla-
tures and the difficulties of the legislative process.
If there is to be change, if there is to be proposed change, we
need two things: one, we have to have that coalition, we have to
have that record to establish, to validate the reasons for change;
and two, I think we have to stay as close to the voluntary approach
as we can.
Thank you.
Mr. Gore. Thank you very much. That is quite helpful.
[The prepared statement of Mr. McCabe follows:]
492
Statement of John M. McCabe Legislative Director
National Conference ot Commissioners on Uniform Slate Laws
MS N.mUi Mn.-hijj.in \M-iuK-. Suilc 5 H). Chicago. Illinois t.Of. ] I -(312)321-971(1
John M McCabe
Legislative Director
April 5, 1983
Representative Albert Gore, Jr.
Chairman, Subcommittee on
Investigations and Oversight
Committee on Science and Technology
Suite 2321, Rayburn House Office Building
Washington, DC 20515
Dear Representative Gore:
I am pleased to represent the National Conference of
Commissioners on Uniform State Laws (NCCUSL) before the
Committee on Science and Technology on April 14, 1983, at
the Committee's request. As I understand my role, from_.
the letter of invitation and from discussions with the
Committee staff, it is to monitor the Committee proceed-
ings and to react to possible proposals for new state leg-
islation on organ donation. The Committee's invitation was
prompted by the historic impact of the Uniform Anatomical -
Gift Act, promulgated by the NCCUSL in 1968.
Insofar as I can fulfill that role, I shall be glad to
do so. Certainly, I will be pleased to report the Committee's
findings to the NCCUSL. However, I want to disclaim, ini-
tially, that I have any power to commit the NCCUSL to any
position or to any action on any issue presented in these
hearings.
As an initial matter, I would like to present a short
summary of the developments leading to the promulgation and
adoption of the Uniform Anatomical Gift Act. The NCCUSL
records indicate that the first suggestions made to the
NCCUSL for a Uniform Act pertaining to organ donation came
from the National Pituitary Agency in 1965. After approval
as a subject suitable for development as a Uniform Act, it
493
Rep. Albert Gore, Jr.
April 5, 1983
Pa.je Two
was assigned to a Drafting Committee chaired by E. Blythe
Stason, Professor and Dean Emeritus at the University of
Michigan Law School. The records indicate that Dean Stason
(now deceased) was a guiding force in the development of the
Act. A first draft appeared in 1966.
The Drafting Committee activity soon received enormous
input and support from the medical community. Drafts were
widely circulated. The National Institute of Health pro-
vided advisors to the effort. In 1968, Dean Stason appeared
before a subcommittee of the U.S. Senate, chaired by' then
Senator Mondale, to present the developing Act, All of these
activities led to almost universal support for the Act from
the medical and legal communities when the Act was promulgated
in August, 1968. The Act received nearly simultaneous approval
by the American Medical Association, for example.
The level of support was so great that the Act was uni-
formly adopted by every state except Kentucky by 1971. .Ken-
tucky joined the list of adopting states by at least 1977.
In terms of achieving uniformity, this Act moved through the
legislatures with great rapidity.
The Uniform Anatomical Gift Act has only one objective.
It extracts from the confused character of the common law a
definite power in each individual, by execution of a proper
instrument, to donate parts of the body, after death, to
medical institutions. The individual has complete autonomy
in making any such donation, or in withdrawing it. Simpli-
fied forms are suggested, and, as the members of the Committee
are probably aware, many states have incorporated the simpli-
fied forms into regularly issued documents, such as drivers'
licenses .
It is important to recognize that the appeal of this
Act was very much grounded in its voluntary character. Al-
though drafted in the context of increased demand for trans-
plantable organs, the Act's principal concern is individual
autonomy over decisions made about the body after death.
Many commentators believed, or hoped, that individual auton-
omy would increase the supply of transplantable organs, as
people chose to execute donor instruments. If that hope has
not been met, it must be remembered that the character of
this Act made the supply of transplantable organs an implied
and tertiary goal, from the beginning. And the problem of
23-029 0-83-32
494
Rep. Albert Gore, Jr,
April 5, 1983
Paye Three
any change in the future will be that of subordinating
individual autonomy, now clearly granted everywhere, to a
primary goal of increasing the supply of transplantable
organs. The political stakes will be far different from
those wagered in the earlier effort to obtain and enact the
Anatomical Gift Act.
Given that preliminary introduction to the Uniform
Anatomical Gift Act, I would conclude by describing to
the Committee the procedures of the NCCUSL for drafting a
Uniform Act. The NCCUSL has a Standing Committee, called
the Scope and Program Committee, that is responsible for
considering subjects for new Uniform Acts and for consider-
ing amendments to existing Uniform Acts. The Scope and
Program Committee reports its recommendations to the NCCUSL
Executive Committee twice a year. If the Executive Com-
mittee approves drafting work, its recommendations must be
approved by the NCCUSL membership at the Annual Meeting of
the organization. Upon that approval, a Drafting Committee
is appointed by the NCCUSL' President . A Drafting Committee
works a minimum of two years in preparing the proposed Act.
Each Act must receive at -least one preliminary reading and
one final reading at an Annual Meeting. If the membership.
of the NCCUSL is satisfied with the draft at the final read-
ing, it is subjected to a "vote by states." Each state's
Uniform Law Commission caucuses on the promulgation of each
Act. Each state has one vote. A majority of the states
allows official promulgation of the Act. This is the se-
quence through which every official Uniform Act must pass.
Of course, official promulgation does not mean instant
acceptance in the state legislatures. The NCCUSL proposes,
but the state legislatures dispose. Achievement of uni-
formity, generally, requires a substantial coalition of
groups supporting the same legislation. Hopefully, any
legislative effort will not face a great deal of opposition,
for opposition retards or prevents legislative enactment. If
adequate support can be generated, uniformity becomes possible
Having made these preliminary comments , I am at the
Committee's disposal during the hearing on April 14.
Sincerely ,
LOohn M. McCabe
Legislative Director
J MM : cms
495
Mr. Gore. Dr. Wiecking, you were involved in legislation that
was proposed in Virginia a few years ago to permit direct salvage
of usable organs by medical examiners. This seems similar to what
you testified has been enacted in some States. Yet in Virginia this
recently generated an enormous public furor.
I have here a copy of an article from the Washington Post, refer-
ring to this as the Harvest of the Dead" bill. Would you comment,
please?
Dr. Wiecking. This was an attempt to permit the taking of a
very small organ called the pituitary gland, and nothing else, deep
inside the body. It was suggested by the pituitary-endocrine medi-
cal group because they needed to get the hormone to help dwarfs
grow.
This was strongly opposed in the Virginia General Assembly by a
certain religious group and by a libertarian group. Therefore, it
was not enacted. In my opinion, if an obscure organ like the pitu-
itary creates such a ruckus, I suspect it will be even more so with
other, more visible organs.
Mr. Gore. This was only with respect to pituitary glands exposed
during the process of autopsy. Is that correct?
Dr. Wiecking. Yes, sir.
Mr. Gore. And the public furor was enough to defeat that at the
State level.
Dr. Wiecking. From two groups, yes, sir.
Mr. Gore. It was the American Civil Liberties Union and Ortho-
dox Jews, correct?
Dr. Wiecking. Yes, sir.
Mr. Gore. Mr. McCabe, would there be problems with a manda-
tory checkoff as a halfway measure without going to a presumed
consent? What do you think about that, a mandatory checkoff with
a yes, no, undecided?
Mr. McCabe. I would say something along those lines would
probably more preferable, again, based on what we have now,
which is a very voluntary system and a system which we created
out of that early chaos of the common law. It wasn't clear before
who owned the body and exactly what relationship that body had
between the individual and society. There is not much doubt now.
So, I think if you are going to tell the States that they are going to
have to make a change, an incremental change, the less change
that you can offer, the better chance you have of doing something
with it.
It seems to me the checkoff system, or a system that provides
less than the opt out type of system, might indeed have a better
legislative chance, although it seems to me there are some critical
questions to be addressed in that.
How do you enforce the checkoff system? What does it mean if
an individual refuses to check off either yes, no, or maybe or what-
ever? How do you mandate that sort of thing in a way that will be
acceptable, among others, to civil libertarians?
I think there are some questions with respect to that kind of an
issue, too. Again, the closer you stay to the voluntary existing
system, I think the better chance you have for doing something.
Mr. Gore. Dr. Evans, I understand that you have extensively ex-
amined the organ procurement agencies involved in obtaining
496
organs, especially hearts, in addition to closely examining the cur-
rent organ donation practices, which you have described.
You were also present during yesterday's hearings, and I am in-
terested in whether or not you would agree with the characteriza-
tion of the Nation's organ procurement effort that we heard yester-
day. Do you think it can be made more efficient, more fair, more
effective, more rational?
Dr. Evans. I certainly think that improvements can be made. I
think the nice thing to see is that people are attempting to do that.
The idea of expanding the Seopf system, the Southeastern Organ
Procurement Foundation's computer network, is a realistic kind of
thing which could be implemented on a larger scale.
Mr. Gore. You think that would be a productive step?
Dr. Evans. Indeed, I think that it would be a very productive
step. Of course, as the problems were pointed out with extra-renal
organs, there is a significant time problem in terms of how long
that organ can be outside the human body. Provided major develop-
ments are made with regard to storage, a computerized system
would become even more important.
Even given testimony yesterday and things that we have found,
there is a fair amount of cooperation out there among the existing
programs. There is room for improvement. I think everybody would
acknowledge that.
Mr. Gore. Thank you very much.
Congressman Reid?
Mr. Reid. Chairman Gore, I have no questions.
Mr. Gore. It has been a long 2 days. We have one day remaining
in these hearings, but it will not be until April 27. The Surgeon
General and others from the Federal administrative agencies will
testify at that time.
I would like to particularly thank the members of this final
panel for their patience and indulgence. I would like to thank all of
the witnesses that have appeared during these hearings.
We will stand adjourned until April 27, when we will take this
matter up again in the third day of hearings. Thank you.
[Whereupon, at 1:30 p.m. the subcommittee adjourned, to recon-
vene Wednesday, April 27, 1983.]
ORGAN TRANSPLANTS
WEDNESDAY, APRIL 27, 1983
House of Representatives,
Committee on Science and Technology,
Subcommittee on Investigations and Oversight,
Washington, D.C.
The subcommittee met, pursuant to recess, at 9:35 a.m., in room
2325, Rayburn House Office Building, Hon. Albert Gore, Jr. (chair-
man of the subcommittee) presiding.
Present: Representatives Gore, Volkmer, Reid, and Skeen.
Mr. Gore. The subcommittee will come to order.
I would like to welcome all of our guests and witnesses. I have an
opening statement, and then we will proceed with our first panel.
This morning the subcommittee continues its third and last in
this series of scheduled hearings to evaluate the national system of
obtaining and allocating human organs for transplant surgery.
At our opening session 2 weeks ago, the subcommittee heard
compelling and at times heart-rending testimony describing the in-
adequacies of the effort nationwide to stimulate voluntary organ
donation in order to obtain enough organs to meet the demands for
this often life-saving surgery.
There was no more eloquent testimony explaining the problems
we are examining here today than the statement of Mrs. Billie
Hall, whose son Brandon underwent the first of two lengthy liver
transplant procedures directly after the hearing. Mrs. Hall told us,
"We have got ours. With God's help, we are going to make it. But
there are so many here who might not."
The fact that Brandon Hall was able to obtain organs for two
transplants in the past 2 weeks demonstrates that transplantable
organs are available and that public and private programs must
seek to improve donor awareness and establish better networks to
link donors and those who will benefit from the surgery.
I might say, parenthetically, for those in the hearing room who
were here when Mrs. Hall testified, that we got a brief update this
morning on Brandon Hall's condition. It is listed as stable. I visited
him Sunday, and he is improving right along, or appears to be. His
doctors are the ones who should make any statement about that.
But he certainly is doing quite well.
The condition of the second child in the same hospital, however,
awaiting a transplant is now judged critical, and an urgent search
for a liver donor is underway for that child.
We heard during the previous hearings about private sector ef-
forts to enhance organ donation and to coordinate organ allocation.
What is being done to enhance the collection of organs by the Fed-
(497)
498
eral Government? We will hear about some of these efforts today.
There will, we hope, be some good news, but some questions will be
raised as well.
For example, one Federal effort to enhance organ donation was
conducted in Georgia hospitals in the late 1970's by the Centers for
Disease Control. Over a 2V2-year period, the CDC effected a dra-
matic, almost nine-fold, increase in usable kidneys retrieved.
This program was hailed by the AMA Council of Scientific Af-
fairs, who urged support for its promotion and nationwide develop-
ment. A proposal to expand the program and establish five demon-
stration projects was estimated to yield 500 additional kidneys per
year, with an estimated cost savings of $25 million to $28 million
for 3 years and $169 million to $200 million over 10 years.
Yet, we were informed that the CDC was forced to terminate this
effort in 1979. What are the reasons for this? I hope today's wit-
nesses from the Department of Health and Human Services can
help to answer this question for us.
We also heard some very disturbing testimony during our previ-
ous 2 days of testimony. Witnesses told the subcommittee that po-
tentially life-saving techniques, such as liver transplants, are
simply not available to many because they are considered "experi-
mental" and therefore not reimbursable under various government
medical programs, both civilian and military.
It is not easy to forget — nor do we want to forget — the testimony
of Capt. John Broderick about his 2-year-old daughter, Adriane,
who could not get a much-needed liver transplant because the
Army's medical insurance program, CHAMPUS, would not reim-
burse for the surgery.
The subcommittee has received numerous letters and pleas from
others with stories as compelling and troubling as that of Captain
Broderick and his daughter.
So, today, we will continue our examination of the programs es-
tablished to obtain organs for transplant surgery, but we will also
shift our focus somewhat and examine more closely why Captain
Broderick has been unable to get the Army to pay for his daugh-
ter's transplant and why civilians coming under other Federal pro-
grams face similar hurdles. These are important questions because
many private insurance carriers look to the Federal programs for
guidance.
To get answers to our questions, we are privileged to have distin-
guished representatives from the two primary Federal agencies in-
volved in these issues, the Department of Health and Human Serv-
ices and the Department of Defense. We will be asking these agen-
cies two principal questions. We will ask these questions primarily
about liver transplants, but the questions have far broader implica-
tions.
The questions are: one, how does a new technology, such as liver
transplants, go from being considered experimental and nonreim-
bursable to being efficacious and available to all, regardless of their
ability to pay? No. 2, how can new life-saving techniques, which
have been demonstrated to be effective, yet may still be considered
experimental, be made available to those in need who cannot
afford to pay for them?
499
We look forward to a lively discussion of these issues. Hopefully,
there will be some progress toward achieving uniformity in deliv-
ery of such vital services and valuable suggestions to improved
organ procurement and allocation.
I would like to recognize the ranking minority member of the
subcommittee, Congressman Skeen.
Mr. Skeen. Thank you, Mr. Chairman.
I have no extensive opening statement. I just want to welcome
the panel here. I think these discussions have been extremely sig-
nificant, and I think they have contributed a great deal to the
public view of what organ transplant technology is all about, the
progress that has been made, and where do we go from here in de-
ciding what are the ethics involved in this discussion.
I think, once again, that this has been a very significant series of
hearings. I want to commend the chairman. But, particularly, I am
interested in what today's witnesses have to say.
Thank you very much, Mr. Chairman. We will get into the testi-
mony.
Mr. Gore. Thank you very much.
We are particularly honored that the distinguished individuals
on this first panel have demonstrated their willingness to come and
share in this effort.
Dr. Edward Brandt is Assistant Secretary for Health in the De-
partment of Health and Human Services. Dr. Carolyne Davis is Ad-
ministrator of HCFA in HHS. Of course, Dr. C. Everett Koop is the
Surgeon General of the United States and Assistant Secretary for
Health with the Public Health Service. Dr. John F. Beary, III, is
acting Assistant Secretary of Defense for Health Affairs in DoD.
These witnesses are accompanied by, on the part of Dr. Davis,
Dr. Donald Young, who is, I think, with you and will be prepared
to answer questions if necessary. Dr. Beary is accompanied by Dr.
Alexander Rodriguez, Medical Director of CHAMPUS, and Robert
Gilliat, Assistant General Counsel for Manpower and Health Af-
fairs with DoD.
In accordance with the wishes of the panel, we are going to rec-
ognize you in the following order: Dr. Brandt, Dr. Davis, Dr. Koop,
and Dr. Beary.
Dr. Brandt, without objection, the entire text of your statement
and those of the other witnesses will be included in the record in
full during the hearings. If you care to summarize any portion of
your statement, feel free to do so. If you wish to present it all, that
is fine, too. Please proceed.
STATEMENT OF EDWARD N. BRANDT, JR., M.D., ASSISTANT SEC-
RETARY FOR HEALTH, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Brandt. Thank you very much, Mr. Chairman. I will summa-
rize my statement.
I would like to ask first if we could change the order briefly to
have Dr. Koop follow me, since it fits right in and expands on a
portion of my testimony.
Mr. Gore. Surely. That is, I think, most appropriate, and we will
handle it precisely that way.
500
Dr. Brandt. Thank you, sir.
It is a pleasure to appear before you today to discuss the work of
the Public Health Service in organ transplantation. The issues you
have discussed in this set of hearings are important and have obvi-
ous life-saving implications.
In my testimony, I will describe for you the part the Public
Health Service has played and continues to play in organ trans-
plantation and related areas.
Much of the work of the Public Health Service deals with the de-
velopment of new knowledge in the biomedical sciences to improve
our understanding of disease: its progression, its treatment, and its
prevention. This research is conducted mainly at the National In-
stitutes of Health and the Alcohol, Drug Abuse and Mental Health
Administration .
In addition, as you know, we have responsibility for assurance of
public health and safety through the regulation of drugs and de-
vices used in the diagnosis and treatment of disease. I shall discuss
this aspect in more detail later in relation to Cyclosporin A, which
is a new drug which has increased the efficacy of transplant sur-
gery.
Third, the surveillance and prevention of public health problems
are the responsibility of the Public Health Service, particularly the
Centers for Disease Control.
Finally, when asked by the Health Care Financing Administra-
tion, we do assess the safety and efficacy of new procedures in
order to help HCFA make coverage decisions.
The aim of our basic and clinical research is to develop proce-
dures for the most effective selection of recipients of grafts; to de-
velop optimal procedures to condition the recipient prior to trans-
plantation in order to minimize the risk of rejection; to identify
those factors that trigger the rejection of transplant; and to develop
ways in which to prevent and treat rejections.
Highlights of the NIH research include the work on cyclosporin
A which, although new, is reportedly much more effective than
older immunosuppressant drugs. Additionally, NIH is funding re-
search on multiple pre-transplant blood transfusions, which have
been shown to enhance renal graft survival rates up to 60 percent,
a significant prevention of early graft failure.
Furthermore, sufficient data and sophisticated analytic tech-
niques are now available for renal and bone marrow transplanta-
tion to permit accurate identification and estimation of the relative
importance of risk factors and therapeutic strategies. We can now
predict probable outcomes for individual patients and for particular
populations with those two grafts.
The accomplishments to date are promising. At least three trans-
plantation procedures are established features of clinical practice
today: cornea transplants, kidney transplants, and, for some condi-
tions, bone marrow transplants.
While the use of cyclosporin A is reported to be of major impor-
tance in improving the survival of patients with kidney, liver, or
heart transplants, we must recognize that the post-operative prob-
lems are very real. Whether children with liver transplants will
grow normally, what survival rates after a year or two will be,
501
what the long-term risks are with respect to cancer and repeated
infections are all questions for the future.
We will need to rely on future research to address three very im-
portant problems. First, our knowledge of tissue typing remains in-
complete. A second area requiring further study is the problem of
rejection. Better drugs are clearly needed that can be targeted to
specific immune systems rather than suppressing the entire
immune system of the body.
Third, more work is needed in the area of organ preservation.
The state of the art in liver transplantation has been advancing
so rapidly that data is only now beginning to evolve about the pro-
cedure. NIH has invited the leading researchers and practitioners
in the field to share their data and experiences at a Consensus De-
velopment Conference on Liver Transplantation to be held in June
of this year.
The purpose of this conference is to address the following ques-
tions:
Are there identifiable groups of patients for whom transplanta-
tion of the liver should be considered appropriate?
In terms of current survival rates, complications, and other out-
come criteria, how do these various groups fare?
What are the principles guiding selection of the appropriate time
for surgery in potential candidates for transplantation?
What are the skills, resources, and institutional support needed
for liver transplantation?
And, what are the directions for future research?
The new immunosuppressant drug, cyclosporin A, has been used
in combination with adrenal corticosteroids to prevent organ rejec-
tion in kidney, liver, and heart transplants. Initial review suggests
that cyclosporin A has dramatically increased success rates of
kidney and liver transplants, while modestly affecting the success
of heart transplants.
The drug now is in the final stages of the review process for ap-
proval by the FDA.
As transplant science and technology efforts succeed, issues relat-
ed to organ procurement and service delivery become more promi-
nent. I believe you should know that the Public Health Service
plays a role in the area of organ procurement as well.
The shortage of donated kidneys has not shocked the Nation's
conscience because hemodialysis can keep patients alive while they
await a transplant. However, the lack of a heart or liver for trans-
plantation may mean death.
The Centers for Disease Control, as you pointed out, developed
an approach to organ procurement using public health principles
in order to demonstrate how to increase the number of organs pro-
cured, and their demonstration, Mr. Chairman, resulted in a three-
fold, rather than a ninefold, increase in the number of kidneys
available for transplantation on an annual basis.
It was demonstrated that by applying a more systematic and
timely approach to identifying potential donors, the number of
organs actually procured could be increased. They developed a
system involving a number of procedures which are detailed in the
complete testimony.
502
The results of this demonstration have been widely disseminated
in the professional literature, and the CDC has provided, and con-
tinues to provide, technical assistance to procurement centers in-
terested in increasing organ availability.
Dr. Koop will sponsor a workshop in June to focus attention on
the need and to explore measures to increase the availability of
organs for transplantation.
The Office of Health Technology Assessment within the National
Center for Health Services Research has been asked by HCFA to
evaluate the safety and effectiveness of heart, pancreas, and liver
transplants.
Public Health Service assessment of the heart transplant has
been suspended until the Battelle Center National Heart Trans-
plantation Study is completed in April and a report submitted in
July.
In April of 1982, HCFA asked us to reassess liver transplanta-
tion. As is our usual practice, we published a notice in the Federal
Register about our intent to evaluate these technologies and, at the
same time, contacted appropriate Federal agencies, medical special-
ty societies, and health insurance and manufacturing associations.
With material from these sources, information that the NIH Con-
sensus Development Conference on Liver Transplantation gener-
ates, and staff review of the literature, the Office of Health Tech-
nology Assessment will develop PHS recommendations regarding
the safety and effectiveness of liver transplantation for usual cir-
cumstances in the practice of medicine for HCFA's use. The results
of the liver assessment should be available sometime this summer.
Various agencies of the Public Health Service are active in
trying to address many of the concerns voiced before this subcom-
mittee. In describing our activities, I have outlined the role we play
in research and drug regulation, in public health surveillance and
conscience raising, and in technology assessment.
I can assure you that all of these efforts, including those to devel-
op knowledge and explore new treatments, will continue in the
hope that, ultimately, research will identify the cause and progres-
sion of these diseases, thus, in the future, preventing the need for
organ transplantation.
[Prepared statement of Dr. Brandt follows:]
503
STATEMENT
by
EDWARD N. BRANDT, Jr., M.D.
ASSISTANT SECRETARY FOR HEALTH
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Mr. Chairman and Members of the Subcommittee:
It is a pleasure to appear before you to discuss the work of the
Public Health Service in organ transplantation. I am Dr. Edward N.
Brandt, Jr., Assistant Secretary for Health, Department of Health and
Human Services. With me is Dr. C. Everett Koop, the Surgeon General of
the Public Health Service. Dr. Carolyne Davis, Administrator of the
Health Care Financing Administration (HCFA), will also be discussing the
activities of her agency.
The issues you have discussed in this set of hearings are important
and have obvious life saving implications. No one who has followed the
hearings and the stories of Jamie Fiske and Brandon Hall can fail to be
moved by the ordeal of children waiting for an organ transplant. In my
testimony, I will describe for you the part the Public Health Service has
played and continues to play in organ transplantation and related areas.
Much of the work of the Public Health Service (PHS) deals with the
development of new knowledge in the biomedical sciences to improve our
understanding of disease: its progression, its treatment, and its
prevention. This research is conducted mainly at the National Institutes
of Health (NIH) and the Alcohol, Drug Abuse and Mental Health
Administration (ADAMHA) . In addition, we have responsibility for
504
assurance of public health and safety through the regulation of the drugs
and devices used in the diagnosis and treatment of diseases. As you
know, the Food and Drug Administration is the principal agency
responsible for this activity. I shall discuss this in more detail later
in relation to Cyclosporin A, the new drug which has increased the
efficacy of transplant surgery. Third, the surveillance and prevention
of public health problems are the responsibility of the Centers for
Disease Control (CDC). CDC has also made contributions to the area of
organ transplantation as has the Office of the Surgeon General. Finally,
when asked by HCFA, we assess the safety and effectiveness of new
procedures in order to help HCFA make coverage decisions. The Office of
Health Technology Assessment (OHTA) at the National Center for Health
Services Research serves this function for the PHS.
The Development of New Knowledge
The National Institutes of Health supports basic research on
transplantation as well as organ-specific research on the heart, heart
and lungs, kidneys, liver, and pancreas. In addition, the NIH supports
research on other transplantable tissues, including corneas, bone and
cartilage, bone marrow, and skin. The aim of this basic and clinical
research is to develop procedures for the most effective selection of
505
recipients of grafts; to develop optimal procedures to condition the
recipient prior to transplantation in order to minimize the risk of
rejection; to identify the factors that trigger the rejection of
transplants; and, to develop ways in which to prevent and treat
rejection. Vfe look to this research to increase our understanding of
transplantation and to develop improved techniques of immunosuppression
that will enhance graft survival and function, as well as reduce
complications that lead to graft rejections.
The major NIH Institutes involved in organ transplantation research
are the National Institute of Allergy and Infectious Diseases; the
National Heart, Lung, and Blood Institute; and the National Institute of
Arthritis, Diabetes, and Digestive and Kidney Diseases. In Fiscal Year
1982 these three Institutes combined supported approximately 230 projects
at a funding level of about $36 million on organ transplantation research.
Highlights of the NIH research include the work done on Cyclosporin
A, which, although relatively new, is reported to be much more effective
than older immunosuppresive drugs in increasing survival rates in a wide
variety of transplanted organs including the kidney, liver, and
pancreas. Additionally, NIH is funding research on multiple
pretransplant blood transfusions — shown to enhance renal graft survival
rates up to 60 percent — a significant prevention of early graft failure.
506
Furthermore, sufficient data and sophisticated analytic techniques
ate now available for renal and bone marrow transplantation to accurately
identify and estimate the relative importance of risk factors and
therapeutic strategies. We can now predict probable outcomes for
individual patients and for particular populations. Thus, more effective
tools for patient counseling and for better informed and more objective
allocation of public resources can be utilized.
The accomplishments to date are promising. At least three
transplantation procedures are established features of clinical practice
today — cornea and kidney transplants and, for some conditions, bone
marrow transplants. In 1981, approximately 4,500 transplants of kidneys
and 600 of corneas were performed. Advances in immunology and the
experimental use of Cyclosporin A have extended the application of
transplant technology to the heart, heart-lungs, the pancreas, and the
liver. Over the past year, transplants of some 80 livers, and 10-15
pancreases, more than 100 heart transplants, and about 11 heart and lung
transplants have been performed.
While the use of Cyclosporin A is reported to be of major importance
in improving the survival of patients with kidney, liver, or heart
transplants, we must recognize that the post-operative problems are very
507
real. Whether children with liver transplants will grow normally, what
survival rates after a year or so will be, what the long term risks are
with respect to cancer and repeated infections are all questions for the
future.
We will need to rely on future research to address three very
important problems. First, our knowledge of tissue typing remains
incomplete. This is especially so for certain minority populations for
whom tissue typing techniques are still inadequate. A second area
requiring further study is the problem of rejection. Our current
armamentarium of drugs is not without threats of cancer and toxicity to
the kidney. Better drugs are needed that can be targeted to specific
immune systems rather than suppressing the entire immune system of the
body. Consequently, we will be looking to basic research in molecular
biology to explore the nature of cell surfaces and receptor sites for
answers to these questions. Third, more work is needed in the area of
organ preservation. Currently, hearts can only be preserved for up to 4
hours, livers for 10 hours, and kidneys for 72 hours. If techniques of
organ preservation could be improved, the problems of organ availability
could be greatly diminished. Answers to these questions could
significantly affect the success of organ tranplantation.
508
The state-of-the-art in liver transplantation has been advancing so
rapidly, that data is only now beginning to evolve about the procedure.
NIH has invited the leading researchers and practitioners in the field to
share their data and experiences at a Consensus Development Conference on
Liver Transplantation to be held in June of this year. The purpose of
the conference is to address the following questions:
o Are there identifiable groups of patients for whom
transplantation of the liver should be considered appropriate
therapy?
o In terms of current survival rates, complications, and other
outcome criteria, how do these various groups fare?
o What are the principles guiding selection of the appropriate
time for surgery in potential candidates for transplantation?
o What are the skills, resources, and institutional support
needed for liver transplantation?
o VJhat are the directions for future research?
509
Regulation of Drugs
As I mentioned earlier, the new immunosuppressant drug, Cyclosporin
A, has been used in combination with adrenal corticosteroids to prevent
organ rejection in kidney, liver, and heart transplants. Its usefulness
in lung and pancreatic transplants is also being investigated. Initial
review suggests that Cyclosporin A has dramatically increased success
rates of kidney and liver transplants, while modestly affecting the
success of heart transplants. Because of the promising results generated
by clinical testing of the drug, the FDA has given it a high priority for
review and the drug now is in the final stages of the review process.
On March 25, the FDA. Oncologic Drug Advisory Committee recommended
approval of the use of Cyclosporin A with adrenal corticosteroids.
Subsequently, the sponsor has corresponded with the FDA regarding the
application and discussions are now underway about certain tecnnical
issues.
Surveillance and Prevention of Public Health Problems
As transplant science and technology efforts succeed, issues related
to organ procurement and service delivery become more prominent. In
addition to supporting research and insuring safe and effective drugs, I
23-029 0-83-33
510
believe you should know that the Public Health Service plays a role in
the area of organ procurement as well. The shortage of donated kidneys
has not shocked the nation's conscience because hemodialysis can keep
patients alive while they await a transplant. However, the lack of a
heart or liver for transplantation may mean death, res>-ting in desperate
appeals by parents for livers, for example, without which their children
would die.
The Centers for Disease Control (CDC) in the late 1970 's developed
an approach to organ procurement using public health principles in order
to demonstrate how to increase the number of organs procured. This was
done in response to the perceived cost-effectiveness of transplantation
and the improved quality of life for transplant recipients, together with
the shortage of cadaveric organs available for transplantation.
A study was initiated to assess the number of kidneys potentially
available for transplant purposes. Medical records of deceased patients
were reviewed using criteria developed by transplant surgeons for
determining suitability of organ donors. These record reviews
demonstrated that only a small proportion of suitable donors were
actually being identified within the short time available to accomplish
organ procurement.
511
It was also demonstrated that by applying a more systematic and
timely approach to identifying potential donors, the number of organs
actually procured could be increased. In a demonstration in Atlanta and
Augusta, Georgia, CDC tripled the number of kidneys procured in a
three-year period by implementing the following procedures:
o Instituting a procurement program in those hospitals which had
been identified by record review as having potential donors.
o Making use of an existing operational procurement apparatus,
consisting of surgeons, tissue typers, transplant coordinator,
and the like.
o Establishing professional education to promote and maintain
program visibility.
o Making daily visits to the hospital and the specific units to
identify potential donors.
o Assessing the program's effectiveness by monitoring medical
records to determine the number of potential donors and the
number of donors actually being referred,- to quickly identify
where potential donors were being missed; and to understand the
dynamics of the individual hospital.
512
The results of CDC's demonstration efforts have been disseminated in
the professional literature and the CDC staff has provided technical
assistance to procurement centers interested in increasing organ
availability. The CDC results also have applicability in identifying
potential donors of many types of organs. Mditionally, to underline the
need f-jr increased efforts in this area, the President has asked
Dr. Koop, Surgeon General of the Public Health Service and a pediatric
surgeon, to provide help in stimulating organ donation. To this end,
Dr. Kbop will sponsor a workshop in June to focus attention on the need
and to explore measures to increase the availability of organs for
transplantation.
Assessment of Safety and Effectiveness
The Office of Health Technology Assessment (GHTA) within the
National Center for Health Services Research has been asked by HCFA to
evaluate the safety and effectiveness of heart, pancreas, and liver
transplantation. PHS assessment of the heart transplant has been
suspended until the Battelle Center National Heart Transplantation Study
is completed in April and a report submitted in July. The results of the
pancreas assessment should also be available then.
513
In April, 1982 HCFA asked the PHS to reassess liver transplantation,
after the PHS had previously determined the procedure to be experimental
in 1980. QHTA, as is its usual practice, has published a notice in the
Federal Register about its intent to evaluate these technologies and, at
the same time, contacted appropriate Federal agencies, medical specialty
societies, and health insurance and manufacturing associations. With
material from these sources, information that the NIH Consensus
Development Conference on Liver Transplantation generates, and staff
review of the literature, OHTA will develop PHS recommendations regarding
the safety and effectiveness of liver transplantation for usual
circumstances in the practice of medicine for HCFA's use in making
coverage decisions. The results of the liver assessment should be
available sometime this summer, as well.
Conclusion
The various agencies of the Public Health Service are active in
trying to address many of the concerns voiced before this Subcommittee.
In describing our activities, I have outlined the role we play in
research, drug regulation, public health surveillance and
conscience-raising, and technology assessment. I assure you that all of
these efforts including those to develop knowledge and explore new
treatments will continue in the hope that ultimately research will
identify the causes and progression of these diseases, thus preventing
the need for organ transplantation.
I would be pleased to answer any questions.
514
Dr. Brandt. With your permission, Mr. Chairman, I would like
to now ask Dr. Koop to elaborate on the Conference on Organ Pro-
curement.
Mr. Gore. Dr. Koop, we welcome you to the subcommittee.
Please proceed.
STATEMENT OF C. EVERETT KOOP, M.D., SURGEON GENERAL, U.S.
PUBLIC HEALTH SERVICE
Dr. Koop. Thank you, Mr. Chairman.
As a pediatric surgeon for 35 years, I know that there are only
two possibilities when a child has true biliary atresia: liver trans-
plantation— not available until recently — or death.
I certainly am moved by the plight of families and their children
as they await livers for transplantation. The President and Mrs.
Reagan have shown their personal concern for such children and
have asked me to help where I could.
However, the problem is broader than just liver transplantation.
And it is important not merely to help in the individual case, vital
as that may be, but to achieve an increase in the overall supply of
organs, for the shortage of organs in future years will be such that
pleas will be sounded many times in behalf of adults as well as
children as transplantation expertise expands to include other
organs.
I am therefore convening a group of experts in Winchester, Vir-
ginia, June 7 to 9 this year, to discuss methods of increasing the
supply of organs donated for transplantation. The workshop is in-
tended to stimulate members of the private sector so that they will
be more effective in focusing their efforts in this area.
The participants will discuss donation of solid organs, of hearts
or heart-lung combinations, kidneys, and livers. The state of the
art demands that for heart and liver to be considered for trans-
plantation, the prospective donors must be on respirators at the
time of death.
In addition, of course, a kidney may be used from a living donor,
but most are now taken from cadavers. We hope that any suggest-
ed measures will increase the supply of all transplantable organs.
About 40 people will meet at this conference. They will represent
a cross section of experts in transplant surgery, brain surgery and
brain death, tissue typing, and emergency medicine. Others will in-
clude representatives from voluntary associations which promote
research and transplantation.
Others will be those who have encouraged relatives to donate
organs at the time of deaths in families. Still others will include
the family of a child who in death donated organs and the parents
of children who needed liver transplants.
Finally, we shall have a group of catalysts, including, for exam-
ple, an expert on the role of the media, a sociologist, an ethicist,
and others.
The aim of the workshop therefore will be to bring together ap-
propriate representatives of public and private sectors to find edu-
cational means for the following:
515
First, to encourage the general public — in particular, relatives of
dying people on respirators — to think about the good that might be
accomplished through the timely donation of organs.
Second, to encourage the active but compassionate participation
of physicians, nurses, and other members of the medical team in
the organ procurement process.
Now, sir, the workshop is grounded on some general assump-
tions. First, it is wise to retain our present voluntary system of
organ procurement. We should consider carefully the many disad-
vantages of trying to require that people contribute organs.
Parenthetically, I might say that one disadvantage is that Ameri-
cans probably would not readily accept such a duty when, in con-
trast, they would be quite willing to donate. Indeed, one of the fea-
tures that must have appealed to State legislators a dozen or so
years ago when they accepted the Uniform Anatomical Gift Act
was that it contained the word "gift."
Another assumption is related to the first. It is that the govern-
ment should not try to dictate roles for an effort in which private
sector organizations have worked so earnestly. For years, people in
the private sector have educated the public on the usefulness of
organ donations. Their representatives have approached relatives
when deaths occurred to suggest a method whereby a life that was
ending would help others.
The conferees will learn about techniques that have been effec-
tive in encouraging families and physicians to consider the useful-
ness of transplantation when a person is on a respirator and is
either brain-dead or dying. I trust therefore that I, as well as
others, will learn much at this conference.
Having lost a child of my own, I know that parents of dying
youngsters seek to find any positive aspect in their loss. One such
aspect could be that from the death of one child, four people lived
and two received new sight. In the future, this could be more than
four as the world of organ transplant evolves.
If we can convince many families to think in these terms, we will
have achieved our goal.
Thank you.
[The prepared statement of Dr. Koop follows:]
516
TESTIMONY ON
SURGEON GENERAL'S WORKSHOP
ON SOLID ORGAN PROCUREMENT FOR TRANSPLANTATION:
EDUCATING THE PHYSICIAN AND THE PUBLIC
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U. S. HOUSE OF REPRESENTATIVES
APRIL 27, 1983
C. EVERETT KOOP, M.D.
SURGEON GENERAL
UNITED STATES PUBLIC HEALTH SERVICE
517
Mr. Chairman and Members of the Subcommittee:
As a pediatric surgeon for thirty-five years, I know that there
are only two possibilities when a child has biliary
atresia — liver transplantation (not available until recently)
or death. I am moved by the plight of families and their
children as they await livers for" transplantation. The
President and Mrs. Reagan have shown their concern for such
children and have asked me to help where I could.
However, the problem is broader than just liver
transplantation. And it is important not merely to help in
individual cases — vital as that may be — but to achieve an
increase in the overall supply of organs. For the shortage of
organs in future years will be such that pleas will be sounded
many times, in behalf of adults as well as children, as
transplantation expertise expands to include other organs.
I am therefore convening a group of experts in Winchester,
Virginia, June 7 to 9, 1983, to discuss methods for increasing
the supply of organs donated for transplantation. The workshop
is intended to stimulate members of the private sector so that
they will more effectively focus their efforts in this area.
518
The participants will discuss donations of solid organs — of
hearts (or heart-lung combinations), kidneys, and livers. The
state of the art demands that for those organs to be considered
for transplantation, the prospective donors must be on
respirators at the time death is declared. (In addition, of
course, a kidney- may be used from a living donor, but most are
taken from cadavers.) We hope that any suggested measures will
increase the supply of all transplantable organs.
About forty people will meet. They will represent a cross
section of experts in transplant surgery, brain surgery and
brain death, tissue typing, and emergency medicine. Others
will include representatives of voluntary associations, which
promote research and transplantation. Others will be those who
have encouraged relatives to donate organs at the time of
deaths in families. Still others will include the family of a
child who in death donated organs and the parents of children
who needed liver transplants. Finally, we shall have a group
of catalysts, including, for example, an expert on the role of
the media, a sociologist, an ethicist, and others.
519
The aim of the workshop therefore will be to bring together
appropriate representatives of the public and private sector to
find educational means for the following:
1. To encourage the general public (in particular, relatives of
people on respirators) to think about the good that might be
accomplished through the timely donation of organs.
2. To encourage the active but compassionate participation of
physicians, nurses, and other medical team members in the organ
procurement process.
The workshop is grounded in some general assumptions. First,
it is wise to retain our present voluntary system of organ
procurement. We should consider carefully the many
disadvantages of trying to require that people contribute
organs. Parenthetically, I might say that one disadvantage is
that Americans probably would not accept such a duty when, in
contrast, they would be quite willing to donate. Indeed, one
of the features that must have appealed to state legislators a
dozen or so years ago when they accepted the Uniform Anatomical
Gift Act was that it contained the word gift.
Another assumption is related to the first. It is that the
government should not try to dictate roles for an effort. in
which private-sector organizations have worked so earnestly.
520
For years, people in the private sector have educated the
public on the usefulness of organ donations. Their
representatives have approached relatives when deaths occurred
to suggest a method whereby a life that was ending would help
others.
i
The conferees therefore will learn about techniques that have
been effective in encouraging families and physicians to
consider the usefulness of transplantation when a person is on
a respirator and is either brain-dead or dying. I trust that I
as well as others will learn much.
Having lost a child of my own, I know that parents of dying
youngsters seek to find any positive aspect of their loss. One
such aspect could be that from the death of one child, three
people lived and two received renewed sight. If we can
convince many families to think in those terms, we will have
achieved our goal.
521
Mr. Gore. Thank you very much. We are going to hold our ques-
tions, of course, until the panel has concluded.
Carolyne Davis is Administrator of the Health Care Financing
Administration with HHS. Dr. Davis, we are delighted to have you
here. Please proceed.
STATEMENT OF CAROLYNE K. DAVIS, PH. D., ADMINISTRATOR,
HEALTH CARE FINANCING ADMINISTRATION; ACCOMPANIED
BY DR. DONALD YOUNG
Dr. Davis. Thank you very much, Mr. Chairman.
I, too, am pleased to be here. I want to discuss the systems that
we have in place for making organs available for transplantation. I
will concentrate predominantly on the medicare ESRD program
that is administered by HCFA.
As you know, in 1972, legislation provided medicare coverage to
virtually all individuals with ESRD. Chart 1 will show you the
enormous growth in the program.
[The chart follows:]
522
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In 1974, there were 18,400 beneficiaries, and the total cost of the
program at that point in time was $229 million.
Today our medicare program protects approximately 93 percent
of all of the people who are receiving end-stage renal disease serv-
ices. The cost in 1982 for 72,800 individuals was about $2 billion.
This represents approximately 4 percent of the total program ex-
penditures of medicare and roughly 9 percent of the part B expend-
itures in medicare.
These expenditures go for one-quarter of 1 percent of our medi-
care beneficiaries. As you can see, they have grown much faster
than they were initially projected when the original law was
passed.
Transplantation, as you know, is one of three types of treatment
for ESRD, together with hemodialysis and peritoneal dialysis. In
terms of transplantation, there have been approximately 38,650
kidney transplants performed between 1982 and the beginning of
the Medicare ESRD program in 1973. We now have roughly 15,700
individuals who are currently still alive and living with a function-
ing transplanted kidney.
Chart 2 does indicate that in 1982 there was a total of 5,358
kidney transplants. There has been a slight yearly increase, but it
is not, I think, as significant an increase as what we would like to
see in terms of the overall transplantation efforts of kidneys.
[The chart follows:]
524
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525
Cost effectiveness of the kidney transplant program in relation-
ship to the annual dialysis cost is also an important consideration.
Recent studies have indicated that the average annual medicare
program cost per patient for dialysis, including the physician's fees,
is approximately $18,000 a year.
The average medicare program cost for a transplant patient, in-
cluding all of the services for the first year, is approximately
$37,000. Post-transplant annual drug costs are running approxi-
mately $2,000.
Now, there are significant differences between the medicare and
the medicaid eligibility for all types of transplant recipients. The
medicare entitlement is for currently or fully insured individuals
who have end-stage renal disease, as well as for the individual
spouse or dependent child who contracts the end-stage renal dis-
ease.
In contrast, there are no eligibility requirements within the med-
icaid program that are specific in the area of organ donor trans-
plant. The State has a choice to cover any type of organ transplant
service, although generally they do await some guidance as to what
is termed experimental. But they have reponsibility of making de-
cisions on individual circumstances. They do require that the indi-
vidual persons must meet the income and the resource require-
ments that are standards of the medicaid program in that specific
State.
Medicare coverage and reimbursement for the kidney transplant
program includes both part A and part B. Part A is the hospital
insurance part, that covers the costs of the in-patient hospital serv-
ices for both the kidney donor and the recipient of the kidney. Part
B, of course, covers the surgeon's fee.
We also cover payments to the individuals who perform the ca-
daver donor excisions, and we pay those at 100 percent of the rea-
sonable costs under part A.
In terms of kidney procurement, the organ procurement agen-
cies, as you know, perform or coordinate the collection of donated
organs and their preservation and transportation, and then they
maintain a system to locate the prospective recipients for the har-
vested organs.
I thought you would find chart 3 of interest. It is a chart which
indicates the number of the organ procurement programs and their
locations. There are 36 independent organ procurement agencies
which are designated on the chart by squares. Those independent
organ procurement agencies are located in some 22 States and the
District of Columbia. These are the ones that participate in our
medicare program.
There are approximately 140 hospitals that have their own organ
procurement programs, too. These facilities appear as triangles on
the map.
I think if you look at chart 4, this clearly indicates that there are
157 certified kidney transplant centers which meet our medicare
utilization requirements. The location, as you can see, is somewhat
similar to the organ procurement program agencies.
[The charts follow:]
23-029 0-83-34
526
Ki
)
3
35
527
528
I would like to point out that of the 157 kidney transplant cen-
ters, there are a number of centers in the area that only do under
20 a year, and the number that do under 20 a year is roughly 50
percent. They are the ones that are shown on the chart as white
circles.
Likewise, the triangle figures are the transplant centers that
transplant between 21 and 50 kidneys a year.
The squares represent those facilities that are transplanting be-
tween 51 and 100.
And then the star figures represent centers, of which you will
find eight in the country or roughly 5 percent of the total, that are
transplanting 100 or more kidneys.
We have one intermediary that does service all of our independ-
ent procurement agencies and all of our independent histocompati-
bility laboratories. The hospitals that have organ procurement pro-
grams are reimbursed by their own intermediaries through their
kidney acquisition cost center, and that is based upon reasonable
cost.
The patients meet a variety of criteria determined by the medi-
cal community in order to be candidates for a transplant, and of
course that includes the stable medical component in order to with-
stand the procedure. They should have no secondary types of diag-
noses and should be between 10 and 55 years of age, although those
criteria do change occasionally according to the medical specifica-
tions.
Generally speaking, we find that the same candidates for trans-
plants are also the same candidates for home dialysis programs.
As I mentioned earlier, we did have 72,800 medicare end-stage
renal disease patients in 1982, and of those we had approximately
4,900 who did have kidney transplants. Of those, I think it was sig-
nificant that 3,681 received a cadaveric kidney, and 1,667 received
a living donor kidney.
We do know from recent work that has been done by our re-
search staff that a group of transplant patients would cost the
medicare program less than a group of dialysis patients after a 4-
year period of time when one considers the aggregate costs for the
4-year period for the respective groups.
The survival rates, as you know, have improved dramatically in
the last 2 or 3 years. The rehabilitation and the improved quality
of life and the work potential have been shown to be the highest
for a kidney transplant patient, according to our recent study by
Battelle.
We have several studies in the area of transplantation that I
would like to mention very briefly. They are covered in detail in
my testimony.
We have embarked upon a 5-year plan for research and demon-
stration in the ESRD area. There are two specific studies I have
already mentioned. The Battelle Institute study that we granted in
1981 is looking at the quality of life, the quality of care, and the
cost of patients who undergo different types of therapy. It has ana-
lyzed 11 renal dialysis centers and facilities and about 900 patients
and has concluded that kidney transplant patients and patients
who are on home dialysis are more likely to be working and have a
lower level of functional impairment.
529
A second and important study, also, that was begun in 1981
through the Brandeis Health Policy Consortium is looking at meth-
ods to increase the public participation in the kidney donation pro-
gram. This study is addressing methodologies and structures in the
area of organ procurement, trying to study the operational efficien-
cy of the independent organ procurement agencies, and to deter-
mine what are the most effective ways to obtain and to distribute
kidneys.
We hope that we can correlate and analyze the state of the art in
the organ procurement area and develop a model for a successful
kidney procurement agency and evaluate the differences — and why
the differences are there— between the various independent organ
procurement agencies.
In terms of coverage, the law states that the medicare programs
can only pay for those services that are reasonable and necessary.
Therefore, medicare does not pay for devices, procedures,or tech-
niques that are still considered investigational.
Chart No. 5 indicates to you how our decisions are made with re-
lationship to medicare coverage. When a coverage issue, such as
the possibility of coverage of an organ transplant, is brought to our
attention, either by our regional office staff or our fiscal interme-
diaries, the Office of Coverage Policy conducts a search of the medi-
cal literature and looks at any other relevant background material
that is available.
[The chart follows:]
530
CHbfLT 5
How Decisions Are Made
Regarding Medicare Coverage
HCFA Receive*
Question
HCFA Searches
Medical Literature.
Background
Questions Referred
to HCFA
Physician Panel
Panel Resolve*
Question
Panel Make*
Informal Inquiry
toPHS
PHS Conducts
Review. Discussions
with PHS Agendas
PHS Provides
Background
Information
HCFA Datermlnas
Coverage Policy
Panel Requests Full
PHS Assessment on
Safety & Efficacy
PHS Solicltes Information
from Medical Specialty
Groups. PHS Agencies b
the Public & Reviews
Literature
PHS Provides Formal
Recommendation
4/19/83
531
If it appears that the device or the procedure may be investiga-
tional, then our HCFA physicians panel reviews the issue. Dr.
Donald Young, who is with me today, chairs that panel. Our physi-
cians panel may resolve the question, or they may refer it to the
Public Health Service either for an informal inquiry or a request
for a full assessment relative to safety and efficacy.
An informal request will usually involve a more intensive review
of the medical literature, a discussion with other individuals in the
government, and a response to specific questions that may have
been raised by our physicians panel.
The full assessment would involve consultation by the Public
Health Service with affected medical specialty groups and other
professional organizations in ascertaining the consensus within the
medical community relative to the safety and efficacy of the service
or procedure.
When the Public Health Service has completed their evaluation,
they make a formal recommendation to HCFA relative to the
safety and efficacy of the device or procedure. HCFA then deter-
mines whether the device or the procedure should be covered by
medicare.
At the present time, as you know, the medicare program's cover-
age for organ transplants is limited to kidney and cornea trans-
plants. However, I stressed earlier, and would stress again, that
under medicaid, we would match the State's funding for any organ
transplant that they choose to cover.
We also are doing a study relative to heart transplants in terms
of evaluating all of the aspects of the heart transplantation under
medicare. Chart 4 shows that we have 10 heart transplant cen-
ters—designated by the black circles— that are doing heart trans-
plantations under the medicare program.
The study is trying to determine the need for heart transplants,
survival of the heart transplant recipients, potential availability of
donor hearts, costs, rehabilitation, quality of life of heart trans-
plant recipients, and the legal and ethical aspects of heart trans-
plantion.
As part of this study, we are reimbursing a limited number of
heart transplants— 16 in number. We have already paid for nine
transplants that have been performed under this study. The study
is scheduled to be completed in April 1984, with the evaluation to
be finished 3 months later. Once this particular study is completed,
we will be consulting further with the Public Health Service for a
decision relative to coverage of heart transplantion under the medi-
care program.
In terms of liver transplantation, the black diamond-shape fig-
ures on Chart 4 indicate the centers that we know are doing liver
transplants. They tend to coincide very closely with the other areas
where major transplant centers are.
At the end of 1980, the Public Health Service responded to a
HCFA request for guidance on liver transplants and stated at that
time that they were still investigational. Since that time, cyclo-
sporin A, although it is still experimental, has been used more
widely and there seems to be some evidence that it has a favorable
effect on liver transplantion.
532
Therefore, in April 1982, we referred the questions again of
safety and efficacy of liver transplants to the Public Health Service
for a reassessment. We asked them to consider the questions of cov-
erage in relationship to specific subgroups of the population. We
did this specifically because there is some indication that there is a
different success rate in liver transplants between children and
adults and that the recent breakthroughs may have indeed affected
the survival rates more favorably in terms of children.
In terms of pancreatic transplants, we asked the Public Health
Service for its recommendations relative to the safety and efficacy
of pancreatic transplants, especially those with respect to the end-
stage renal disease beneficiary who is a diabetic and who may have
undergone a kidney transplant or may wish to undergo a kidney
transplant.
In conclusion, Mr. Chairman, as a nurse and as a former health
care provider, I have watched with great interest and some degree
of excitement the technological advances that have allowed us to
prolong life, to prevent and to retard morbidity, and to enhance the
quality of life.
But, as the Administrator of HCFA, I have an additional respon-
sibility as the guardian of the trust funds supporting the medicare
program to assure that we are reimbursing for the care which is
reasonable and necessary as is required by law.
As you know, the trust funds have been recognized as being in
some degree of jeopardy in future years. Our actuaries project that
the hospital insurance trust fund could be insolvent in 1990, and
that we will have to slow the rate of growth of program expendi-
tures by approximately 33 percent or double our payroll taxes in
the next decade if we are to assure that that program will
continue.
We, of course, must assure ourselves that we are providing the
ability to pay for the health care for those aged and disabled who
are entitled to the medicare program. Therefore, the health incen-
tives reform proposals we submitted in our 1984 budget are an-
other step toward slowing the growth. We also need to carefully
assess all new technologies and weigh their benefits and costs care-
fully.
I do not pretend that there are any easy answers to the critical
problems, but I think I would be remiss if I did not raise these par-
ticular issues.
I do feel strongly that the trust moneys should be spent only on
procedures and care that is generally accepted by the medical com-
munity as safe and efficacious, and, indeed, the law requires that
medicare pay only for the services which are reasonable and neces-
sary.
I do think that is particularly important in these days of escalat-
ing health care costs. We are carefully considering, in close consul-
tation with our medical experts in the Public Health Service, all
decisions on safety and efficacy of all transplant procedures before
we permit further coverage under the medicare program.
I look forward to working with both the Public Health Service
and Congress as we continue to look at these important issues, and
I thank you for raising the issues.
[The prepared statement of Dr. Davis follows:]
533
STATEMENT OF
CAROLYNE K. DAVIS, PH. D.
ADMINISTRATOR
HEALTH CARE FINANCING ADMINISTRATION
INTRODUCTION
Mr. Chairman, I am Carolyne K. Davis, the Administrator
of the Health Care Financing Administration (HCFA).
I AM PLEASED TO BE HERE TO DISCUSS THE SYSTEMS WHICH ARE
IN PLACE FOR MAKING ORGANS AVAILABLE FOR TRANSPLANTATION.
I WILL CONCENTRATE MY COMMENTS TODAY ON THE MEDICARE END-
Stage Renal Disease (ESRD) program, which is mandated under
Public Law 92-603 (the Social Security Amendments of 1972)
and Public Law 95-292 (which was enacted in 1978) and administered
by HCFA.
ESRD RESPONSIBILITIES
In 1972, Congress gave the Federal Government a unique
role by providing medicare protection to virtually all
persons with ESRD. Currently, Medicare protects approximately
93 percent of people receiving any ESRD services.
Medicare costs for ESRD patients were about $2 billion
in 1982. This was about four percent of total program
expenditures and represents about nine percent of Part
B expenditures. These expenditures were for one quarter
of one percent of Medicare beneficiaries, and they have
grown much faster than were originally projected when the
law was passed.
534
In July 1973, at the beginning of the Medicare ESRD program,
THERE WERE APPROXIMATELY 15,000 ESRD PATIENTS, OF WHOM
1,500 RECEIVED TRANSPLANTS. In 1978, PUBLIC LAW 95-292
WAS ENACTED TO ENCOURAGE EFFICIENCY AND ECONOMY IN THE
ESRD PROGRAM, IN PARTICULAR, THE LEGISLATION ENCOURAGED
SELF-DIALYSIS AND TRANSPLANTATION TO REDUCE LONG-TERM PROGRAM
COSTS.
TO UNDERSTAND THE TREATMENT OF ESRD, 1 WOULD LIKE TO BRIEFLY
DESCRIBE THE NATURE OF ESRD. As YOU KNOW, THE FUNCTION
OF HUMAN KIDNEYS IS TO COLLECT AND DISPOSE OF BODY WASTES
FORMED IN THE BLOOD DURING METABOLISM. ESRD IS A PERMANENT
AND IRREVERSIBLE BREAKDOWN OF THE CAPACITY OF THE KIDNEYS
TO CARRY^T THIS DISPOSAL FUNCTION. ESRD REQUIRES ARTIFICIAL
REMOVAL OFTHESE WASTES THROUGH DIALYSIS OP REPLACEMENT
OF THE KIDNEY THROUGH TRANSPLANTATION. FAILURE TO PROVIDE
TREATMENT RESULTS IN DEATH. :
There are two types of dialysis treatment: hemodialysis
and peritoneal dialysis. at the end of 1982, 82 percent
of esrd patients were treated in a dialysis facility and
18 percent of esrd patients were on home dialysis.
Hemodialysis, the more widely used dialysis modality, filters
blood through an artificial kidney machine to remove wastes
before the blood is returned to the body. hemodialysis
may be performed in a dialysis facility, which may be a
T
\
\
535
HOSPITAL OR A FREESTANDING FACILITY, OR IN THE HOME AT
A LESSER COST. AT THE END OF 1982, 83 PERCENT OF HEMODIALYSIS
esrd patients were treated in a dialysis facility and 17
percent of esrd patients were on home dialysis.
in peritoneal dialysis, the filtering takes place within
the patient's abdominal cavity without the blood leaving
the body. Peritoneal dialysis may be performed in a dialysis
facility, which may be a hospital or a freestanding facility,
in the home, or on an ambulatory basis. at the end of
1982 more than 56 percent of home dialysis patients were
treated by continuous ambulatory peritoneal dialysis.
In 1981. the Congress directed HCFA to encourage home dialysis
THROUGH INCENTIVES IN A REVISED RATE STRUCTURE. In DOING
this, the Congress recognized that home dialysis offers
great potential for the improvement of the quality of life
FOR THOSE ESRD PATIENTS WHOSE DOCTORS BELIEVE THEY ARE
ELIGIBLE FOR THIS MODALITY.
Transplantation is the other major treatment for ESRD and
IS MORE DIRECTLY THE SUBJECT OF THE HEARING TODAY. TRANSPLANT-
ATION IS THE SURGICAL PROCEDURE WHICH INVOLVES IMPLANTING
KIDNEYS FROM LIVING DONORS OR CADAVERS INTO ESRD PATIENTS.
IN 1982, APPROXIMATELY 31 PERCENT OF THE 5,358 TRANSPLANTS
PERFORMED INVOLVED LIVING RELATED DONORS. TRANSPLANTS
FROM LIVING RELATED DONORS ARE PREFERRED BY TRANSPLANT
536
surgeons and have yielded a lower rejection rate. this
could change with improvements in immunosuppressant drugs.
Between 1973 and 1982, there have been approximately 38,650
TRANSPLANTS PERFORMED. As OF THE END OF 1982, THERE WERE
APPROXIMATELY 16,000 PEOPLE WITH FUNCTIONING GRAFTS. As
of December 31, 1982, there were 65.763 dialysis patients
AND ABOUT 6,700 OF THESE PATIENTS WERE ON A TRANSPLANT
WAITING list. It IS difficult TO ASSESS the actual percentage
of this population who would be eligible for transplantation
at any given point in time due to a variety of factors
such as willingness of patients, co-morbid conditions,
and lack of uniform standard medical patient selection
protocols. the number of transplants performed over the
last few years has not increased proportionately with increases
in the overall esrd population. one should realize that
the esrd population is characterized by older and sicker
patients each year.
the cost-effectiveness of transplantation can be considered
in relation to annual dialysis costs. the average annual
Medicare program costs for dialysis including physicians'
fees is $18,000. The average Medicare program costs per
transplant patient including all services is approximately
$37,000 FOR THE FIRST YEAR OF TRANSPLANT. In ADDITION,
ACCORDING TO A MAJOR ESRD STUDY CURRENTLY UNDERWAY, POST-
TRANSPLANT ANNUAL DRUG COSTS ARE APPROXIMATELY $2,000.
537
MFnir.ARF/MEDICAin EL1GIB1I 1TY FOR TRANSPLANT RECIPIENTS
The Social Security Act provides Medicare entitlement for
currently or fully insured individuals with end-stage renal
Disease who require regular kidney dialysis or receive
A KIDNEY TRANSPLANT. THIS COVERAGE ALSO APPLIES TO THE
INDIVIDUAL'S SPOUSE OR DEPENDENT CHILD IF ONE OF THEM CONTRACTS
ESRD AND INITIATES DIALYSIS OR RECEIVES A TRANSPLANT.
THE FIRST DAY OF COVERAGE FOR MEDICARE VARIES DEPENDING
ON THE MODE OF TREATMENT. In GENERAL, AN INDIVIDUAL ON
DIALYSIS RECEIVES BENEFITS THREE MONTHS AFTER THE START
OF DIALYSIS, OR IF AN INDIVIDUAL ELECTS HOME DIALYSIS,
COVERAGE BEGINS ONE MONTH AFTER A COURSE OF HOME DIALYSIS
COMMENCES. An INDIVIDUAL WHO RECEIVES A KIDNEY TRANSPLANT
BEGINS COVERAGE WITH THE MONTH OF THE TRANSPLANT OR 2 MONTHS
earlier if he or she is hospitalized in preparation for
the transplant.
Coverage ends 35 months after the month of transplant unless
THE TRANSPLANT FAILS AND THE INDIVIDUAL BEGINS A COURSE
OF DIALYSIS OR RECEIVES ANOTHER TRANSPLANT.
There are no eligibility requirements in the Medicaid program
that are specific to persons who require organ transplants.
Persons who require organ transplants must meet the same
categorical and income and resource standards that all
538
other persons must meet in order to become eligible for
Medicaid. If these requirements are met, the individual
IS ELIGIBLE FOR ANY OF THE MEDICAID PROGRAM SERVICES OFFERED
BY HIS/HER PARTICULAR STATE. THE AVAILABILITY OF ORGAN
TRANSPLANTS TO A MEDIC AID-EL 1 GIBLE THEN DEPENDS ON WHETHER
A STATE HAS CHOSEN TO COVER SUCH SERVICES UNDER ITS MEDICAID
PLAN.
MEDICARE COVERAGE AND REIMBURSEMENT FOR KIDNEY TRANSPLANTATION
Both Parts A and B (Hospital Insurance and Supplemental
Medical Insurance) of Medicare help pay for kidney transplant
surgery. Part A Hospital Insurance will cover the costs
OF inpatient hospital services for both the kidney recipient
AND THE DONOR. THESE SERVICES MAY INCLUDE A PRE-EVALUAT ION,
THE KIDNEY PROCUREMENT, AND THE ACTUAL TRANSPLANT OPERATION.
Part B medical insurance will pay for a surgeon's renal
TRANSPLANTATION SERVICES ON A COMPREHENSIVE PAYMENT BASIS
FOR SERVICES RENDERED DURING A 60-DAY PERIOD. THE PAYMENT
CAN VARY DEPENDING ON WHETHER THE RENAL SURGEON PERFORMED
OTHER SURGICAL PROCEDURES AT THE TIME OF THE TRANSPLANTATION
OR WHETHER HE/SHE PROVIDED SUPERVISION OF THE IMMUNOSUPPRESSANT
therapy over a period of 60 days following surgery. this
payment is a variation of the reasonable charge method
used by the medicare program to pay for all physicians'
services. the maximum program amounts currently allowed
by Medicare carriers for renal transplantation by a surgeon,
539
including immunosuppressant therapy for 60 days, range
from $1,734 to $2,875.
Payment to surgeons who perform cadaveric donor excisions
IS MADE AT 100 PERCENT OF THE REASONABLE COST UNDER PART
a. a recent intermediary survey indicated that a median
cost of approximately $800 is paid by independent organ
Procurement Agencies for a surgeon's removal of cadaveric
kidneys. All physicians' services rendered in connection
with removal of the living donor's kidney are reimbursed
using Medicare reasonable charges. Average payments are
APPROXIMATELY $1,100 FOR THIS SERVICE.
KIDNEY PROCUREMENT
Organ procurement is performed by organ procurement agencies
(OPAs). These agencies perform or coordinate harvesting
of donated organs, preservation of donated kidneys, transport-
ation OF DONATED KIDNEYS, AND MAINTENANCE OF A SYSTEM TO
LOCATE PROSPECTIVE RECIPIENTS FOR HARVESTED ORGANS.
There are 36 independent OPAs located in 22 states and
the District of Columbia which are certified to participate
in Medicare. In addition, approximately 140 hospitals
have their own Organ Procurement Programs.
The independent OPAs usually coordinate a network of participating
540
HOSPITALS THAT HAVE AGREED TO IDENTIFY POTENTIAL KIDNEY
DONORS. OPA PERSONNEL GO TO A HOSPITAL AFTER REMOVAL OF
kidney tissue to preserve the tissue in the appropriate
apparatus. an opa transplant coordinator is responsible
for transporting donated kidneys from the donor site to
the transplant hospital for transplantation. there are
157 certified transplant centers which meet medicare utilization
requirements.
Computer matching systems have been developed to permit
effective organ sharing between geographically distinct
transplant centers. opas are responsible for locating
the best recipient match for the donated kidney.
One intermediary, Aetna Life and Casualty of Hartford,
Connecticut, services, all independent OPAs and all independent
histocompatibility (tissue typing) laboratories. Hospitals
HAVING THEIR OWN OPAS ARE REIMBURSED BY THEIR INTERMEDIARIES
THROUGH THEIR KIDNEY ACQUISITION COST CENTERS. MEDICARE
REIMBURSEMENT FOR PROCUREMENT SERVICES PROVIDED BY THESE
ENTITIES IS BASED ON REASONABLE COST.
TRANSPLANTATION PATIENT BACKGROUND
Transplantation is not a treatment that is suitable for
ALL ESRD PATIENTS. PATIENTS WHO ARE GOOD TRANSPLANT CANDIDATES
MUST MEET A VARIETY OF CRITERIA DETERMINED BY THE MEDICAL
541
community. Usually, transplant candidates must be sufficiently
stable medically to tolerate the procedure, and have no
secondary diagnosis, and be between 10 and 55 years of
age. it is important to note that the pool of patients
for transplant are usually the same people who are candidates
for home dialysis.
as i noted earlier, there were approximately 15,000 patients
at the beginning of the medicare esrd program of whom 1,500
had been transplanted. in 1982, there were more than 70,000
ESRD PATIENTS AND 5,358 TRANSPLANTS PERFORMED. Of THE
5,358 transplants performed last year, 1,667 were from
living related donors and 3,681 used cadaveric kidneys.
Post transplant services for successful patients include
periodic outpatient examinations to monitor for rejection,
to prescribe medications, and to monitor for recurrence
of kidney disease.
a group of transplant patients will cost the medicare program
less than a group of dialysis patients after four years
when considering aggregate costs across the four-year period
for the respective groups.
23-029 0-83-35
542
SURVIVAL OF TRANSPIANT PATIENTS
Survival rates of transplant patients have improved dramatically
in the last two to three years. Recent experiences at
the University of California, San Francisco, and -t the
University of Minnesota show a living related donor graft
survival rate of 95 percent in one year. This is due to
A NEW TECHNIQUE CALLED DONOR SPECIFIC TRANSFUSION WHICH
ENABLES PHYSICIANS TO PERFORM A SUCCESSFUL KIDNEY TRANSPLANT
FROM A DONOR WITH PRONOUNCED GENETIC DIFFERENCES FROM THE
RECIPIENT. IN ADDITION, THE USE OF THE EXPERIMENTAL DRUG
Cyclosporin A has reduced kidney rejection by half and
HAS REDUCED INFECTIONS IN TRANSPLANT SURGERY. (ACCORDING
TO TRANSPLANT SURGEONS AT THE UNIVERSITY OF CALIFORNIA,
San Francisco, and the University of Minnesota, their recent
TRANSPLANT EXPERIENCES SHOW THAT THEIR RESPECTIVE HOSPITAL
COSTS HAVE BEEN REDUCED BY 40 PERCENT THROUGH DECREASING
THE LENGTH OF STAY AND THE NEED FOR READMISSION BY USING
Cyclosporin A.
REHABILITATION, IMPROVED QUALITY OF LIFE, AND WORK POTENTIAL
APPEAR TO BE THE HIGHEST FOR TRANSPLANTED PATIENTS. INDIVIDUAL
STATISTICS OF MANY FACILITIES WHICH PERFORM TRANSPLANTATION
INDICATE THAT 40 PERCENT OR MORE OF THEIR SUCCESSFUL TRANSPLANT
PATIENTS RETURN TO AN EQUAL OR HIGHER LEVEL OF WORK AND
QUALITY OF LIFE THAN WHAT THEY HAD ENJOYED PRIOR TO THE
onset of ESRD. For these reasons, as well as anticipated
543
PROGRAM SAVINGS, 1 HAVE BEEN ANXIOUS TO WORK TO INCREASE
TRANSPLANTATION DURING MY TENURE AS ADMINISTRATOR, AND
I AM PARTICULARLY PLEASED THAT NEW TECHNOLOGY WILL AID
US IN WORKING TOWARD THE GOAL OF INCREASING TRANSPLANTS.
RESEARCH AND DEMONSTRATION PROJECTS IN TRANSPLANTATION
Research and Demonstration is an important agency activity
especially in esrd and transplantation because of the escalating
costs associated with the type of care needed by the esrd
patient. hcfa currently has a five-year plan for research
and Demonstration projects in the ESRD area, including
transplantation. specifically, we have two major studies
going on which i would like to describe for the subcommittee.
Through a grant to Battelle Memorial Institute in 1981,
HCFA is looking at "The Impact of Alternative Types of
Therapy on Patients with End-Stage Renal Disease." Among
other things, the study focuses on several variables, including
an examination of the quality of life, the quality of care,
and the cost of care to patients undergoing different types
of therapy for treatment of esrd. four treatment modalities
are included in the study--fac il i ty dialysis, home dialysis,
continuous ambulatory peritoneal dialysis (capd), and renal
transplantation,
This study, which is based on an analysis of 859 ESRD patients
544
FROM 11 RENAL DIALYSIS CENTERS AND FACILITIES, HAS ALREADY
PROVIDED US WITH SOME INTERIM FINDINGS WHICH ARE RELEVANT
TO OUR DISCUSSION OF TRANSPLANTATION TODAY. In PARTICULAR,
SIX MAJOR PAPERS HAVE BEEN WRITTEN TO DATE AND MORE ARE
EXPECTED AS THE STUDY ENTERS ITS LAST YEAR.
A FEW OF THE HIGHLIGHTS FROM SOME OF THE PAPERS ARE AS
FOLLOWS: 1
o Patients with kidney transplantation and patients
ON HOME HEMODIALYSIS ARE MORE LIKELY TO BE WORKING
AND HAVE A LOWER LEVEL OF FUNCTIONAL IMPAIRMENT.
o Results suggest that after patient case-mix has
BEEN CONTROLLED TREATMENT MODALITIES MAY BE RANKED
ACCORDING TO THE QUALITY OF LIFE ASSOCIATED WITH
them. Kidney transplant patients consistently
REPORT A HIGHER QUALITY OF LIFE THAN PATIENTS ON
OTHER TREATMENT MODALITIES ALTHOUGH IN MANY RESPECTS
HOME HEMODIALYSIS PATIENTS ARE SIMILAR.
0 ON ALL QUALITY OF LIFE INDICATORS, KIDNEY TRANSPLANT
PATIENTS WERE FOUND TO DO BETTER THAN EITHER CAPD
OR IN-CENTER HEMODIALYSIS PATIENTS.
o Comparisons between ESRD transplant patients and
THE GENERAL POPULATION ACROSS THE SUBJECTIVE INDICATORS
545
OF THE QUALITY OF LIFE DID NOT REVEAL ANY SIGNIFICANT
DIFFERENCES.
o Kidney transplant patients experience the least
FUNCTIONAL IMPAIRMENT, FOLLOWED BY HOME HEMODIALYSIS
PATIENTS, PATIENTS WHO HAD A FAILED KIDNEY TRANSPLANT,
IN-CENTER HEMODIALYSIS PATIENTS AND LASTLY CAPD
PATIENTS.
o Work disability among patients varied by treatment
MODALITY WITH TRANSPLANT PATIENTS MOST LIKELY TO
BE WORKING.
o Kidney transplant patients, both those with failed
AND THOSE WITH FUNCTIONING GRAFTS, USED MORE REHABILITATION
SERVICES THAN THE OTHER PATIENT GROUPS.
o When the data are not adjusted for case-mix differences
(age, sex, race, education, wealth, and health),
significant differences in labor force participation
are observed in all four treatment modalities.
in particular, kidney transplant patients are
more likely to be working followed by patients
on home hemodialysis, in-center hemodialysis,
AND CAPD.
546
However, once patient case-mix differences
are controlled, several of the differences
are reduced. only kidney transplant patients
have a clearly greater participation in the
work force after case-mix differences are controlled.
In the fall of 1981, the University Health Policy Consortium
began a multi-year study into "methods for increasing public
Participation in Kidney Donation Programs." The study
addresses the methodologies and structure of organ procurement,
the first phase of this hcfa-sponsored grant was to study
the operational efficiency of the independent organ procurement
Agencies and to measure their effectiveness in obtaining
and distributing kidneys.
One of the goals of this study is to correlate and analyze
the state of the art in organ procurement in order to develop
a model of a successful kidney procurement agency. a second
goal is to describe and evaluate differences among independent
Organ Procurement Agencies.
While there are some areas of agreement among Independent
Organ Procurement Agencies, there are certainly many areas
of disagreement and controversy. for example, under the
study we learned that public education is the most controversial
aspect of organ procurement. the study has indicated that
some Independent Organ Procurement Agencies believe that
547
public education is ineffective and should not be part
of organ procurement efforts. other independent organ
Procurement Agencies consider public education to be successful
and think that the public attitude influences the willingness
of medical professionals to assist in procurement efforts.
Through our grant solicitation process, we are currently
looking for proposed approaches to analyze differences
in outcomes and related factors in kidney transplants and
development and testing of systems that include incentives
TO PROMOTE AVAILABILITY OF KIDNEYS. In ADDITION TO THESE
topics, we published other topics for study in esrd in
the April 6th edition of the Federal Register. Renal studies
will be reviewed as part of our next grants application
cycle. we hope that future research on esrd issues will
provide the needed data to revise and reshape our policies
affecting this severely ill population.
COVERAGE DECISIONS AND ACTIVITIES
The law states that Medicare should pay only for those
services which are reasonable and necessary. therefore,
Medicare does not pay for devices, procedures, or techniques
that are considered to be investigational. when a coverage
issue such as an organ transplant is brought to hcfa's
attention— by, for example, one of our fiscal contractors
or a regional office - the office of coverage policy conducts
548
a search of the medical literature and also reviews any
other background material that has been submitted regarding
the issue. if it appears from these reviews that the device
or procedure may be in an investigational state of development,
the issue is referred to the hcfa physicians panel for
review. That Panel either resolves the question or refers
it to the Public Health Service (PHS) on either an informal
inquiry basis or with a request for a full assessment as
to safety and efficacy. Informal requests usually involve
a more intensive review of the medical literature, discussions
with other government components, and clarification of,
and response to, specific questions raised by the Panel.
A full assessment as to safety and efficacy involves the
consultation with affected medical specialty groups and
other professional organizations and the gathering of information
as to the consensus within the medical community regarding
the safety and efficacy of the service or procedure. when
phs has completed the information-gathering and evaluation
process, it makes a formal recommendation to hcfa with
respect to the safety and efficacy of the device or procedure,
and hcfa then decides whether the device or procedure should
be covered by medicare.
At present, the Medicare program's coverage of organ transplants
is limited to kidney and cornea transplants. Under the
549
Medicaid program, we presently match the states' funds
for any organ transplant they choose to cover,
The question of Medicare coverage has arisen with respect
to coverage of heart transplants, liver transplants, and
pancreas transplants. i would like now to describe briefly
our consideration of each of these types of transplants.
HEART TRANSPLANTS
a national study, financed by hcfa, is now underway of
all aspects of coverage of heart transplantation under
Medicare. This includes:
1) the estimations of the potential need for heart
transplants;
2) the survival of heart transplant recipients;
3) the potential availability of donor hearts;
4) the cost of performing heart transplants;
5) the rehabilitation and quality of life of heart
transplant recipients; and
6) the legal and ethical aspects of heart transplantations.
550
The project staff includes an inter-disciplinary team of
researchers with expertise in such areas as medical sociology,
cardiovascular medicine, transplant surgery, health economics,
cardiology, political science, law. medical ethics, geography,
and psychology. as part of that study, medicare is paying
for a limited number of heart transplants at six medical
centers participating in the study. at present, plans
CALL FOR LIMITING PAYMENT TO 16 TRANSPLANTS. At THIS TIME
HCFA HAS PAID FOR NINE HEART TRANSPLANTS PERFORMED UNDER
THIS STUDY.
The study is scheduled to be completed in April 1981, and
the evaluation is to be finished three months later. when
the entire study process is completed, hcfa will make a
decision regarding coverage of heart transplantation under
Medicare.
LIVER TRANSPLANTS
At the end of 1980, PHS responded to a HCFA request for
GUIDANCE ON LIVER TRANSPLANTS. THE PHS DETERMINATION WAS
THAT LIVER TRANSPLANTS WERE STILL INVESTIGATIONAL. SlNCE
then, Cyclosporin A, an immunosuppressant drug, has been
MORE WIDELY USED, AND THERE, IS SOME EVIDENCE THAT IT HAS
HAD A FAVORABLE EFFECT ON LIVER TRANSPLANTATION, THEREFORE,
in April 1982, HCFA referred the questions of safety and
EFFICACY OF LIVER TRANSPLANTS TO PHS FOR REASSESSMENT.
551
HCFA ASKED PHS TO CONSIDER THE QUESTIONS OF MEDICARE COVERAGE
IN TERMS OF SPECIFIC SUBGROUPS OF POPULATION. THIS WAS
DONE BECAUSE THERE ARE SOME INDICATIONS THAT THERE ARE
DIFFERING SUCCESS RATES IN LIVER TRANSPLANTS PERFORMED
ON CHILDREN AND ADULTS, AND THAT RECENT "BREAKTHROUGHS"
HAVE FAVORABLY AFFECTED ONLY THE SURVIVAL RATES OF CHILDREN.
PANCREAS TRANSPLANTS
On October 26, 1981, HCFA asked PHS for its recommendations
AS TO THE SAFETY AND EFFICACY OF PANCREAS TRANSPLANTS,
ESPECIALLY WITH RESPECT TO ESRD BENEFICIARIES WHO ARE DIABETIC
AND WHO HAVE UNDERGONE KIDNEY TRANSPLANTS.
CONCLUSION
AS A NURSE AND FORMER HEALTH CARE PROVIDER, 1 WATCH WITH INTEREST
AND EXCITEMENT THE TECHNOLOGICAL ADVANCES WHICH ALLOW US TO PROLONG
LIFE, PREVENT OR RETARD MORBIDITY, AND PROVIDE ENHANCED QUALITY
of life. As Administrator of HCFA, I have these same concerns
in mind, but i have an additional responsibility as guardian of the
Trust Funds supporting the Medicare program to assure that we
reimburse for care which is reasonable and necessary as required
by the law. , '
552
Those trust funds are in jeopardy in future years. Our
actuaries project that the hospital insurance trust fund
could be insolvent as early as 1990. we will have to slow
the rate of program expenditures or increase taxes dramatically
in the next decade if we are to assure that a program continues
to be available to pay for health care for the aged and
disabled. The Administration's health incentive reform
proposals submitted with our fy 84 budget are an important
step in this direction. we must also carefully assess
new technology and weigh its benefits and costs carefully,
i have no easy answers to these critical problems, but
i believe i would be remiss in my responsibilities if i
fail to mention them today.
i feel very strongly that trust fund monies should only
be spent on procedures and care generally accepted by the
medical community as safe and efficacious. indeed, the
law directs that medicare pay only for those services which
are reasonable and necessary, and this is critically important
in these days of escalating health care costs and possible
INSOLVENCY OF THE TRUST FUNDS. We ARE THEREFORE CAREFULLY
considering, in close consultation with our medical experts
in the Public Health Service, decisions on the safety and
efficacy of all transplant procedures before permitting
coverage and expenditure of medicare trust funds.
i look forward to working with you and others in the congress
as we look carefully at these important problems, and i
would be pleased to answer any questions you may have at
this time.
553
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558
How Decisions Are Made
Regarding Medicare Coverage
HCFA Receive!
Question
HCFA Seerches
Medical Literature.
Background
Question! Referred
to HCFA
Physician Panel
4
Panel Resolves
Question
-~~
4
Panel Makes
Informal Inquiry
^ toPHS
4
Panel Requests Full
PHS Assessment on
Safety & Efficacy
I
I ,
•
6
PHS Conduct*
Review. Discussions
with PHS Agencies
5
PHS Solicltes Information
from Medical Specialty
Groups. PHS Agencies 6
the Public b Reviews
Literature
,
1
I
PHS Provide*
Beckground
Information
•
PHS Provides Form*!
Recommendation
>
7
HCFA Determine*
Coversg
a Policy
4/19/83
559
Mr. Gore. Thank you, Dr. Davis.
Dr. Beary is our last witness on this panel, Acting Assistant Sec-
retary of Defense for Health Affairs at DOD. Welcome.
STATEMENT OF JOHN F. BEARY III, M.D., ACTING ASSISTANT SEC-
RETARY OF DEFENSE, HEALTH AFFAIRS, ACCOMPANIED BY
ALEXANDER RODRIQUEZ, M.D., MEDICAL DIRECTOR, O-CHAM-
PUS; AND ROBERT L. GILLIAT, ESQ., ASSISTANT GENERAL
COUNSEL, MANPOWER AND HEALTH AFFAIRS, DEPARTMENT
OF DEFENSE
Dr. Beary. Thank you.
Mr. Chairman and committee members, thank you for the oppor-
tunity to comment on DOD's policy on organ transplants.
The Defense Department operates 161 hospitals worldwide to
serve some 10 million military personnel, retirees, and families.
When military families cannot get their medical care in the Serv-
ices' treatment facilities, the civilian health and medical program
of the uniformed services, or CHAMPUS, shares the costs of care
from civilian providers. So we are involved with organ transplanta-
tion both as a direct provider of care and as the operator of a
health benefit plan.
Adriane Broderick, one of the children here last week, is await-
ing a liver transplant. Because her father is a career member of
the Armed Forces, we in the Defense Department are particularly
concerned. As the father of two young children myself, I can well
understand the anguish of her parents and grandparents.
Our Office of General Counsel has reviewed the legal situation
pertaining to the case and has advised me that it is legally objec-
tionable to pay for experimental medicines and surgery, until such
time that medical researchers prove that a therapy is effective and
that it is not more likely to harm the patient than to help.
Given the above restrictions, the issues before us are: No. 1, how
does CHAMPUS determine policy on whether a therapy is experi-
mental or standard?
No. 2, is liver transplantation itself experimental or standard
therapy?
No. 3, what can we do to help Adriane Broderick.
Issue No. 1 deals with technology assessment for CHAMPUS. We
accept the findings of three bodies. One is the Blue Cross Medical
Policy Council, and that is because CHAMPUS was modeled after
high-option Blue Cross in our 1966 authorizing legislation.
No. 2, the components of the Public Health Service— NIH, et
cetera, but basically a Public Health Service opinion would be the
one that we would go by.
No. 3, the AMA Council on Scientific Affairs. CHAMPUS itself is
too small a program to afford the cost of duplicating the above pro-
grams. It would probably cost us on the order of $500,000 to set up
a technology assessment unit capable of dealing with all the new
advances in medicine and surgery, so therefore we rely on the PHS
to give us that information and those judgments.
Question No. 2: Is liver transplantation experimental or standard
therapy? Blue Cross said that it was still experimental at their
560
March 1983 health policy meeting after hearing testimony from
various medical advisers.
The AMA Council on Scientific Affairs has not taken a position.
The Public Health Services will have an NIH consensus confer-
ence on liver transplantation this June, as Dr. Brandt indicated in
his testimony. We will follow the PHS guidance that arises out of
that process.
In summary, none of the above technology assessment groups
have to date endorsed liver transplantation. So, for the time being,
CHAMPUS must assume it is experimental.
Question No. 3: Is what can we do to help Adriane Broderick. As
I mentioned, we cannot pay for the surgical procedure itself, for
reasons mentioned above. However, we do pay for hospitalization
and other expenses related to her illness.
As we have done in other experimental transplant cases, we will
assist the family in fundraising techniques to deal with the bal-
ance. With Captain Broderick, for example, the CHAMPUS has
provided guidance on fundraising, community resources, running
an appeal, and managing an appeal account.
In the area of heart transplants, there are specific centers with
research funds available, and our staff has frequently assisted with
these arrangements. The Air Force has provided transportation to
and from such centers under its aero medical evacuation program.
Military organizations such as the Wives Club and the Army
Relief Association have invariably provided loans or gifts to cover
sizable portions of the bills not covered by CHAMPUS or not dis-
counted or forgiven by the civilian hospital or civilian surgeon.
Finally— and this does not appear in my formal statement there
but is stimulated by reading the concerns in the transmittal letter
from you and Mr. Skeen— I have asked for a review of the military
hospital organ procurement policy, and the Health Affairs staff has
this review under way.
We will be soliciting comment and advice from your committee,
the voluntary agencies, and Dr. Koop's people, with the following
outcome in mind— to generate an action item for the Defense
Health Council so that we can, systematically bring our assets to
bear on this problem.
We have 10 million beneficiaries in the military hospital system
itself, 12,000 doctors and 161 hospitals. So I hope, by approaching
this systematically, we can come up with a very reasonable pro-
gram to contribute to the shortage of organs that has been de-
scribed in the preceding hearings.
So, in conclusion, I will pledge my personal support to this effort
and keep your committee fully informed.
Thank you.
[Prepared statement of Dr. Beary follows:]
561
STATEMENT OF
JOHN F. BEARY, III, M.D.
ACTING ASSISTANT SECRETARY OF DEFENSE
(HEALTH AFFAIRS)
Mr. Chairman and Committee Members:
Thank you for the opportunity to comment on DoD's policy on organ
transplants. The Defense Department operates 161 hospitals worldwide to serve
some 10 million military personnel, retirees, and families. When military
families can't get their medical care in the Services' treatment facilities,
the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)
shares the costs of care from civilian providers. So, we are involved with
organ transplantation both as a direct provider of care and as the operator of
a health benefit plan.
Adriane Broderick, one of the children here last week, is awaiting a
liver transplant. Because her father is a career member of the Armed Forces,
we in the Defense Department are particularly concerned. As the father of two
young children, I can well understand the anguish of her parents and
grandparents .
Our Office of General Counsel has advised me that it would be legally
objectionable to pay for experimental medicines and surgery, until such time
that medical researchers prove that a therapy is effective and that it is not
more likely to harm the patient than to help.
Given the above restrictions, the issues before us are:
1. How does CHAMPUS determine policy on whether a therapy is
experimental or standard?
2. Is liver transplantation experimental or standard therapy?
3. What can we do to help Adriane Broderick?
TECHNOLOGY ASSESSMENT FOR CHAMPUS
We accept the findings of:
A. The Blue Cross Medical Policy Council (CHAMPUS was modeled after
high-option Blue Cross in our 1966 authorizing legislation).
562
B. The components of the Public Health Service, including NIH, FDA, AND
OHTA.
C. AMA Council on Scientific Affairs.
D. CHAMPUS is too small a program to afford the cost of duplicating the
above programs.
IS LIVER TRANSPLANTATION EXPERIMENTAL OR STANDARD THERAPY?
A. Blue Cross said it is still experimental at the March 1983 Health
Policy meeting.
B. AMA Council on Scientific Affairs has not taken a position.
C. Public Health Service (NIH) will have a conference on liver
transplantation in June as Dr. Brandt indicated in his testimony. We
will follow the P.H.S. guidance.
In summary, none of the above technology assessment groups have to date
endorsed liver transplantation. So for the time being, CHAMPUS must assume it
is experimental.
WHAT CAN WE DO TO HELP ADRIANE BRODERICK?
A. We cannot pay for the surgical procedure itself for reasons mentioned
above. However, we do pay for hospitalization and other expenses related
to her illness.
B. As we have done in other experimental transplant cases, we will
assist the family in fund raising techniques to deal with the balance.
With Captain Broderick, for example, the CHAMPUS staff has provided
guidance on fund raising, community resources, running an appeal, and managing
an appeal account.
In the area of heart transplants, there are specific centers with
research funds available; and our staff has frequently assisted with these
arrangements. The Air Force has provided transportation to and from such
centers under its Aero Medical Evacuation Program. Military organizations,
such as the Wives Clubs and the Army Relief Association, have invariably
provided loans or gifts to cover sizable portions of the bills not covered by
CHAMPUS or not discounted by civilian hospitals.
Mr. Chairman, I hope that this clarifies the CHAMPUS position.
Thank you.
563
Mr. Gore. Thank you, Dr. Beary.
Dr. Koop, you said that you, as a pediatric surgeon, were quite
familiar with biliary atresia, and you said that when a child truly
has biliary atresia, there are only two alternatives, either trans-
plant surgery or death.
Do you believe that transplant surgery, in the case of a child who
will die without it, that the procedure is more likely to harm than
to help the child?
Dr. Koop. The immediate benefit would certainly be to the
child's advantage. The thing that we do not know, sir, is what the
long-term effects are.
We do not know, for example, how long a child must stay on im-
munosuppressant therapy. We know we are creating a problem be-
cause immunosuppression itself is a real concern to the Public
Health Service.
We do not know what the carcinogenic activity is of the immuno-
suppressive drug cyclosporin A because we haven't used it long
enough.
So, in the long term, I really could not answer that question, sir,
as to whether it would be beneficial or whether it might, in the
long term, be harmful.
Mr. Gore. Well, the child is going to die without it.
Dr. Koop. That is true. There is no question about that, but we
do hesitate before we take a stand to have some information about
what we can advise people about the long-term concerns about
cancer and immunosuppression.
Mr. Gore. Well, the child has a chance with the surgery. The
child is going to die without the surgery. How can you say that it
might be more likely to hurt than to help?
Dr. Koop. Well, I think another aspect of this, sir, that has to be
taken into account is the patient himself, how his biliary atresia
has affected him, how wide or narrow a window you have to do this
procedure, because all children with the same diagnosis do not die
at the same rate; they do not have the some complications.
Given 100 such children, under normal circumstances, without
any help, 50 percent die in the first year, 25 percent die in the
second year, and then the remaining 25 percent go on. I had one
child live, years ago, as long as 9 years. It seems almost impossible
to do that without bile drainage, but nevertheless, it happened.
Mr. Gore. And then what happened?
Dr. Koop. Then he died.
But it is very difficult to speak generically about all biliary atre-
sia because the patient selection has to be very, very carefully
done.
Mr. Gore. Do any of them live a normal life?
Dr. Koop. No, sir.
Mr. Gore. They all die?
Dr. Koop. They all die.
Mr. Gore. And we have figures that the transplant procedure is
now effective in 70 to 80 percent of the cases where it is used. Do
you have any reason to disagree with that percentage?
Dr. Koop. No, sir; I only know what I hear from the transplant-
ers.
564
Mr. Gore. OK, so we have two choices here. Without the surgery,
100 percent of them are going to die. That is correct, right?
Dr. Koop. That is correct, sir.
Mr. Gore. With the surgery, 70 to 80 percent will live. And yet
the Government tells us they cannot decide whether or not the pro-
cedure is more likely to hurt than to help. That just doesn't make
sense.
Dr. Koop. I don't think that we have told you we cannot decide,
sir.
Mr. Gore. Well, let me refer you to Dr. Beary's statement. I am
quoting from page 1.
Our Office of General Counsel has advised me that it would be legally objection-
able to pay for experimental medicines and surgery until such time that medical
researchers prove that a therapy is effective and that it is not more likely to harm
the patient than to help.
Why is there any doubt about the fact that liver transplants are
more likely to help than to harm?
Dr. Koop. Let me answer that question, and then I will ask Dr.
Brandt to expand upon it.
We have been aware of this, sir, for a long time, and the reason
that there is a consensus conference is because we recognized that
there was a need for a decision.
With liver transplantation, I think it is fair to say that the state
of the art has moved along much more rapidly than is ordinarily
the case in technology transfer to clinical medicine.
But, having planned a conference with all of these international
experts who know much more than I do about this situation, I
think it would be improper for me to make a statement flatfootedly
now until that consensus conference has come to a close.
Mr. Gore. Now, there are some children that may well die be-
tween now and then, and this has been going on now for, what, 15
months?
Dr. Brandt. No, sir.
Mr. Gore. A year?
Dr. Brandt. It has been going on approximately a year. But I
think that you have to consider that at this point in time, there is
no clear definition regarding the selection of patients. There is no
clear definition of what the time period ought to be. In other
words, when should the liver transplant be performed? There is no
clear criterion for the quality or the condition of the liver.
Let's not forget that in the case of a child receiving a liver trans-
plant, one child dies, namely, the donor. The problem of trying to
determine what the criteria are for that liver to be transplantable
we still don't know the answer to many of these questions.
Our role in this, as we see it, is the issue of trying to determine
the answers to some of those questions. Admittedly, there has been
a lot of information that has accumulated in the last year, and we
are fully prepared now, I believe, to go into that conference, to
bring in all of the experts from around the world, to begin to deter-
mine the answers to some of these questions, so that we can come
out with a series of recommendations that will be of the greatest
benefit to the greatest number of people.
565
Mr. Gore. Well, Dr. Beary, let's talk about Adriane Broderick.
Her doctors tell this subcommittee that she is going to die unless
she has a liver transplant.
The facilities where the transplant will take place, hopefully, say
they cannot perform it until her father's insurance plan agrees to
pay for it. Her father, unfortunately, is on active duty with the
U.S. military. I say unfortunately because if he had a private insur-
ance plan, if he had one of most of the private insurance plans, his
daughter's life could be saved. But he is covered as an active-duty
military officer by CHAMPUS.
I had reason to believe, and the subcommittee had reason to be-
lieve, that in response to the letter that Congressman Skeen and I
sent to the Secretary of Defense, DOD was prepared to change its
policy. We were informally advised that such a change was under
way.
However, you tell us this morning that such a change would be
"legally objectionable," according to your Office of General Coun-
sel.
Now, you tell us that the Army Relief Association and the Wives
Clubs will have a fundraising drive and that you are going to give
Captain Broderick advice on how to mount a public fundraising
appeal in order to save his daughter's life. Yet you will not pay for
the surgery.
You will pay for all of the care his daughter needs as she dies.
Experts have told us that the costs of that care often far exceed the
cost of the transplant procedure which can save her life.
I find your testimony extremely disappointing — extremely disap-
pointing.
Dr. Beary. Perhaps I could respond to a couple of your concerns.
Mr. Gore. Yes, please do.
Dr. Beary. First of all, I think we have to see where we have
some common assumptions. As we mentioned, the way title 10 is
written and has been interpreted, we are precluded from paying for
experimental surgery, and the testimony of the other witnesses has
borne that out.
I would say, if that indeed is the barrier, as it seems to me and
competent legal opinion to be, the action is in your branch of gov-
ernment. If you want to change title 10 to address experimental
surgery, you need
Mr. Gore. Now, wait a second. On what basis have you concluded
that this is experimental surgery?
Dr. Beary. By the absence of a credible national body such as the
three I have mentioned to come to a consensus or a conclusion
about the matter.
Mr. Gore. You cite Blue Cross, and yet Blue Cross is reimbursing
for these procedures. In fact, they are reimbursing, I believe, for
more of them than anybody else.
Do you have those figures here? Hold on a second.
In Pittsburgh, out of 19 procedures, liver transplants paid in full,
11 of them were Blue Cross.
Dr. Beary. That contradiction can be explained in the sense that
the national Blue Cross body, which discussed it at a conference in
March, said that at this point in time they are still experimental.
However, individual plans are able to do what they want to do, just
566
as individual States under medicaid are free to do what they want
to do, although PHS and HCFA, in 60 days, are setting up the con-
ference to deal with the issue definitively.
Mr. Gore. After a year of talking about it.
Dr. Beary. June is within 60 days. I think that is a reason-
able
Mr. Gore. Well, she may not have that long to live. You under-
stand that.
Dr. Beary. I have not been involved in her direct care, so I
cannot comment on the specifics of her case.
Mr. Gore. What kind of advice are you going to give Captain
Broderick on fund raising? Are the recruitment advertising people
going to be called in?
Dr. Beary. Well, I think that is a rhetorical question, sir.
Mr. Gore. No, I am quite serious.
Dr. Beary. You may as well answer it yourself.
Mr. Gore. No, sir. I am quite serious. Have you got a plan to
Dr. Beary. Yes, we have a serious plan.
Mr. Gore. And what does it involve? Public appeals?
Dr. Beary. I will have to supply details for the record. I don't
have the details at my fingertips, but I certainly can supply that
for you.
Mr. Gore. I wish you would supply those details for the record.
Dr. Beary. I will do that, sir.
[The information follows:]
If beneficiaries and their families indicate a desire, as have the Broderick's, to
have a liver tansplant done on their child, CHAMPUS will share with them advice
on fund raising and the location of possible research funds that it has collected
through the years. The information consists of such items as types of community
activities that have been found to be successful, how to set up and maintain a tax-
free account and how to approach the media.
This assistance does not, however, ordinarily require the Department to incur any
incremental costs. The services are generally provided by people whose jobs already
include assistance with morale, welfare, and health related problems. These individ-
uals are simply asked to add to their activities assistance to those who seek to take
advantage of investigational medical procedures that are not covered under the
health benefits provided to DOD beneficiaries.
Mr. Gore. I would like to explore this a little bit with you now.
Are you going to have television commercials?
Dr. Beary. I will supply all the details for the record. I would not
want to decide on the spot on a level of detail of that sort.
Mr. Gore. How much money do you expect to spend on the fund
raising plan?
Dr. Beary. I have no additional information on the details
beyond what I gave you. The letter from your committee did not
imply that you were going to be interested in that level of detail.
Mr. Gore. Well, it is the only alternative for this child whose life
is in danger at this point.
How much do you expect from the Wives Club?
Dr. Beary. Well, there is another alternative. If your committee
wants to change title 10 and pass an appropriation for it, we are in
business.
Mr. Gore. How much do you expect that he can raise from the
voluntary fund raising drive?
567
Dr. Beary. Well, perhaps I could illustrate it with an example,
with a recent heart transplant case we had in Arizona. CHAMPUS,
as I said, can pay for any aspects of the illness that are reasonably
related to the illness.
As you have heard from all of the witness, law precludes us from
paying for the surgical fee itself or the operating room or anesthe-
sia fee itself. However, we try to certainly give the patient the
benefit of the doubt on anything where there is a judgment call,
and in this particular case in Arizona that Representative Michael
was involved in, they were able to raise enough funds so that there
was actually a balance left in that particular case.
So I am not as pessimistic as you are about the efficacy of those
things. Until Congress changes its guidance on this matter, in my
branch of the Government, we have to follow the law as it is writ-
ten.
One hundered four thousand dollars was raised in Arizona.
Mr. Gore. Are you going to provide assistance in mounting a
public relations and fund raising drive for the other uniformed mil-
itary personnel whose children are waiting?
Dr. Beary. Certainly. We will have a uniform policy and guide-
lines that will apply to all of the men. Anything we can do within
our power, we will do. Obviously, our first interest has to be that of
the beneficiary, but, as you well understand, there are laws that
guide just exactly what we can do.
It is a complex issue. One would want to decide very carefully
before deciding to have, say, a carte blanche thing on reimbursing
for experimental therapies.
Mr. Gore. Well, I don't see it as particularly complex in this in-
stance.
Dr. Beary. Well, do you agree it is experimental or not? I am not
sure we are communicating on that.
Mr. Gore. Well, I want to get to that, but before I do, let me ask
you, how many other children of uniformed military personnel cov-
ered by CHAMPUS are currently suffering from biliary atresia and
in need of liver transplants?
Dr. Beary. I will have to supply that information for the record,
also.
[The information follows:]
Mr. Chairman, I can only report on the number of families who have asked
CHAMPUS to cost-share liver transplant operations.
Because the CHAMPUS program is designed to adjudicate and cost-share health
care services provided to its beneficiaries, the only way that CHAMPUS can become
aware that a beneficiary has recevied a service, or needs to receive a service, is
when a claim is submitted for payment, or when a beneficiary inquires if a service
is covered.
To date CHAMPUS is aware, through these two mechanisms, of requests for liver
transplants for: 1. Adriane Broderick; 2. Aaron Polhemus; 3. Michael Rasdon; and 4.
Frank Silcox, Jr.
Mr. Gore. We are informed that there are seven.
Dr. Beary. It is feasible.
Mr. Gore. It is feasible. And you will provide assistance in
mounting a public fundraising drive for the families of all seven, is
that correct?
Dr. Beary. Certainly, we will supply all patients with the same
approach, same type of assistance we would give any other patient.
568
Mr. Gore. How many children of military personnel have al-
ready died because CHAMPUS refused to pay for the procedure to
save their lives?
Dr. Beary. And the Congress refused to change title 10; to cover
it. I don't have the answer.
Mr. Gore. Well, you keep inserting title 10; Dr. Beary.
Dr. Beary. What does your counsel say?
Mr. Gore. Dr. Beary, please let me conclude my question, if you
would. You keep inserting title 10; but the word "experimental" I
do not think can fairly be used to describe a procedure that has a
70- to 80-percent success rate.
The real issue here is how quickly the bureaucracies represented
at the table can adjust to changed circumstances.
As Dr. Koop stated, the progress where liver transplantation is
involved has been more rapid than is usually the case with new
medical procedures. The introduction of cyclosporin A and the dra-
matic increase in surgeons' skills have jumped the success rate
from the 30-percent range up to the 80-percent range in a very
short period of time.
And yet the bureaucratic organizations that are charged with
evaluating medical procedures have been slow to react. We are
right now— well, let me give you an example. In July 1981, an edi-
torial in the British Medical Journal, with which I am sure Dr.
Koop and Dr. Brandt are familiar— the publication of the British
Medical Society back in July 1981 published an editorial headlined
"Liver Transplantation Comes of Age " almost 2 years ago.
It concluded as follows: "It gives a chance of excellent rehabilita-
tion for patients with no other treatment available, and the oper-
ation is probably less costly then prolonged care of a patient dying
of liver disease."
Now, that is almost 2 years ago, and the medical community has
known this. It is fair to say that this is a more rapid advance. But
to label it experimental in the spring of 1983 is just unreasonable.
Now back to my question, Dr. Beary. You don't know how many
children of military personnel have died while awaiting this proce-
dure—has your staff provided you with that information?— because
CHAMPUS refuses to pay for it?
Dr. Beary. No, sir.
Mr. Gore. We have heard that there are at least two, and that
they are currently suing the Department of Defense. Does your
counsel have knowledge of ongoing lawsuits of that kind?
Dr. Beary. We have no knowledge of that.
Mr. Gore. All right; we will elaborate on that for the record and
give you an opportunity to do so as well. We have heard that
there are two children of active-duty military personnel that have
died of biliary atresia, principally because they were unable to pay
for the operation and get on the list, and the reason they were
unable to get on the list is because the U.S. Government, the
CHAMPUS program, was unwilling to pay for it.
[The information follows:]
Mr. Chairman, our counsel has no knowledge of any on-going lawsuits related to
liver transplants.
569
Mr. Gore. Dr. Brandt — and I am just going to ask a couple more
questions and then recognize my colleague and come back for an-
other round — first of all, would you agree that this procedure, liver
transplantation, has improved in its efficacy much more rapidly
than is usually the case for new procedures?
Dr. Brandt. I think so — and I would not limit it just to liver
transplants — largely because, I think, of the development of cyclo-
sporin A.
As you pointed out, prior to cyclosporin A, the 1-year survival
rates — and I think you need to continue to emphasize that the
number of children that have had liver transplants over a pro-
longed period of time, in this country, largely prior to 3 years ago —
was very small; so we really only know the survival rate for that
short period of time. But that rate, as you point out, has increased
dramatically. As you know, we received a new drug application for
cyclosporin A from the sponsor in November 1982 — that is 5
months ago — and we are in the process, in the final stages, of eval-
uating that drug to make it available.
So we are talking about the use of an experimental drug that has
made, in large part, this dramatic change. I think it has moved
rapidly; I agree with you.
Mr. Gore. It has been widely available for quite some time and is
used in all of the centers doing the transplant surgery.
Dr. Brandt. Yes, as an investigational drug. That is correct.
Mr. Gore. Dr. Koop, you are known as a man of integrity and
sensitivity, great attention to problems of medical ethics and the
like. If you had a patient with biliary atresia, would you be reluc-
tant to prescribe a liver transplant?
Dr. Koop. Well, I have been in that situation, sir, a number of
times. I finished my active practice in March 1981. A lot of this has
happened since then.
Mr. Gore. Yes.
Dr. Koop. But I would say that in the years that, say, Dr. Starzl
first began doing this sort of thing, I must have had 20 patients
that today might be considered suitable for transplant, and I only
felt that two of those, because of their other medical conditions,
were suitable for referral, and neither one of those did Dr. Starzl's
team think were suitable for referral.
That is what I meant before, that you just cannot talk about
liver transplants generically. There were about 20 children that
never were even offered for transplant because of a decisionmaking
process with a lot of medical expertise.
Mr. Gore. Well, let me rephrase the question, then. If the child's
pediatrician and the consulting specialist told you that a liver
transplant was indicated and had a good chance of saving the
child's life, you certainly would not stand in the way of that child
receiving a liver transplant.
Dr. Koop. Well, we still don't know the criteria, sir. Many times
I have done myself, or referred elsewhere, patients to have things
done upon them which were indeed experimental. The fact that
something has come of age does not mean that it necessarily is now
to the point where you can discuss every single case and say these
are the criteria, this is what we expect, and this is how it will go. It
is not just open and shut.
570
Mr. Gore. Well, for many of these children, it is.
With biliary atresia, you may receive benefit from another oper-
ation, as you know, introduced from Japan, the Kasai procedure.
Are you familiar with that?
Dr. Koop. I trained Dr. Kasai, sir.
Mr. Gore. That is what I was getting at. [Laughter.]
I understand that it benefits only a small number of patients,
correct?
Dr. Koop. That is true.
Mr. Gore. But those it benefits, it provides real benefit.
Dr. Koop. No, it really does not. I think the long-term results in
Dr. Kasai's hands are perhaps the best of any place in the world.
Two other Japanese surgeons have done not quite as well but
almost as well. The results in this country seem to be sporadic.
But I have to tell you that there are many of us in this field who
believe that there are different aspects of liver disease among Ori-
ental children than among Caucasian children, which may account
for the differences in result.
Mr. Gore. Would you say the Kasai procedure is experimental?
Dr. Koop. Oh, I think definitely.
Mr. Gore. Dr. Beary, is the Kasai procedure paid for by CHAM-
PUS?
Dr. Beary. Dr. Rodriguez?
Dr. Rodriguez. To our knowledge, it is not.
Dr. Beary. To our knowledge, it is not.
Mr. Gore. Well, to our knowledge, it is. Captain Broderick's
daughter received the Kasai procedure, and it was paid for by
CHAMPUS. It is also routinely accepted and paid for by private in-
surance carriers and by medicaid without question.
Dr. Koop, by what process was it determined that the Kasai pro-
cedure was acceptable and thus eligible for reimbursement?
Dr. Koop. Well, I can explain that to you, sir.
We have to start with a jaundiced baby. All children are born
looking unjaundiced, but those who have problems that lead to
jaundice develop it within the next 3 days. Some of these are medi-
cal reasons for jaundice, some due to hematological problems.
When you realize that you have persistent case of jaundice that
is probably due to the obstruction of the biliary tract either inside
the liver or outside of the liver, there is no definitive way to make
that diagnosis without doing an operation.
At that operation, you might find a rare patient who has a rem-
nant of a bile duct that could be hooked up to his intestine, and he
would be essentially cured, barring unforeseen complications.
Then you have maybe three or four other options of things that
could be done as a surgeon. One of those options would be the
Kasai procedure. But when you talk about whether the Kasai pro-
cedure per se is paid for, in my own experience, I would put that
down on my insurance form sent to the insurance carrier as explor-
atory laparotomy for the diagnosis of obstructive jaundice, and it
might cover three or four different operations.
So you might ask this question in a way where the answer is
"yes, they pay for a Kasai procedure, or you could ask it in a way
where the answer is no, they don't pay for a Kasai procedure.
Have I made that clear? It is complicated.
571
Mr. Gore. It is complicated.
The process that you went through, Dr. Davis, is also complicat-
ed, the process for determining when something is approved.
Don't you think it is fair to say that your procedure for evaluat-
ing this new technology has been too slow?
Dr. Davis. No; I believe that our procedure has a great deal of
integrity to it. We do move expeditiously. But we also believe that
we need to take into consideration a number of factors which both
the Surgeon General and the Assistant Secretary for Health have
outlined. We rely very heavily on expertise from the Public Health
Service.
Mr. Gore. Are you familiar with the analyses presented to the
subcommittee 2 weeks ago showing that the cost of a lingering
death, where patients with biliary atresia are involved, exceeds the
cost of the transplant, so that you are not only allowing them to
die; you are also wasting the taxpayers' money in the process. Are
you familiar with those analyses?
Dr. Davis. I did read that material.
Mr. Gore. What was your reaction?
Dr. Davis. My own reaction in terms of the medicare program is
that, again, it is still an experimental procedure, and the fact that
one age group, as I indicated, may appear to benefit more than an-
other one is one of the dilemmas that we are in. That is one of the
reasons why we ask the Public Health Service to help us make a
decision on coverage. It really involves the feasibility of establish-
ing the criteria, because we don't want to be discriminatory, and
yet, on the other hand, we know just from the experimental mate-
rial that is already available that organ transplantation appears to
be more useful for some than for others.
So it really becomes a question of where should it be performed,
if it should be performed, and upon whom in terms of safety and
efficiency.
Mr. Gore. One more question. Dr. Beary, are you familiar, just
isolating the child population for a moment, are you also familiar
with the studies indicating that by allowing these children to die,
you are simultaneously wasting money?
Dr. Beary. I haven't reviewed that for the basic reason that that
data would have no impact on any decision I make. If the PHS ap-
proves this as standard therapy, I will cover it. I just cannot afford
one-half a billion dollars to do my own technology assessment.
Mr. Gore. Where do you get the figure of one-half a billion dol-
lars?
Dr. Beary. Well, that is about what it would cost DoD to dupli-
cate the PHS health technology assessment setup, because, of
course, we wouldn't do it just for
Mr. Gore. Do you rely on Dr. Davis?
Dr. Beary. Well, Dr. Brandt, I believe, speaks for the head of the
PHS.
Mr. Gore. Ok; well, Dr. Brandt, are you familiar with the analy-
ses that show that where children are involved, leaving aside Dr.
Davis' adult population for a moment, are you familiar with the
studies showing that where children with biliary atresia are in-
volved, by allowing them to die and refusing to pay for the trans-
572
plants, you are also wasting the taxpayers' money at the same
time?
Dr. Brandt. I have seen the data that was presented to you, sir,
and am aware of that. However, at the present time, we do not
take costs into account in determining whether or not treatment is
of general applicability. If we did that, then, of course, that would
quickly lead to a ceiling, and we would not evaluate high-priced
technology. We will not be taking the cost of the procedure in to
account in trying to come to this decision.
Mr. Gore. Well, I am going to cool off and think up some more
questions while I recognize my colleague. [Laughter.]
But what we have here is an absolutely absurd situation, and it
is very frustrating. Most all the private insurance companies recog-
nize that this is no longer an experimental procedure. Most of
them are reimbursing for it.
We have testimony showing that there is a 70- to 80-percent suc-
cess rate with these procedures. We have testimony showing that it
is cheaper to save their lives and go forward with the transplant
than it is to pay for all the care needed during a lingering death,
which you presently approve.
And yet the Government bureaucracies represented here abso-
lutely refuse to recognize what is obvious to the medical experts in
the field, and it is extremely frustrating. That is a slow, slow proc-
ess that is cranking along toward the consensus conference in
June, and then there will be an evaluation. It has been going on
for 1 year already. And, in the meantime, these children need the
money, and in its place we have the, I think, bizarre spectacle of
the Defense Department providing public relations guidance to
mount public fundraising drives for the children of the military
personnel that need these procedures to save their lives. There is
something bizarre about that.
Dr. Brandt. Mr. Gore, if I could comment 1 second on that. You
have the testimony of a limited number of people thus far. You
made the statement that medical experts agree that this is a stand-
ard procedure.
We are bringing in people from all over the world who have
great experience in looking at this whole issue from the ground up.
I don't think it is fair to say that, on the basis of the testimony
before this subcommittee, you can conclude that all of medicine
will agree with that.
Mr. Beary. I would reinforce Ed's comment if I could. If one lis-
tens only to advocates of a procedure, it is not surprising you get a
unanimous endorsement. But there are some people who will be
heard from at the NIH conference who are skeptical. I would not
want to characterize their outcome or findings, but there have been
questions raised about the immunosuppression. The heart trans-
plant literature, as you probably have been following, shows that
there may be Kaposi's sarcoma and AIDS-like illnesses showing
up
Mr. Gore. Look, speculation about possible complications later in
life as a result of immunosuppression is not of that much relevance
to a child that is going to die very soon without the procedure m
question.
573
And to say that we have only heard one side, how do you explain
the conclusion almost 2 years ago by the British Medical Society?
Dr. Brandt. Well, you quoted from an editorial written by an
editor of that journal. That is correct.
Mr. Gore. By the Journal of the British Medical Society.
Dr. Brandt. That is correct, yes.
Mr. Gore. Congressman Skeen?
Mr. Skeen. It is about time to give our chairman a little rest
here.
Mr. Gore. Yes.
Mr. Skeen. He is becoming overwrought. [Laughter.]
Aren't you glad you are here today? [Laughter.]
I want to turn this around a little bit and let's take another tack.
I think that several of the questions that were asked earlier would
give a good indication that maybe it is time for us to sit here and
listen, rather than ask all these great questions, and I am not
being critical. I think that what the chairman has brought out has
been very significant, good questions, and it goes to the heart of the
problem.
We are all displaying a great compassion for this problem, and I
don't think there is a person in this room that can sit back there
and look at that child that is in the back of the room doing the
crying a while ago and not feel a very strong compulsion to do ev-
erything possible to make modern medical technology arailable to
all those in need. But there are ways to do it.
I want to start with Dr. Beary. I really have a little problem with
the statement about legally objectionable. Can you explain to me
what the Office of the General Counsel was talking about, in specif-
ics?
Dr. Beary. If it would be agreeable, I might let Mr. Gilliat ad-
dress that himself, since he was involved in the review of that
issue.
Mr. Skeen. I would like very much to hear it. What do you mean
by legally objectionable, and at what point do we reach the point of
knowing that this is an effective procedure and it is no longer ex-
perimental. I think the two are tied together in the same state-
ment.
Go ahead, Mr. Gilliat.
Mr. Gilliat. Yes, I will attempt to explain it.
The Department of Defense is bound, of course, by its own regu-
lations in implementing the rather broad language of chapter 55 of
title 10, which authorizes CHAMPUS.
Those regulations prohibit payment for those kinds of procedures
which are labeled experimental. The definition of experimental in-
cludes those procedures which are investigational.
The question then naturally follows, Why can't the regulations
be changed? Could they be changed in a manner that would permit
this?
In determining whether a regulation can be modified to include
a procedure, we look to the high-option benefit Blue Cross available
under the Federal employees health program. It is our understand-
ing that under the high-option Blue Cross plan for Federal employ-
ees, liver transplants are not paid for.
23-029 0-83-37
574
Therefore, we have no legal authority, by reason of the legisla-
tive history of the 1966 amendments of chapter 55, which serves for
us as a touchstone in determining the legality of what we do and
what we provide, that is, the provisions of that high-option plan.
Does that explain it, sir?
Mr. Skeen. That gives me a better idea.
Now, what would be your recommendation to us? This is your
chance to tell the legislative body. You know, I have a deep-seated
suspicion that a lot of the times when we jump ^n the regulatory
agencies, part of the problem lies right here in Congress. We talk
about you being slow in responding to a problem. Take a look at us.
What would you recommend insofar as regulations — I think Dr.
Beary alluded to chapter 55 of title 10? What changes would you
need in title 10 to facilitate CHAMPUS' response to organ trans-
plants?
Dr. Beary. Basically, it would need to be an amendment that
would say "experimental medicines and surgery are covered."
Mr. Skeen. Go ahead and just cover them?
Dr. Beary. Yes.
Mr. Skeen. In other words, do away with the experimental classi-
fication insofar as organ transplants are concerned.
Dr. Beary. Cover everything that people want to make a case
for.
Now, the hazard of that is, just to list some things that had advo-
cates at one time but fell out of favor, you may recall the internal
mammary artery revascularization of the heart, where they took
an artery and tried to restore circulation of the heart before the
coronary bypass that we use now came into being. There was irra-
diation for enlarged tonsils and adenoids, which later turned out to
cause cancer of the thyroid.
In today's issues, we have DMSO for arthritis and laetrile for
cancer. So it is a very controversial area that one would be getting
into, and one would want to approach it carefully. But that would
be the authority we would need to be able to compensate for things
before one of the national bodies such as Public Health Service
makes a determination on it.
Mr. Skeen. Dr. Beary, what if you reduced and focused more on
the types of surgery, those that the experimentation — say, limiting
it to various types of organ transplants that you indicate rather
than those that are rather highflown and still very much experi-
mental?
Dr. Beary. Well, I wonder if I might suggest an option here.
Mr. Skeen. Sure.
Dr. Beary. Possibly, given what the NIH mission is, to advance
science, and so forth, maybe it would make more sense to fund
fully a few regional centers. There are only two or three places in
the country, for instance, doing liver transplants.
If it were the desire of Congress to do more in this area, rather
than proliferate the technology to areas where people — I mean,
surgery is like anything else: If you don't do a lot of it, you don't
get too good at it. And so it might make sense to keep it in those
centers where there is a reasonable track record, but just be sure
the funding is there to take care of whatever demand for whatever
575
particular category of illness it was the desire of Congress to cover,
be it livers, hearts, or what have you.
But the NIH would seem to be a mechanism in place already, if
the funding were provided to be able to provide those services until
science had made a determination on whether it had passed from
experimental to standard therapy.
Mr. Skeen. Do you have some idea of the level of funding?
Dr. Beary. I do not; I think that would probably be a question
that Dr. Brandt or HCFA might have an order of magnitude for
the Nation's needs in that area.
Dr. Brandt. Well, if you are talking only about organ trans-
plants, sir, that is one kind of question. If you are talking about
assessment of
Mr. Skeen. Let's just say organ transplants.
Dr. Brandt. Well, I do not know. I can certainly supply the in-
formation to you about the total costs that we are undergoing to
evaluate these.
Mr. Skeen. I would be very interested in having that for the
record.
[Material to be supplied follows:]
In the area of liver transplants, PHS estimates that it will cost approximately
$100,000 to conduct an assessment. This includes the cost of the NIH consensus de-
velopment conference (approximately $85,000) and the staff time of the Office of
Health Technology Assessment of the National Center for Health Services Research
(approximately $15,000). This, of course, does not take into account the cost of devel-
oping the data or the research which was used in the evaluations.
Mr. Skeen. I share the chairman's concern, too. I think there is
an irony in the situation that we are willing to finance under var-
ious programs — but I can understand how we got in that position —
those that are terminal, which are far more costly than just the
transplant technology.
But until the Congress of the United States helps change the reg-
ulations, there is not a whole lot that you can do with it and stay
within the guidelines. Am I mistaken?
Dr. Beary. That is an accurate reflection of the Defense Depart-
ment's position.
Mr. Gore. Will my colleague yield?
Mr. Skeen. Surely.
Mr. Gore. The difference between the decisionmaking process in
the administrative branch and in the Congress, I think, is pro-
found.
In writing the laws, we have to use categories like "experimen-
tal," and then rely upon the experts in the administration to come
up with an accurate definition, with an accurate judgment, on
what is experimental and what is not.
Now, if they were incapable of doing so, then, in a case like this,
for example, we could write specifically in, "Liver transplants are
no longer experimental." But what is so frustrating is that the ma-
chinery and the process for deciding when something is no longer
experimental in the light of dramatic new advances, like cyclo-
sporin has made possible, if that does not proceed in an expeditious
fashion, you get this kind of intolerable result that we have here
today.
576
So the real upshot of this hearing ought to be a revamping of the
procedures by which the executive branch decides what is experi-
mental and what is not. Clearly, we have a procedure here— in my
view, it is clear — that is no longer experimental, even if it is still
labeled such.
Mr. Skeen. I agree with you, Mr. Chairman, and what I am
trying to get from these folk today is suggestions to us on how you
change that procedure, because if I were an administrator sitting
out there today, and I went to my general counsel, which most of
you h- re to rely on, and that counsels says, "You can't do that,"
then the old armadillo complex comes into play, and you roll up in
a ball and make sure that you are not going to get shot with an
arrow, particularly from congressional groups, because we are just
as happy to expedite your work as we are to impede it.
Maybe that is part of the problem, that we have not given you
the flexibility. That is, how do we build some kind of sanity into
this system so that the bureaucracy can react as administrators?
I agree with the chairman; you are supposed to have that kind of
determination. But once again, knowing how the procedure works,
once you arrive at a new technology and a new technique and a
whole new area, you rely on your counsel, as far as I can see, and
this is, I think, the case here, Dr. Beary, and I don't know whether
Dr. Koop, Dr. Brandt, and Dr. Davis feel the same way.
Go ahead.
Dr. Brandt. Congressman, could I address that for a moment?
Mr. Skeen. I would like very much to hear you.
Dr. Brandt. There are several aspects. In the first place, I would
like to point out that CHAMPUS has decided to rely upon three
expert bodies in this country for decisionmaking. None of those
three has yet declared that this procedure is not experimental.
Second, in this country, we have no defined accepted process for
assessing new medical technology except devices and drugs which
go through the FDA as a regulatory agency to determine that
drugs and/ or devices are both safe and of value.
The Public Health Service's responsibilities in this area are lim-
ited to determining for medicare. Let me again emphasize that
medicaid can pay for liver transplants right now in any State that
opts to do that. In fact, a number of States, or some States, at least,
have determined that they will pay for it.
Mr. Skeen. As a matter of fact, that has become almost the
normal procedure.
Dr. Brandt. I don't know precisely how many States will pay,
but there are some notable examples that will not.
But they do not wait to depend upon any kind of official determi-
nation that it is experimental or nonexperimental.
I do not argue with the fact that our process for looking at tech-
nology assessment needs reexamination. To that end, over 1 year
ago, we convened a meeting involving professional societies, insur-
ance carriers, and other groups to look at that whole question, and
then went with the results of that to the Institute of Medicine. We
have asked IOM along with other sponsors, including the insurance
carriers, professional societies, and others, to look at the issue.
We are assisting, as well as HCFA, in their look at the whole
process for technology assessment in this country outside of drugs
577
and/or medical devices. They have a committee which is function-
ing to look at the issue.
The first question is, Who ought to do it? My own view is that
this is not really a Federal responsibility. This is a private sector
responsibility, but one that the Federal Government should cer-
tainly participate in, because we have a fairly major stake in the
outcome of it. I have no disagreement that the process is not per-
fect I certainly would endorse that, and I have said so repeatedly. I
think steps are under way to solve that problem.
But, at the present time, with respect to the Public Health Serv-
ice's determination, medicare is rarely liable to pay for a liver
transplant in a child. Indeed, that is a State decision, and States
have the right to do that right now.
Mr. Skeen. Let me ask Dr. Davis a question in that connection.
Our focus has been on Captain Broderick's family's situation. Is
there no other way, other than CHAMPUS, if a person is in the
armed forces, that they cannot utilize medicaid or some other pro-
gram to be funded for transplants?
Dr. Davis. I am really not familiar with the other resources that
would be available in the private sector. Clearly, the medicaid pro-
gram is a State program that does depend upon one's income level
for eligibility.
My assumption would be that there probably would be no States
that would have an income level determination that would encom-
pass armed services employees. However, some 30 States do have
what they call a medically needy program, which does mean that if
medical expenses cause you to spend down to a certain point, you
would then become available for medicaid benefits. So I think it
would probably be within the private sector where the help would
be.
Mr. Skeen. Within the private sector. So then, you are not pre-
cluding the members of the armed services, because they have
chances available to them; they still are eligible for other private
sector assistance?
Dr. Davis. I am not an authority on the military component, so I
really should not speak to that.
Mr. Skeen. Well, after having members of the armed services on
food stamps, I don't know why we cannot get them declared eligi-
ble for further programs.
Mr. Gore. Get a tin cup with some captain's bars on it.
Mr. Skeen. Yes.
Mr. Chairman, thank you. That is all.
Mr. Gore. Back to these three things that CHAMPUS relies on
that you referred to, Dr. Brandt. One of them is the AMA Council
on Scientific Affairs. It has not looked into this, has it?
Dr. Brandt. Not to my knowledge.
Mr. Gore. So you are not relying on them, or CHAMPUS is not
relying on them, for a conclusion that the procedure is experimen-
tal, because they have not taken a position.
Dr. Brandt. They have not taken a position.
Mr. Gore. All right. Now, Blue Cross, the individual Blue Cross
plans, are reimbursing for these procedures. Many of them are.
Dr. Brandt. Some of them are; that is correct.
578
Mr. Gore. And in the leading transplant center, they are reim-
bursing for more of the procedures than anyone else. Right?
Dr. Brandt. I presume. I am not familiar with the data on that.
Mr. Gore. But you are relying on them for the conclusion that
CHAMPUS should not reimburse.
Dr. Brandt. I don't run CHAMPUS. I have to let the Depart-
ment of Defense decide what they are going to rely on. I was
simply pointing out that CHAMPUS has opted to rely on three dif-
ferent bodies. The Public Health Service has not yet made a deci-
sion. We have not taken a position, if you want to look at it from
that standpoint, and will when the data is all available and has
been reviewed by experts.
Mr. Gore. And the third source of advice and guidance is the
Public Health Service, which you have responsibility for, correct?
Dr. Brandt. That is correct. Yes, sir.
Mr. Gore. OK. Why has it taken a year to address this question?
Dr. Brandt. Well, it takes a fair amount of time to do three
things. One is that we held in June last year a 1-day conference
and brought in experts from around the country, and some from
overseas, to try to determine — the process that we follow is first to
invite all— to publish in the Federal Register a notice that we are
looking into it, to invite all relevant scientific societies to provide
us with any information.
At the same time, we held a 1-day conference with experts in
June of 1982, with experts from around the world, to try to deter-
mine whether or not the data were adequate to make a judgment.
They determined it was not and that, therefore, a consensus confer-
ence was indicated.
In order to get the best minds that we can get from around the
world, we have gone through a process of defining the questions on
the basis of the data that we have, collecting the kind of informa-
tion necessary. One of the key elements, don't forget, is cyclosporin
A, and at the time that all of this planning was going on, we did
not even have a new drug application with respect to that agent.
Therefore, we needed the kinds of studies that the sponsor was car-
rying out in order to try to determine those things, since that drug
was key.
So we are now planning on having this conference; it has been
scheduled in June. It is on everybody s schedule and will be held at
that time. Now, if you ask me, could we have shortened that a
month, I am not going to sit here and say yes or no. I am sure that
we might have done that with 20/20 hindsight, but at the time we
moved in a reasonable fashion based on the knowledge that was
available.
Mr. Gore. Dr. Beary, does DOD ever conduct clinical trials?
Dr. Beary. We participate in cooperative trials with NIH. Our
large centers like Walter Reed, for instance, would likely have
clinical research projects going, fitting the description you are ap-
plying there.
Mr. Gore. If you consider this procedure experimental, have you
considered a clinical trial program encompassing the seven or so
children that need the procedure, covered by your plan?
Dr. Beary. Our transplantation expertise tends to be in bone
marrow and kidney areas. To my knowledge, we do not have people
579
who approach Dr. Najarian and Dr. Starzl in ability to deal with
the complex area of liver transplantation.
Mr. Gore. And you couldn't fashion a clinical trial involving a
population that received treatment from physicians other than mil-
itary doctors?
Dr. Beary. If the Committee would like me to do so, I can in-
quire as to what the possibilities are to pursue that.
Mr. Gore. Yes. If you could get back to us on that, it might be a
way to get this child an operation.
Congressman Volkmer?
Mr. Volkmer. I have no questions.
Mr. Gore. We have a vote on in the full committee. It is just
down the hall. I do have a few more questions, and I hate to strain
your patience and indulgence, but if you would permit us, we
would like to adjourn for just 5 minutes, and then we will come
back and finish up this panel.
[Short recess taken.]
Mr. Gore. The subcommittee will come back to order.
Without objection, I would like to put into the record a letter the
subcommittee has received from a Sergeant Frank W. Silcox, who
is stationed at Cecil Field. He is a Marine stationed in Jacksonville,
Florida, whose son is 18 months old, who needs a liver transplant.
He was told by CHAMPUS that the procedure was experimental.
He writes in his letter that he contacted The White House, and a
Mr. Batten at The White House wrote to Children's Hospital in
Pittsburgh stating that CHAMPUS should cover the operation.
That is a quote. Quoting further: "Now we are confused on wheth-
er the operation is covered or not covered."
[Material to be supplied follows:]
580
3306 treen Street
Jacksonville, PL
April 21, 1903
Rep. Albert Bore, Jr., Chairman
Subcommittee on Investigations and oversights
Committee on Science and Technology
822 House Annex #1
f .8. Souse of Representatives
Washington D.C. 20515
Dear Rep. tore
I am a career Marine stationed at Cecil Field, Jacksonville, Florida. I
hare a eon 18 months old in need of a liver transplant. As the operation
is not available at the Naval HoS' ital my son has been referred to
civilians at Children's Hospital , Pittsburgh, Pennsylvania. My major
problem now is the financial aspect of the surgery.
I have spoken to Mrs. Slover, the Champus representative at NAS Jacksonville.
She advised me that the surgery is considered experimental and not a covered
option under the Champus prograi. She suggested I contact the ChanpHS
offiee in Colorado. I spoke with Navy Lt. Miller in Colorado on April 8
or there about. He said Champus does not cover liver transplant surgery
or any hospital stay in regard to transplant surgery.
Since the surgery is costly, approximately $70,000 to $150,000 and I am
an active duty Marine with medical services provided by the government,
1 do not have any private hospital insurance program or ant other means
to pay for the surgery.
We have contacted Children's Hospital in Pittsburgh, Pennsylvania and have
thus contacted Michael latten, aide to President Reagan. Mr. latten wrote
to Children's Hospital stating that Chanpus should cover the operation.
Now we are confused on whether the operation is covered or not covered.
We have asked help and direction from our friend, Retired SeniorChief
John Clark III, and he has established a trust fund for our son through
the ireater Jacksonville Community Foundation. He is currently working
on procuring the necessary jet transportation and other fund-raising
driveB .
Attached is a copy of a letter I have written to President Reagan requesting
any help and assistance he can offer. Is there some way to revise the
current Champus program and help us help my son and all other servieemen
who may one day find themselves in similar dire straits?
Frank V. Silcox, Sgt. r
/
581
Mr. Gore. Have you been in contact, Dr. Beary, with the White
House about this matter?
Dr. Beary. No. Mr. Batten never called to discuss the matter
with me.
Mr. Gore. All right.
Dr. Brandt, you talked about the CDC pilot study on how to in-
crease donor awareness.
Dr. Brandt. Yes, sir.
Mr. Gore. First of all, just a technicality. I said in my statement
that it was a ninefold increase that the program produced, and you
took issue with that and said it was a threefold increase. Let me
just clear that up for the record.
In the base year, the year before the program went into effect,
there were 10 kidneys retrieved. Two years later, there were 88
kidneys retrieved; 3 years later, 90 kidneys retrieved. That appears
to be a ninefold increase.
Dr. Brandt. The information I have was that in the base year
there were 30 kidneys retrieved, and then it went to — I don't think
it is really — I mean, the facts are that it increased dramatically.
The information that I received from CDC indicated 30, then 88,
and so forth.
Mr. Gore. All right, fine. But it was a success, right?
Dr. Brandt. Yes, sir. It was a success; no question about it, for
kidneys. I would like to point out that whether or not that is appli-
cable to other organ systems is, at the moment, not known, in part
because with kidneys you do have an organ preservation time that
exceeds that of both liver and heart. It is clear that this system
worked. We have made that information widely available through
the transplantation literature and have provided technical assist-
ance and will provide technical assistance to any organ procure-
ment group that wishes to take advantage of that.
Mr. Gore. Yes. Well, I think the figures are complete enough in
the study to show that the longer survival time of excised kidneys
is not a sufficiently large variable to diminish the applicability of
the conclusions to other organs as well.
Why was this study terminated?
Dr. Brandt. Well, this study, which was done some years before
any of us at this table were around, was intended to be a demon-
stration. It was intended to demonstrate to the medical community
at large, steps that could be taken. When they had successfully
demonstrated the steps that could be done and made the informa-
tion widely available, it was then the goal that those organ pro-
curement groups that are currently in operation would pick up
those techniques and run with them.
Mr. Gore. Yes. The original plan was that if the pilot study was
a success, the CDC would move into five regional demonstration
projects. Everyone who has looked at these problems agrees that
donor awareness is the key to solving the problem. The problems of
financing will eventually be solved. They should be solved sooner
rather than later, and we have been talking about that. The effi-
ciency of the donor procurement network is important, but the key
to the problem is donor awareness, and here the CDC demonstrated
either a threefold or a ninefold increase in organ availability, and
they were going to expand it into five regional demonstration proj-
582
ects, and the demonstration projects alone were calculated to save
the ESRD program substantial sums of money.
And yet, Dr. Davis, HCFA declined to continue the demonstra-
tion projects. Why?
Dr. Davis. Well, as Dr. Brandt indicated, that study was complet-
ed and that request was asked of a different administration. I
really cannot second-guess what a previous administrator or the
previous administration felt in relationship to why they did not
wish to continue the demonstration projects.
Perhaps it was because there was a request for $3 million for five
sites. I simply do not know. When I first became involved in the
end-stage renal disease program in March 1981, I soon became
aware of the necessity for the Department as a whole to develop
what I thought was an overall strategy relative to all of the end-
stage renal disease program. Transplantation, prevention, and re-
search all needed to be considered. I asked one of my senior staff to
chair an interdepartmental task force that would look broadly at a
number of these issues That task force worked very diligently for a
number of months and brought forth a report in April 1982 which I
think both Dr. Brandt and I have found very helpful. We proceeded
to try to implement some of the suggestions as a result of that task
force and one of them has been, of course, the whole area of trans-
plantation.
Mr. Gore. Now, do you have an Office of Special Programs?
Dr. Davis. No, I do not. There was one.
Mr. Gore. Where is the Office of Special Programs making rec-
ommendations for supporting and fostering kidney transplanta-
tion?
Dr. Davis. There used to be an Office of Special Programs within
HCFA. That particular component was phased out and the individ-
uals were transferred into either the operations or the policy com-
ponents because I felt that it was important to have them function-
ing within the total system.
Mr. Gore. Well, Dr. Davis, in July 1981, the Office of Special
Programs made recommendations to you about fostering kidney
transplantation, and they revived the recommendation that the
CDC demonstration projects go forward, along with increased sup-
port of transplant coordinators.
That is not the last administration; that is this administration.
Dr. Davis. No. That was a recommendation to me, Mr. Gore.
Mr. Gore. That was a recommendation to you. Why did you fail
to take action on that recommendation?
Dr. Davis. Because, as I said earlier, I felt that it was important
to develop an overall departmental strategy and that there were
serious problems within the whole ESRD program that needed to
be looked at, not just transplantation alone. I felt that we deserved
to sit down as a department and look at a number of these areas
and develop a cohesive strategy of which transplantation would be
one part of it. So I wished to delay that particular component and
integrate the findings into the overall interdepartmental group.
That was done and the report was completed in April. As an out-
growth of that report, both Dr. Brandt and I have begun to imple-
ment some of the ideas from the interdepartmental group.
583
Mr. Gore. Well, in the meantime, what happens to the CDC dem-
onstration projects? They are put on the shelf?
Dr. Davis. The CDC demonstration project was completed, as Dr.
Brandt said.
Mr. Gore. No, no, that is the pilot study.
Dr. Davis. That is right.
Mr. Gore. The second phase was the one that was going to be the
five demonstration projects, which would not only increase donor
availability but also save the taxpayers money, and the estimates
are that it would have saved a great deal of the taxpayers' money.
You got a recommendation in July of 1981 that you go forward
with that. As I understand your testimony here, you are saying
that you have put it on the back burner to wait until some other
work on the kidney program gets done
Dr. Davis. As a total integrated strategy.
Mr. Gore [continuing]. And you may or may not include that in
with other recommendations.
Dr. Davis. No, sir. What I said was that we wanted to develop a
total integrated strategy for all of the activities as they relate to
the end-stage renal disease program. That is why we had the inter-
departmental task force. The outgrowth of that task force was the
report in April 1982 and, if you will recall, the September 16, 1982,
Federal Register notice which indicated that we had an interest as
part of our research program activities in studying kidney trans-
plantation as an alternative to lifetime dialysis. The notice stated
that we wanted to look at two things: first of all, an analysis of the
difference in the outcomes and the related factors in relationship
to kidney transplants by looking at demography and age and geog-
raphy and all of those things; and, secondly, as another factor, we
wanted to study the development and testing of systems that in-
cluded incentives to promote the availability of kidneys.
Mr. Gore. Yes.
Dr. Davis. So I think it does show that we do have an interest in
continuing innovation in this area.
Mr. Gore. Dr. Davis, let me try to ask the question in a little
different way. I am getting a little confused.
The recommendation for five regional demonstration projects,
what is the status of that recommendation?
Dr. Davis. That recommendation was made to the previous ad-
ministration, and that recommendation was not approved by
HCFA. I cannot answer the reason why.
Mr. Gore. No, no. Excuse me. That recommendation was in this
administration. It was originally in the previous administration in
March of 1979, a proposal for an expanded kidney procurement/ re-
trieval effort. But then in this administration, your Office of Spe-
cial Programs, before you abolished it, or before it was abolished — I
don't know who was responsible for that
Dr. Davis. I integrated the individuals into other parts of the
agency.
Mr. Gore. All right. Before they were integrated elsewhere, in
July of 1981, that Office of Special Programs recommended to you
that you go forward with the five demonstration projects to further
demonstrate the donor availability success as shown in the pilot
study and, at the same time, save the taxpayer's money.
584
What I am getting at is, what is the status of that recommenda-
tion which was made to you? Have you rejected it or accepted it or
what?
Dr. Davis. I held it in abeyance until we completed our work on
the overall departmental strategy.
Mr. Gore. Has that been completed?
Dr. Davis. The work on that
Mr. Gore. Has the overall strategy been completed?
Dr. Davis. Yes, sir, it has, and we are now
Mr. Gore. OK, well, now, has that recommendation remained in
abeyance?
Dr. Davis. Yes, it has remained in abeyance because I think that
there have been a number of new activities that have occurred in
the meantime, and I wish to update our knowledge as to whether
or not that same type of program and the $3 million that would
have been spent were appropriate in light of the new techniques
and knov/ledge that we have, or whether there are more effective
ways of public education.
Mr. Gore. How long do you anticipate it will remain in abey-
ance?
Dr. Davis. We expect to have the results from our new studies.
As I mentioned earlier, the Brandeis study has been looking at the
whole area of organ procurement, and I expect that its results will
be in within the next year.
Mr. Gore. Yes. He is testifying to us on a later panel.
Dr. Davis. Yes.
Mr. Gore. You also got a recommendation for the development of
a national transplant registry. Several other witnesses in our hear-
ings 2 weeks ago made a similar recommendation. Is that recom-
mendation also in abeyance?
Dr. Davis. The task force group, I believe, did consider that par-
ticular activity and determined that HCFA should take a lead re-
sponsibility in terms of acquiring the data that would be available
for all component parts of the end-stage renal disease program.
Mr. Gore. Are you going to
Dr. Davis. We are trying now to determine what is the appropri-
ate amount of money that we would be spending and how we would
develop the data collection component for the end-stage renal dis-
ease program.
Mr. Gore. So you do intend to establish a national transplant
registry?
Dr. Davis. No, sir. I am indicating that the broader strategy was
to collect data on all of the component parts of the end-stage renal
disease program.
Mr. Gore. Well, what about the recommendation that you devel-
op a national transplant registry? I don't mean to be too persistent
on this, but are you going to accept or reject that recommendation?
Dr. Davis. I cannot speak to that at this point in time because
that recommendation came out of an initial paper 2 years ago, and
we will have to take those things into consideration again.
As I indicated, it was part of the overall interdepartmental strat-
egy when we looked at it, but I do not recall a specific recommen-
dation that related to that.
585
Dr. Gore. Well, I do not mean to sound unkind, but the speed
with which you appear to be evaluating the recommendations on
how to enhance donor awareness seems to be equivalent to the
speed with which you are reevaluating the alleged experimental
nature of the transplant procedure.
In both cases, it is taking an unacceptably long amount of time,
and I just think that we could do a lot better.
Have you determined how you will allocate costs of organ pro-
curement under prospective payment procedures?
Dr. Davis. Well, as you know, the prospective payment procedure
does set a specific rate according to the DRG, and there will be a
DRG for transplantation, but it will be specifically on the kidney
transplantation. It is DRG-302.
In relationship to how we will pay for the organ procurement,
no. We have that under study at this point in time, because we do
not want to develop a system that would penalize or cause unneces-
sary deterrents to the organ procurement program. So I have to
make some decisions in the near future on that.
Mr. Gore. Did you stimulate this letter that was referred to in
the testimony 2 weeks ago alerting hospitals to potential problems
with their insurance coverage if organs other than kidneys were re-
moved from the same donor? Do you know the letter that I am re-
ferring to? It was mentioned several times in the testimony 2
weeks ago.
Dr. Davis. I believe the letter you are referring to is something
that the intermediary sent out as a point of clarification.
Mr. Gore. Aetna sent it out, and Aetna said that your agency
told them to do it.
Dr. Davis. Well, since we only pay for kidney transplants, then,
yes, I think it would be appropriate to say that the clarification
probably did come from our statement. Since we cannot, at this
point in time, pay for the non-kidney organ, transplantations be-
cause they are still experimental, then that would be an appropri-
ate assumption to make.
Mr. Gore. So what is a doctor supposed to do if he has a donor
and the parents say, "Look, we want to save as many lives as we
can as the result of this tragedy." In our moment of tragedy, we
recognize the opportunities, as Dr. Koop stated earlier — and this is
a key to the problem, families making this sort of decision.
Let's say the family makes that decision and they want to donate
a liver as well as the kidneys, and yet the doctor removing the
organs is advised that he may lose his insurance coverage if he re-
moves something in addition to the kidney. That is what the impli-
cation of the letter from Aetna was. Did you intend that?
Dr. Davis. No. Let me clarify what the intent is. The intent is
that the organ procurement costs will pay the full cost for the
kidney removal and/or a corneal removal. In effect, what that
means is that the cost for removal of an additional organ such as
the liver, heart, lung, or pancreas would be a marginal cost, and
those costs would be assumed elsewhere.
But, in effect, as you can see from chart 4, a large number of
organ procurement centers do get full-cost reimbursement for the
kidneys. I think you will find that a large amount of the cost for
586
that particular agency is borne under the medicare program with
respect to the kidney transplant costs.
Mr. Gore. Congressman Skeen?
Mr. Skeen. I have one last question.
Dr. Brandt, what is the status now on cyclosporin as far as an
approval? It has not had FDA approval?
Dr. Brandt. That is correct; it does not have FDA approval.
There are still some technical aspects of it with its manufacture
and that sort of thing that are being reviewed by the FDA. It is
always hard to preclude, but a decision will be made soon.
Mr. Skeen. At what point, then, do you decide whether or not it
is a drug for which you can make reimbursement?
Dr. Brandt. As soon as FDA approves it, it will
Mr. Skeen. Thank you, Mr. Chairman.
Mr. Gore. Dr. Koop, you indicated that President and Mrs.
Reagan have requested your assistance in helping families and
children who need liver transplants. Can you share with us the
number of families with whom you have interceded?
Dr. Koop. I suspect probably five. My role in that has been to
counsel the family, in some instances; to talk to organ procurement
people in the same city; to talk to the surgeon, giving him some
encouragement and some advice on where to go.
While I am saying that, sir, I would like to make one thing clear.
You and we are on the same side. The only thing we differ on is
speed.
Mr. Gore. Thank you.
Dr. Koop. I think, if you look at what we have done, it is not
quite as bad as it has been painted to be. It was the Public Health
Service that invited the Children's Liver Foundation and Dr. Starzl
here to start talking about this.
Out of that came the conference Dr. Brandt referred to, where it
was decided with international experts we did not have the ability
to say that this is not experimental. Then the consensus conference
was set up.
When you consider the expertise and the capacity of the people
coming to this consensus conference, to set it up in a year is not a
long time. But then, as we saw what might happen from the con-
sensus conference, we stepped in through my office and organized
this organ procurement workshop.
We get as frustrated with slowness as you do, but I would just
like you to know that our intention is right, our heart is in the
right place, and we will speed it up as fast as we can.
Mr. Gore. Well, I appreciate that statement, Dr. Koop, and I
hope you understand the frustration that we feel here on this sub-
committee, because we have had testimony from mothers and fa-
thers with children in the room who will live or die depending
upon whether they get the procedures in question.
In all too many cases, they have been told that they cannot save
the lives of their children unless they can get the money to pay for
the operation.
Then we have had testimony from doctors who have described
the dramatic successes now occurring with this procedure.
587
And then to encounter, I guess, any slowness on the part of the
Federal bureaucracy is really very frustrating, but I appreciate
your statement very much.
Mr. Skeen. Will the chairman yield?
Mr. Gore. Yes, I will be glad to yield.
Mr. Skeen. I thank the chairman.
I think, too, that it points out what has happened to us, and
thank goodness it does progress in this manner, that the technol-
ogy progresses more rapidly than the regulatory groups and the
legislative bodies do, and we are glad for that rapid progress.
If we can find some way, together, that we can speed up the ad-
ministrative process, this subcommittee will do whatever it can.
Mr. Gore. Incidentally, Dr. Beary, CHAMPUS did pay for liver
transplants in the past, didn't they?
Dr. Beary. If they did that was probably in the pre-1975 era
when the CHAMPUS administration was changed. Possibly that
would explain the situation.
Mr. Gore. Yes. CHAMPUS used to pay for them, and I believe it
was in that period, when the results were not nearly as good as
they are now.
Mr. Volkmer. Mr. Chairman?
Mr. Gore. Yes, Mr. Volkmer?
Mr. Volkmer. I would just like to ask a general question. Maybe
it has been covered before. But can we envision that in the future
we will have a registry for transplant organs, an availability infor-
mation type system?
Dr. Brandt. At the present time, sir, there is a national system
for kidneys. It is run by the Southeastern Organ Procurement
Foundation as a private sector function. I am unaware at the
present time of any other system.
However, at the conference to be held in June, certainly that will
be one of the issues that will be brought up.
We also have the North American Transplant Coordinators Or-
ganization, which has a 24-hour alert communications system used
by medical professionals concerned with transplantation. In the 6-
month period from September 1982 to March 1983, they found
matched recipients and donors for 28 hearts, 44 livers, and one
heart and lung.
So there are two systems operational right at the moment. Now,
whether or not they should be both private sector operations as
they are clearly, any deficiencies will be explored, I am sure, at
the Conference on Organ Procurement.
Mr. Volkmer. These are private foundations at the present time?
Dr. Brandt. Yes, sir, that is correct.
Mr. Volkmer. Can you tell me how they are funded?
Dr. Brandt. I do not know, but I will find out and supply that
information to you for the record.
Mr. Volkmer. I would like to know that.
[Material to be provided follows:]
The cost of registries that cover kidneys, such as the Southeastern Organ Procure-
ment Foundation, are considered to be kidney acquisition costs and are funded
under Medicare, Part A. Registries for extra-renal organs which are not reimbursed
by Medicare are funded primarily through patient billing. An example of this would
be the registry of the North American Transplant Coordinators Organization.
588
Dr. Koop. It also should be said, sir, there is a whole new breed
of health professional arising on the scene. Instead of just being
organ procurement people, these are organ donation people.
For example, two hospitals here in Washington jointly employ a
young physician whose job it is to talk to the families of youngsters
who are about to die, to compassionately get across the things I
have been trying to say this morning. Then she begins to inquire,
in an ever-enlarging circle around Washington, where there might
be a suitable recipient.
So you have people looking for organs and people trying to give
them away. I think that after we get all of these people together at
the Surgeon General's conference in June, we could have a much
more efficient national or regional program.
Mr. Volkmer. Thank you.
Mr. Gore. Dr. Koop, I wish to congratulate you on your June 7,
8, and 9 Conference on Organ Procurement, and the subcommittee
staff will be taking part in that and has already been in contact
with you and your staff, and I hope that we can work together to
develop a national strategy for greatly increasing the awareness of
the need for organ donation.
We are indeed on the same side in that effort, and it really needs
to be done. I hope that out of that may come some stimulus to go
back and look again at this CDC demonstration project proposal.
We should not just automatically reject things because they came
out of another administration. I am not saying that was done in
this case, but the studies supporting this proposal are so impres-
sive.
We look forward to working with you on that. I would like to
thank all of our witnesses on this first panel for appearing here
today. Thank you very much.
We have an addition to the witness list. Before Dr. Banta comes
forward, Senator Dale Bumpers of Arkansas has asked to join in
this effort, and we know of his long efforts in this field, and we
would be privileged to hear from him at this time.
Senator Bumpers, we are mighty pleased to have you here today.
Thank you for your special interest in this field. Please proceed.
STATEMENT OF HON. DALE BUMPERS, A U.S. SENATOR FROM
THE STATE OF ARKANSAS
Senator Bumpers. Mr. Chairman, first of all, let me thank you
for two things: No. 1, your untiring devotion to the cause for which
you are holding these hearings; and, No. 2, for allowing me to come
in.
I will be very brief. I do not have a prepared statement. The
reason I requested permission to come here is that I share your in-
tense feeling about the necessity of doing something. We know
what we want to accomplish, but nobody is certain just yet how to
go about it.
But I would simply like to say that one of the reasons I am so
concerned is that my interest in this issue was piqued when I was
Governor of my State, because the medical center in Arkansas was,
I believe, one of the first medical centers in the country to perform
589
a kidney transplant. We have had an ongoing program there that
has been extremely good.
I do not know which ones are the best now. I know that the Uni-
versity of Alabama has a very good program. As you know, the
kidney transplant program is perhaps the oldest, and they have the
best regional setup right now for matching donors and donees.
It certainly would be good for all of us to talk to these people in
depth about how they have gone about it and avoid some of the
mistakes that perhaps they have made along the way.
I do not want to bore the committee with duplicating statistics
that I know you have heard, but I might say one other thing. There
is another very good reason, and that is that it's tragic that people
are so desperate that they are calling on us as Members of Con-
gress to help them.
Yesterday, we got a call in our office from the Montefiore Medi-
cal Center in New York. There is a 60-year-old retired Air Force
colonel there who is awaiting a lung transplant. My guess is that
most people, and maybe some in the medical profession, do not
know that lung transplants can be done, because this surgery is in
its embryonic stage. But Colonel Bell is suffering from a disease
known as fibrosing alveolitis. Finding a donor for him is getting to
a very desperate and critical point. I issue an appeal for help with
this search for a donor.
Some might not be aware of the fact that the Montefiore Medical
Center in New York does these transplants. There have only been,
I think, 10 or 11 lung transplants done, and there has only been
one since the development of cyclosporin A. While this surgery is
still in its experimental stage, this drug does offer considerable
promise in the field.
The one person on whom a lung transplant was performed since
this new drug was developed was a Vietnam war veteran. He had
paraquat lung damage and unfortunately did not survive. Even
though he was the one who has received the new drug, his body
was so damaged the surgery could not be successful. In the case of
Colonel Bell, all of his other organs are healthy, and he would have
a good chance of responding well to the surgery if a donor could be
found in the next 2 weeks.
The other thing I want to point out is that we have a bank simi-
lar to the kind some of us have been thinking about in this field.
This is a bank set up nationwide for missing children. You have
been here since that was developed. We all voted for the funding of
that.
It is my understanding, for example, that a kidney is good for 72
hours, a liver is good for about 12 hours, heart and lungs are good
for about 4 or 5 hours. If you just look at those times, you might
conclude that perhaps the only sensible thing to do is a regional
bank, simply because of the time. If somebody dies in San Francis-
co, you will not have time to excise the organ if it is a heart, for
example, and fly it to Miami.
But it seems to me that this would not be a detraction from a
national computer bank system. In this kind of technological age, it
seems to me foolish that we don't have a national computer system
to match donors and donees almost immediately.
23-029 0-83-38
590
The other big problem — and I know you have talked about this
today — is that perhaps our police have not been trained well to
look for the donor card on the bodies of victims of automobile acci-
dents.
In Arkansas, as well as in about two-thirds of the States of this
country, we have a notice of willingness to be a donor on our driv-
er's licenses. This committee would have better information on that
than I do. But I think the information on the backs of driver's li-
censes could be improved somewhat. We are not going to impose on
the States some kind of standard for their driver's licenses, I
assume, but if that were national, if there were some kind of a uni-
form donor system notice on the backs of driver's licenses, it would
not take 24 hours to tell every policeman, every State trooper in
the country, where to look immediately for this kind of informa-
tion.
I have some statistics here which, incidentally, were really inter-
esting to me. In my State, we have 50 people waiting for kidney
transplants, and about 30 people on a cornea transplant list. Last
year in the Nation, there were 4,800 kidney transplants, but there
are 5,000 people now on dialysis, waiting for a kidney.
We are doing about 100 heart transplants a year. Here is the
real raison d'etre for this hearing: 20,000 people are going to die
this year of head injuries or some other trauma that would leave
their organs extremely acceptable; and yet only a small percentage
of those people's organs will be used.
Of all the people who die in hospitals every year, it is estimated
that only 2 percent of them would be suitable donors, and of that
number, less than one-fifth are being used.
So, if you look at those statistics, it is quite obvious that if we
really made a monumental effort as we should, if all the people
dying in hospitals were donating their organs and they were being
used, we would probably have a donor for just about everybody
that is on the waiting list.
Mr. Chairman, that just about sums up everything I wanted to
say on this. I admit it probably does not add a lot to the edification
of the committee, but I wanted to be on record expressing my very
strong support for what you are trying to do here.
Mr. Gore. It adds a great deal, and your active help on this issue
will add a great deal more, too, and we will work together on this.
Congressman Skeen has had some ideas on the nationwide com-
puter bank similar to the ones you have just expressed.
Do you have any questions?
Mr. Skeen. Thank you, Senator. I think you have contributed a
great deal. We appreciate your being here today. It is this kind of
interest that I think emphasizes what we are trying to do here, and
that is to provide for a kind of public awareness of just what we
are losing.
When you give us the numbers that you have right now, that
with all the people on dialysis, they would have a kidney within
this year if there were a suitable donor program initiated or some
informational system in effect that could match up those people
with their kidneys, and the donors were willing. I think that you
have made a very significant contribution to it, and I thank you.
591
Senator Bumpers. Congressman Skeen, if I could just say one
other thing, I started out by pointing out that the monumental pro-
portions of the tragedy are best illustrated by the fact that so many
people call me, perhaps call you, desperate for national publicity to
try to find a donor, as in the case of Colonel Bell, whom I have just
described.
It is very difficult for me to say to Colonel Bell, yes, I will do my
very best to help you. This is not the job of politicians, though, and
when I realize how many people in this country are waiting for
transplants, you know, in a sense you feel uncomfortable, but you
cannot ever deny anybody the right to try to find an organ.
One of the really good effects of that is — both in what I am
saying about Colonel Bell and what this committee did for the
Nation the other day in the liver transplant case for the child in
Memphis— those are the kinds of things that have probably done
more to raise the awareness level than anything else we could have
done.
Mr. Skeen. I share your concern, too, because using the media as
a method, or politicians, if you will, either one, makes you some-
times wonder about the justice of this. What about the person who
does not have that kind of access and that you are jumping one
case over some others?
Senator Bumpers. Exactly. We all feel a little uncomfortable
with that.
Mr. Skeen. It makes me very uncomfortable, and I am sure it
does everyone else.
But I thank you, Senator, for your personal contribution.
Senator Bumpers. Thank you, Congressman.
Mr. Gore. I might announce that at the beginning of the hear-
ing, I talked about the two children in Memphis, Brandon Hall,
who is doing much better. I said that Jerry Harrison was still
awaiting a liver. We just received word that he died this morning
at the LeBonner Hospital in Memphis; 6 years old, from Indianapo-
lis, died of irreversible liver failure. He was number one on the list
and awaiting a transplant at the time.
Senator, thank you very much.
Senator Bumpers. Thank you, Congressman Gore and members
of the committee, for inviting me over here.
Mr. Gore. We will talk later, too, about things that we can do
together in the future on this. Thank you so much.
Senator Bumpers. Thank you.
Mr. Gore. Our next witness is Dr. H. David Banta, Assistant Di-
rector of the Health and Life Sciences Division with the Office of
Technology Assessment here in Washington.
Dr. Banta, we are delighted to have you here. We are cognizant
of the fine work you have done in this area, and we are most eager
to hear your testimony.
Please proceed.
STATEMENT OF H. DAVID BANTA, M.D., ASSISTANT DIRECTOR
FOR HEALTH AND LIFE SCIENCES, OFFICE OF TECHNOLOGY
ASSESSMENT
Dr. Banta. Thank you very much, Mr. Chairman and Mr. Skeen.
592
I am pleased to appear before you today to discuss issues of
human organ transplantation and medical technology assessment.
OTA has conducted a few specific studies of organ transplanta-
tion and artificial organs; for example, end-stage renal disease and
the artificial heart. Although my remarks will draw upon that
work, they will be most heavily based on OTA's extensive work on
the importance and status of medical technology assessment and
on techniques and systems for conducting assessments.
Organ transplantation, as you have heard, is clearly a dramatic
area of medical science and technology. Advances in human organ
transplantation are proceeding at an often rapid but sometimes
frustratingly slow pace. Many applications are still considered ex-
perimental, as you very well know by this time; for example, by
third party payers such as medicare and private insurance compa-
nies.
The testimony today from the representatives of HHS has cov-
ered the status of each transplant with regard to payment, and
those statements are accurate, so I will not go into that any further
at this time.
The question of experimental status is a difficult one but most
likely needs to be reexamined for the various forms of transplanta-
tion due to recent advances in biomedical science, as you have also
heard.
Now let me make a few comments about resource allocation. Re-
source allocation is, in essence, in our view, a political activity and
responsibility; yet it can be informed by relevant information de-
rived from analysis and assessment.
Organ transplantation is an area where the allocation of scarce
resources demands both quantitative and qualitative data, and
where social and political factors will always play by far the larg-
est determining role.
Today we are most concerned with the allocation of resources
within the area of health and health care. Even so, there is an
entire series of possible ways to spend money. Few areas of medical
technology point out so dramatically the tough nature of the
choices to be made in allocating resources as does organ transplan-
tation.
Consider, for example, basic research; evaluation of technology's
benefits, risks, and costs; development and funding of delivery and
distribution systems; health services research to improve those sys-
tems; disease prevention, screening, health promotion, and so forth;
and many other possibilities.
Like it or not, when we choose to spend a certain amount of
funds on any particular one of these categories, we are denying it
to others.
Medical technology assessment, whether of health benefits and
risks or of costs or of social implications, can provide decision-
makers with more information on which to make their decisions. It
can help in showing what is known. It can point out uncertainties
and assumptions. And it can sometimes help draw the dividing line
between what can be decided on the basis of research evidence and
what must be decided in the social or political arena.
The Federal Government has two important roles in medical
technology assessment, in my view. One is the broad function of
593
protecting the public health and promoting the general welfare.
Funding of biomedical research and general medical technology as-
sessment activities fall under this responsibility.
The Federal Government also has a specific role in the medicare
program to assure that all reasonable and necessary care— and
that is the language of the statute— is available to beneficiaries.
In both cases, the central task of technology assessment is to
assure two goals: first, that technologies provided to the public be
known to be efficacious and safe; and, two, that all technologies
known to be efficacious and safe are broadly available.
In OTA's September 1982 report, "Strategies for Medical Tech-
nology Assessment," we found the Federal Government's activities
to be inadequate in a number of areas. Only drugs and devices, as
was stated this morning, are examined in a systematic way as part
of the activities of the Food and Drug Administration.
Mr. Gore. Excuse me. You are on page 11 at the bottom now?
Dr. Banta. Yes, sir.
Mr. Gore. Thank you. Go ahead.
Dr. Banta. The Congress addressed these problems in 1978 in
passing legislation to establish the National Center for Health Care
Technology, NCHCT, but administration budget cuts led to
NCHCT's dissolution in 1981.
Although a remnant of NCHCT, the Office of Health Technology
Assessment, OHTA, which you heard referred to this morning, still
handles medicare coverage decisions for the Public Health Service,
many problems remain unaddressed. There is in fact no systematic
identification of medical and surgical procedures needing assess-
ment. Investments in testing, such as clinical trials, are small rela-
tive to the needs for information. Synthesis and summary activities
are generally undeveloped, and dissemination of results has actual-
ly been cut back in the past few years.
The Government's activities concerning the medicare program il-
lustrate some of these problems. Medicare has interpreted its man-
date to provide medically necessary services as requiring it to ask
three questions before a new technology is covered:
First, is the procedure safe? Second, is the procedure effective?
Third, does the procedure have the acceptance of the medical com-
munity?
I might note that the term "reasonable and necessary has never
been defined in regulations.
Until late 1979, the procedure for making these coverage deter-
minations was highly informal. OTA criticized this process in its
1978 report on computed tomography— CT— scanning. In 1978, Con-
gress addressed the problem in mandating NCHCT review of medi-
care coverage decisions as part of that agency's responsibilities.
Since 1981, when NCHCT disappeared, the OHTA has operated
at a lower level of effort than the NCHCT did. This is clearly illus-
trated by the fact that the issue of liver transplant, which was
found experimental because of lack of data in 1980, has not been
reexamined, despite the accumulating evidence, and you have
heard plenty of mention of that this morning.
While I strongly support the attempts to assure that new proce-
dures are efficacious, I also believe that it is very important that
decisions not to cover new technology must be reexamined at fre-
594
quent intervals in rapidly moving fields of medicine, and especially
when the procedures may be lifesaving.
Perhaps the most distressing case is that of heart transplant.
The NCHCT recommended that it be covered at selected centers in
February 1980. It is still not covered. The rationale was that heart
transplant raises many ethical and economic questions, as well as
efficacy and safety questions that are being addressed in the Bat-
telle study.
The previous Secretary of HHS, Patricia Harris, decided that
heart transplants should not be covered. However, I should note
that HCFA does not have the authority to base payment decisions
on such broader considerations as cost and ethical considerations.
Under HCFA guidelines, I believe heart transplants should be pro-
vided already.
I am sympathetic with the administration's concerns about
transplants. However, technology must be addressed in a consistent
manner. If HCFA lacks the authority to limit transplants to cer-
tain centers, it could request that authority. If HCFA wishes the
authority to base decisions on economic and social criteria, it can
request Congress to give it that authority. And, by all means,
HCFA should define "reasonable and necessary" by regulation.
One is left with the impression, in the case of heart transplant,
at least, that HCFA is delaying payment for cost containment rea-
sons. If this is a true perception, this is a serious perversion of the
process of technology assessment and its place in policymaking.
In summary, I see many problems in the Federal Government's
activities in medical technology assessment, both with regard to
the general society and with regard to the medicare program.
Thank you, Mr. Chairman. I did summarize my testimony, and I
would appreciate it if the entire text were put into the record.
I would be happy to address any questions.
Mr. Gore. Without objection, it will be.
[The prepared statement of Dr. Banta follows:]
595
STATEMENT OF
H. DAVID BANTA, M.D.
ASSISTANT DIRECTOR
FOR HEALTH AND LIFE SCIENCES
OFFICE OF TECHNOLOGY ASSESSMENT
CONGRESS OF THE UNITED STATES
Mr. Chairman and Members of the Subcommittee:
I am Dr. David Banta, the Assistant Director for Health and
Life Sciences, Office of Technology Assessment. I am pleased to
appear before you today to discuss issues of human organ trans-
plantation and medical technology assessment.
The Office of Technology Assessment (OTA) has conducted a
few specific studies of organ transplantation and artificial
organs (e.g., end-stage renal disease, the artificial heart).
Although my remarks will draw upon that work, they will be most
heavily based on OTA's extensive work on the importance and
status of medical technology assessment and on techniques and
systems for conducting assessments.
Because of this background, I will take a broad perspective
in my comments. After presenting some brief material on human
organ transplantation and on the types of questions or issues
raised by transplantation, I shall discuss resource allocation
and then cover the role and the potential contribution of med-
ical technology assessment.
ORGAN TRANSPLANTATION
Organ transplantation is clearly a dramatic area of medical
science and technology. Advances in human organ transplantation
are proceeding at an often rapid but sometimes f ru s t r a t ing ly
slow pace. Many applications are still considered experimental,
596
e.g., by third party payers such as Medicare and private health
insurance companies. Heart transplantation, as you know, is not
presently covered by Medicare, pending the results of a major
evaluation of its efficacy and safety. Pancreas transplantation
is not covered, although it is presently under review by the
Public Health Service. Liver transplantation is also not
covered based on a 1980 assessment by the Public Health Service
that found the procedure to be experimental. The issue of
whether liver transplants are to be considered experimental and
thus not paid for has been reopened. Liver transplants will be
the subject of a National Institutes of Health Consensus
Development Conference in June. The Fublic Health Service will
reassess liver transplantation following that Conference.
Cornea transplants are becoming more common and the procedure is
covered by Medicare on a routine basis. And of course, kidney
transplants have long been considered an established treatment,
and a special program under Medicare covers them.
The question of "experimental" status is a difficult one,
but most likely needs to be re-examined for the various forms of
transplantation, due to recent advances in biomedical science.
For example, it appears that improved success rates are occur-
ring because of Cyclosporin A, improvements in pre transplant
blood transfusion matching and techniques, and increases in
surgeons1 experience. This does not necessarily mean that all
transplantation has moved beyond experimental status, nor does
it eliminate the need to consider a large set of questions that
go beyond clinical risks and benefits when making decisions
about transplantation.
597
ISSUES RAISED BY TRANSPLANTATION
Whatever their status is, and whatever the pace of advance
is, however, each form of organ transplantation raises questions
that need to be examined. Some questions are personal ones,, to
be faced by individuals. Others are for society and its insti-
tutions. Many must be considered by the Federal government, and
thus are of special interest to these hearings. A sample of the
questions raised follows.
1. Research and Development Questions. Are we focusing
on the most appropriate research areas? Are funding
levels adequate? What is the balance between basic
research, applied research, and technology development
for any particular medical technology? Is this the
best use of scarce research dollars?
2. Efficacy and Safety Questions. What types of eval-
uation of current and potential effects have been done
or need to be conducted? What are the medical tech-
nology's impacts on health (clinical benefit and risk)
both in the short term (e.g., successful transplant
rates, operative • mortality, complications, graft
rejection) and in the longer term (e.g., long term
survival, quality of life enhancements over time)?
Who will ask the assessment questions; who will
attempt to answer them; and who will act based on the
answers? Are data adequate?
3. Adoption, Financing, and Use Questions. Is the rate
of adoption (initial entry of the technology into use)
and then use appropriate? Are the populations most
likely to benefit from the technology receiving its
benefits, or is access skewed? Who will pay for the
use of the technology? Are delivery systems inade-
quately or inefficiently organized? Donor identifi-
cation and organ distribution are crucial issues here.
4. Regulatory Questions. What regulatory oversight is
applicable to the transplantation technologies? For
example, what is the role of the Food and Drug Admin-
istration? What other Federal or State programs
apply? What are or will be the effects of such
r egula tion?
598
Ethical, Legal, and Other Social Questions. Organ
transplantation raises many sensitive issues of
ethics, the law, psychology, religion, resource allo-
cation, and so on. What social questions need to be
asked in regard to the technology? Can they be raised
in advance of the technology's diffusion? Can assess-
ment provide helpful information? Who is responsible
for making decisions relative to an organ transplan-
tation technology's development, regulation, or use?
And can they make such decisions taking into account
the potential ethical and other social implications of
the technology? Equity is a particularly important
question in this area.
Econoaic and Cost Issues. Economic questions bring
together many points raised above: Is a particular
form of organ transplantation a "cost-effective" way
to expend resources? Are financing schemes and deliv-
Such a list of questions appears formidable, even though it
represents only a sample of the questions raised by any medical
technology. Nevertheless, they must be asked. Organ, trans-
plantation is too important for its development and use to
proceed without full knowledge of goals and possible impacts on
individuals and on society.
In the list above, many of the issues directly of concern
to the Federal government are obvious: funds and priorities for
basic and applied research" and technology development; dissem-
ination and development of data about organ transplantation and
its benefits, risks, and costs; financing of treatment; helping
to assure access and equity; and regulation.
599
RESOURCE ALLOCATION
Resource allocation is In essence a political activity and
responsibility, yet it can be informed by relevant information
derived from analysis. Organ transplantation is an area where
the allocation of scarce resources demands both quantitative and
qualitative data and where social and political factors will
always play by far the largest determining role.
One logical starting point that is often ignored or assumed
away is the split between the amount of resources to be spent on
health and on medical care as opposed to that allocated to all
other sectors of society. 1 In the past, this choice has often
been made in effect by ignoring it. This is changing, however,
as society begins asking how much health care it can afford and
who shall pay for it.
Today, however, we are more directly concerned with the
allocation of resources within the area of health and health
care. Even so, there is an entire series of possible ways to
spend money. Few areas of medical technology point out so
dramatically the tough nature of the choices to be made in
allocating resources as does organ transplantation.
1 Even this basic choice is not at all clear. For example, the effects of
environmental quality, urban security, housing, and so on may be quite
dramatic in terms of health.
600
Consider the following list of ways to spend funds on organ
transplantation and its alternatives for the related diseases.
Funds must be or could be distributed among:
o
o
Bas ic research;
Applied research and technology development;
Evaluation of technologies' benefits, risks, costs;
Development and funding of delivery and distribution
s y s t ems ;
Health services research to improve delivery systems
and financing of treatment;
Development and operation of communications/data
handling systems and creating and disseminating data
on the technologies, delivery systems, individuals in
need, and potential donors;
Disease prevention (e.g., screening, health promo-
tion) ;
Treatment of disease through organ transplantation;
Treatment of disease through artificial organs or
through other alternatives to transplantation;
Efforts to increase public understanding of
transplantation and organ donation; and
Many more possible ways to spend funds.
Like it or not, when we choose to spend a certain amount of
funds on any particular one of these categories, we are denying
it to others - perhaps not directly, perhaps not explicitly.
When we choose among these possibilities, we are making judg-
ments about their relative values as "investments" of our scarce
dollars, even though these judgments may be implicit or hidden.
Specific relative spending patterns reflect judgments on the
601
value of "health," on the value of extending life, on the value
of enhancing quality of life, on the value of reducing expend-
itures (of making cost-beneficial decisions), and on the value
of our image (of ourselves as individuals or as members of a
human society), and many others (such as the value of being a
research oriented people).
The critical problem arises when decisions that reflect a
high value placed on positive economic outcomes are different
from those that place a high value on other outcomes (equity,
quality of life, humaneness). The decisions will not always be
at odds. Investment in basic research is considered by many
people to be a sound financial investment. But they will differ
in many or most cases. The result is that we can not do all the
things that we would like to do as members of a caring society.
This split between economic goals and health or human goals
becomes especially acute in a field such as organ transplanta-
tion because transplantation is a prime example of what Dr.
Lewis Thomas has called "halfway technologies." Halfway tech-
nologies are not cures, they do not eliminate the cause of
disease. He does not term them "high technology" because they
are in some important senses crude attempts to make up for the
disease or condition. And, like most halfway technologies,
organ transplants are expensive and raise great issues of
resource allocation and moral and social dilemmas.
This clash between resources and medical and social goals
is one major reason why resource allocation, especially in the
area of organ transplantation, is and needs to be in large part
602
a social responsibility. As I will briefly mention below,
choices can be helped by formal analysis and data, but - the
fact will always remain - analysis of costs and benefits will
not tell us how to spend our resources. No cost-effectiveness
or cost-benefit calculus can usurp the position of social and
political decision makers.
MEDICAL TECHNOLOGY ASSESSMENT AND ORGAN TRANSPLANTATION
Medical technology assessment - whether of health benefits
and risks, or of costs, or of social implications - can at the
most provide decision makers with more information on which to
make their decisions. It can help in showing what is known; it
can point out uncertainties and assumptions; and it can some-
times help draw the dividing line between what can be decided on
the basis of research evidence and what must be decided in the
social or political arena.
In order to make the best decisions possible, society's
decision makers must have the best information that is available
or can be developed. Medical technology assessment can be of
particular help In providing the following types of information.
Some will be relatively direct and quantitative; other types
will be less definitive and more qualitative.
o
o
Data on a transplant technology's efficacy (its clin-
ical benefits) in terms of health outcomes (mortality
reduction, quality of life changes, etc.);
Data on both short term and long term risks of the
t echnology ;
Some measure of the costs of applying the technology,
both relative to alternatives to transplantation and
in terms of the potential aggregate cost to society
and the specific costs to individuals;
603
o Information on the structure and operation of the
systems for delivering the transplant technology and
the systems for gathering and preparing organs;
0 Information on disease prevention and health promotion
as alternatives to treatment (through both transplan-
tation and other forms of treatment) - especially
information on benefits, risks, and costs relative to
trea tmen t ;
o Primarily qualitative information on potential social
and ethical implications of transplantation or lack of
transplantation (including lack of financing or
access) ;
o
o
Estimates of fruitful areas of basic research and
applied research and technology development in which
to invest funds; and
Ideally, some characterization or practical estimates
of the near term future of dise-ase patterns, popula-
tion changes, technological advances, and social
institutions changes.
These types of information may help to make decisions moire
rational. They will rarely if ever point to a particular
decision (other than a clinical one on occasion). Some of the
needed information exists, but much more is needed.
We should face our ignorance. Decisions related to trans-:
plants are tricky and there are many gaps in our knowledge. At
the same time, developing and disseminating information is not
an inexpensive task. We can not develop all the possible infor-
mation about every type of transplant technology. Compromises
and judgments about the most helpful data will have to be
made .
EXECUTIVE BRANCH ACTIVITIES IN MEDICAL TECHNOLOGY ASSESSMENT
The Federal government has two important roles in medical
technology assessment. One is the broad function of protecting
the public health and promoting the general welfare. Funding of
biomedical research and general medical technology assessment
activities fall under this responsibility. The Federal govern-
604
merit also has a specific role in the Medicare program to assure'
that all reasonable and necessary care is available to benefic-
iaries. In both cases, the central task of technology assess-
ment is to assure two goals: 1) that technologies provided to
the public be known to be efficacious and safe; and 2) that all
technologies known to be efficacious and safe are broadly
available.
In examining the Federal government's activities in medical
technology assessment, OTA has used a simple model of
information development and flow:
Identification - Monitoring technologies, determining
which need to be studied, and deciding which to study.
Testing
trials .
Conducting the appropriate analyses or
Synthes-is - Collecting and interpreting existing
information and the results of the testing stage, and,
usually, making recommendations or judgments about
appropriate use.
Dissemination - Providing the synthesis of
information, or any other relevant information, to the
appropriate parties who use medical technologies or
make decisions about their use.
In our September 1982 report, Strategies for Medical Tech-
nology Assessment, we found the Federal governments activities
to be inadequate in a number of areas. Only drugs and devices
are examined in a systematic way as part of the activities of
the Food and Drug Administration. The Congress addressed these
problems in 1978 in passing legislation to establish the
National Center for Health Care Technology (NCHCT), but Admin-
istration budget cuts led to NCHCT's dissolution in 1981.
605
Although a remnant of NCHCT, the Office of Health Technology
Assessment (OHTA), still handles Medicare coverage decisions for
Public Health Service, many problems remain unaddressed. There
is in fact no systematic identification of medical and surgical
procedures needing assessment. Investments in testing, such as
clinical trials, are small relative to the needs for infor-
mation. Synthesis activities are generally underdeveloped. And
dissemination of results has actually been cut back in the past
few years.
But perhaps the greatest problem is the lack of a
systematic approach to the general problem of medical technology
assessment. Such activities as there are function with little
relation to each other.
The government's activities concerning the Medicare program
illustrate some of these problems. Medicare has interpreted its
mandate to provide medically necessary services as requiring it
to ask three questions before a new technology is covered: 1) is
the procedure safe? 2) is the procedure effective? 3) does the
procedure have the acceptance of the' medical community? Until
late 1979, the procedure for making these coverage determin-
ations was highly informal. A small staff would review the
issue, consult experts in the field with whom they were
acquainted, and come to a decision. OTA criticized this process
in its 1978 report on computed tomography (CT) scanning. In
1978, Congress addressed the problem in mandating NCHCT review
of Medicare coverage decisions as part of that agency's respon-
sibilities. In December 1980, the Health Care Financing Admin-
istration and the NCHCT signed a memorandum of understanding
23-029 0-83-39
606
formally setting-out the process for initiating and transmitting
NCHCT assessments. At the time NCHCT began operations, there
was a backlog of 58 requests from HCFA for coverage advice.
NCHCT developed an excellent staff and a credible process of
review in its two years of functioning and eau*ht up with the
backlog.
Since 1981, the OHTA has operated at a lower level of
effort. This is clearly illustrated by the fact that the issue
of liver transplant, which was found experimental because of the
lack of data in 1980, has not been re-examined, despite the
accumulating evidence. While I strongly support the attempts to
assure that new procedures are efficacious, I also believe that
it is very important that decisions not to cover new technology
must be re-examined at frequent intervals in rapidly moving
fields of medicine.
Perhaps the most distressing case is that of heart trans-
plant. The NCHCT recommended that it be covered at selected
centers in February 1980. It is still not covered. The
rationale is that heart transplant raises many ethical and
economic questions that are being addressed in the Batelle
study. However, HCFA does not have, and has not requested, the
authority to base payment decisions on such broader consider-
ations. Under HCFA guidelines, heart transplant should be
provided already.
607
Mr. Gore. You make some very strong statements in your testi-
mony. First of all, you say that the Federal Government's efforts
are inadequate in a number of areas. You say that many problems
remain unaddressed, that the investment in testing relative to the
need for information is very small; synthesis activities are general-
ly undeveloped; dissemination of results has been cut back.
Then you say that there just is no good way, they have not devel-
oped a good way, of assessing technology. Then you conclude with
this very strong statement that one is left with the impression that
HCFA is delaying payment for transplants for cost containment
reasons. You state: "If this is a true perception this is a serious per-
version of the process of technology assessment and its place in pol-
icymaking." That is a very, very strong statement.
In the earlier panel, we had the fellow from CHAMPUS turning
down the transplant procedure for the children that need it cov-
ered by CHAMPUS on the basis of the slow progress being made—
on the basis of the decisions made by HHS. HHS, when we turned
to them, said that their process is, they think, a good one, and that
they are just moving along as far as they can.
But here you, with the Office of Technology Assessment, have
conducted an exhaustive study of exactly the procedures that are
being used at HHS, and you say they are inadequate, and you are
left with the impression that they are delaying payment for cost
containment reasons, a serious perversion of the process of technol-
ogy assessment and its place in policymaking. That is a very, very
strong statement.
Let's take a closer look at the heart transplant question here.
Now, this National Center for Health— what does NCHCT stand
for again?
Dr. Banta. The National Center for Health Care Technology.
Mr. Gore. Now, that was established by the Congress in 1978
Dr. Banta. Yes, sir.
Mr. Gore [continuing]. As a way to make precisely the decisions
that are not being made, or that are being made so slowly, with
respect to transplants. Correct?
Dr. Banta. That is correct, sir.
Mr. Gore. Liver transplant.
Dr. Banta. And it was set up to address both elements, both the
general technology assessment function and the coverage question
for medicare.
Mr. Gore. Now, as part of the Gramm-Latta budget resolution—
that was the great big thing that contained the whole Federal Gov-
ernment all in one fell swoop — this Center was abolished in that
legislation. Is that correct?
Dr. Banta. Yes, sir, but I should note that the administration
put no money in their own budget for the Center. Congress could
have reversed the administration's decision, but it was fundamen-
tally the administration's decision.
Mr. Gore. Even before Gramm-Latta
Dr. Banta. That is correct.
Mr. Gore [continuing]. The administration decided that they did
not want this. Do you know why?
Dr. Banta. It is hard to say, Mr. Chairman. There have been a
lot of speculations, and I guess the one that I have tended to be-
608
lieve myself is that David Stockman had some concerns about a
Center that was established in legislation that was supported pri-
marily by Senator Kennedy. [Laughter.]
Mr. Gore. All right.
Dr. Banta. There are many other factors, but that at least is my
own interpretation.
Mr. Gore. Now, before it was abolished, it looked at the question
of heart transplants and decided that they ought to be approved by
HCFA.
Dr. I^nta. Yes, sir, under specified circumstances.
Mr. Gore. In carefully specified circumstances.
Dr. Banta. That is right.
Mr. Gore. But HCFA decided to ignore that recommendation?
Dr. Banta. Yes, sir, the details of the situation were that medi-
care was paying for heart transplants at Stanford University under
an interim decision. About the same time that NCHCT made its
recommendation, the University of Arizona billed for a procedure,
was denied by medicare, and the University of Arizona appealed to
an administrative law judge, who found that medicare must pay
the University of Arizona if it was going to pay Stanford.
This, I think, raised the question in the Secretary's mind as to
whether the Department could limit payment to certain selected
centers, and the decision was made not to pay at all rather than
try to pay in certain selected centers.
Mr. Gore. I see. And you have some difficulty escaping the con-
clusion that they are not really assessing the technology; they are
just deciding that they don't want to spend that money.
Dr. Banta. Well, you have heard from Roger Evans at these
hearings. Dr. Evans is a very good researcher, and I think the re-
search project is very well worth doing. That is a separable ques-
tion from whether heart transplants should be paid for or not, how-
ever.
A procedure was set up here, a process was followed, and HCFA
did not follow out its own process in deciding whether or not to
pay. That is my objection to this particular procedure.
Mr. Gore. Now, you are aware of the provisions in the Social Se-
curity Act, just signed into law, which establishes a new commis-
sion for the purpose of assessment of medical procedures and serv-
ices, are you not?
Dr. Banta. Yes, sir, very aware.
Mr. Gore. This legislation provides for OTA to appoint the com-
mission.
Dr. Banta. Yes, sir.
Mr. Gore. What other role do you foresee for OTA?
Dr. Banta. Well, the way we formulate our role at the minute is
that we would appoint the commission, as you say, with a process
of the greatest integrity that we could devise.
After that, we would stand back and let the commission function
independently, but we do have a responsibility to report to the Con-
gress once a year on the functioning of that commission.
Mr. Gore. I see.
Dr. Banta. I am glad you brought up the commission because I
think it is a very good example of how procedures can be set up for
609
the purpose of assuring that new beneficial technology is incorpo-
rated into the medicare program.
Mr. Gore. Now, can that commission perform the role that the
one that was just abolished performed?
Dr. Banta. Yes, Mr. Chairman, it will certainly perform part of
that role. Since the DRG program only covers hospital care under
the legislation, though, there still is all the rest of medical practice
to consider.
Medicare coverage decisions deal primarily with physicians. The
new commission will take over a piece, but most of it would remain
with the old remnant.
Mr. Gore. In your view — now, you have looked at the procedures.
Dr. Davis outlined her procedure with the seven steps and all the
boxes and stuff. Is that the one that you are saying is inadequate?
Dr. Banta. The comments about inadequacy were really ad-
dressed to a broader question, not so much the way the medicare
program and the Public Health Service carry out their functions
but that, in my view, at least, the Federal Government has a
broader responsibility to assure that medical technology is safe and
efficacious.
The Federal Government's activities in this area are really inad-
equate. I think the medicare program in general, since 1978, has
done a pretty good job of assessing the technologies that have come
before it, and the Public Health Service, with NIH, CDC, and all
the other resources of the Public Health Service have done that
pretty well. So, when I pick out heart transplant as an instance to
criticize, I think that is an almost unique instance, and I do not
know enough, frankly, about the evidence of liver transplant to say
if that should be covered or not.
Mr. Gore. All right. I was just about to ask you about that. The
evidence that has been presented to us indicates a 70- to 80-percent
success rate in those centers that are doing the procedure.
Dr. Banta. I do have the same concern that you do, Mr. Chair-
man. Liver transplant was first considered by the Public Health
Service 2V2 years ago.
Mr. Gore. Yes.
Dr. Banta. And the people who participated in that process at
NIH and NCHCT told me informally that they anticipated the
question would have to be reopened soon because of the accumulat-
ing evidence.
Mr. Gore. Yes.
Dr. Banta. So, I think your putting your finger on the question
of slowness is exactly the right point. It is not so much that the
procedures are inadequate. The procedures are important and they
generally run very well, but they run very slowly, at least in these
cases of transplant.
Mr. Gore. Yes; well, you are familiar with the general frame-
work of bioethics. You have to be in pursuit of your work. At what
point does the slowness of the reevaluation acquire bioethical im-
plications? If patients are dying while the decisionmaking process
is dragging on, at some point it seems to me we have a bioethical
imperative to make those decisions in a more expeditious fashion.
Wouldn't you agree?
610
Dr. Banta. I certainly agree with that. It is a difficult area.
When people are dying, they are desperate; the physicians are des-
perate; and there is a tendency to use things prematurely. And so I
am sympathetic with the Department's desire to approach those
questions carefully. But still, I stand by what I said in the case of
heart transplant, that at least in that case I think the decision
should have been made some time ago.
Mr. Gore. Now, clinical trials are expensive and difficult to per-
form. Yet, they are generally regarded as necessary for judgments
on new therapies and procedures to be made appropriately.
Who should have the responsibility for supporting these studies?
Should it be NIH or HCFA or this new assessment agency that you
are appointing? Who should do that?
Dr. Banta. Well, I don't see one responsibility, Mr. Chairman. I
think the private sector certainly supports clinical trials. The larg-
est supporter of clinical trials in this country, aside from NIH, is
probably the drug industry, because they are required to do clinical
trials under the drug regulation statutes.
There are many sources of funding and support for clinical trials.
But there are inadequate funds, and this kind of research, just like
biomedical research, does not attract large private sector resources.
I think the public wants to be assured that medical technology is
safe and efficacious, and I believe the public is ready to pay out of
its own funds to assure that appropriate clinical trials are done.
So, I would say not so much that it is NIH's responsibility as
that the Federal Government has a broad responsibility, and Con-
gress has some responsibility to see where that kind of program
would actually be carried out.
Mr. Gore. All right, very good.
Without objection, I want to include in the record the entire text
of your summary, "Strategies for Medical Technology Assessment,"
dated September 1982. I think it is the single best work that has
been done on these questions, and I want to congratulate you and
your colleagues at OTA for the work which went into that. I trust
it will be a useful part of this hearing record as those who read it,
hopefully, will be trying to figure out how we can solve these prob-
lems.
[Material to be supplied follows:]
611
STRATEGIES FOR
MEDICAL TECHNOLOGY
ASSESSMENT
SEPTEMBER 1982
Summary
sivres c
CONGRESS OF THE UNITED STATES
Office of Technology Assessment
Washington D C 20510
612
Office of Technology Assessment
Congressional Board of the 97th Congress
TED STEVENS, Alaska, Chairman
MORRIS K. UDALL, Arizona, Vice Chairman
Senate
ORRIN G. HATCH
Utah
CHARLES McC. MATHIAS, JR.
Maryland
EDWARD M. KENNEDY
Massachusetts
ERNEST F. HOLLINGS
South Carolina
HOWARD W. CANNON
Nevada
House
GEORGE E. BROWN, JR.
California
JOHN D. DINGELL
Michigan
LARRY WINN, JR.
Kansas
CLARENCE E. MILLER
Ohio
COOPER EVANS
Iowa
JOHN H. GIBBONS
(Nonvoting)
Advisory Council
CHARLES N. KIMBALL, Chairman
Midwest Research Institute
EARL BEISTLINE
University of Alaska
CHARLES A. BOWSHER
General Accounting Office
CLAIRE T. DEDRICK
California Land Commission
JAMES C. FLETCHER
University of Pittsburgh
S. DAVID FREEMAN
Tennessee Valley Authority
GILBERT GUDE
Library of Congress
CARL N. HODGES
University of Arizona
RACHEL McCULLOCH
University of Wisconsin
WILLIAM J. PERRY
Hambrecht & Quist
DAVID S. POTTER
General Motors Corp.
LEWIS THOMAS
Memorial Sloan-Kettering
Cancer Center
Director
JOHN H. GIBBONS
The Technology Assessment Board approves the release of this report. The views expressed in this report are
not necessarily those of the Board, OTA Advisory Council, or of individual members thereof.
613
Foreword
This summary presents the findings of OTA's study Strategies for Medical
Technology Assessment. OTA began the study in July 1980, at the request
of the House Committee on Energy and Commerce.
The full report focuses on the flow of information that is central to an
effective assessment system. It critiques the current assessment system with
respect to identifying medical technologies for assessment; developing and
synthesizing information about such technologies' health, economic, and
social effects; and disseminating this information to health care decision-
makers. This summary presents the highlights of that critique. It also pro-
vides a list of policy options, both legislative and oversight, for Congress
to improve the system.
During the course of this assessment, both the House Committee on En-
ergy and Commerce and the Senate Committee on Labor and Human Re-
sources requested that OTA study several specific areas in more depth. In
response to these requests, OTA is publishing three other volumes: 1) a
report on medical technology under proposals to increase competition in
health care, 2) a report on the postmarketing surveillance of prescription
drugs, and 3) a technical memorandum on MEDLARS (the National Library
of Medicine's Medical Literature Analysis and Retrieval System) and health
information policy. Another paper, funded as part of this assessment, con-
cerns the potential role of Professional Standards Review Organizations
in medical technology assessment.
Drafts of the final report were reviewed by the advisory panel chaired
by Dr. Lester Breslow, by the Health Program Advisory Committee chaired
by Dr. Sidney S. Lee, and by approximately 100 other individuals and
groups representing a wide range of disciplines and perspectives. We are
grateful for their many contributions. As with all OTA reports, however,
the content is the responsibility of the Office and does not constitute con-
sensus or endorsement by the advisory panel or the Technology Assess-
ment Board.
JOHN H. GIBBONS
Director
614
Advisory Panel for Strategies for
Medical Technology Assessment
Lester Breslow, Panel Chairman
School of Public Health, University of California, Los Angeles
Morris Collen
Director of Technology Assessment
Kaiser Permanente Medical Croup
Richard Cooper
Williams & Connolly, Inc.
D. V. d'Arbeloff
Chairman and Chief Executive
Officer
Millipore Corp.
Harvey Fineberg
Harvard School of Public Health
Jerome D. Frank
The Henry Phipps Psychiatric Clinic
The Johns Hopkins Hospital
William Goffman
School of Library Science
Case Western Reserve University
Leon Greene
Vice President
New Product Technology
Smith, Kline & French Laboratories,
Inc.
David B. Horner
Orthopedic Surgeon
Stanley B. Jones
Vice President
Blue Cross /Blue Shield Association
F. Wilfrid Lancaster
Graduate School of Library and
Information Science
University of Illinois
Louise B. Russell
Senior Fellow
The Brookings Institution
Herbert Semmel
President
Consumer Coalition for Health
Robert M. Veatch
Kennedy Institute of Ethics
Georgetown University
Richard W. Vilter
American College of Physicians
College of Medicine
University of Cincinnati
Kenneth E. Warner
School of Public Health
University of Michigan
Richard N. Watkins
Staff Physician
Group Health Cooperative
Carol Weiss
Graduate School of Education
Harvard University
Kerr L. White
Deputy Director for Health Sciences
Rockefeller Foundation
615
OTA Project Staff—Strategies for
Medical Technology Assessment
H. David Banta, Assistant Director, OTA
Health and Life Sciences Division
Clyde J. Behney, Health Program Manager
Bryan R. Luce, Project Director
Dale A. Carlson, Analyst
John C. Langenbrunner, Analyst
Gloria Ruby, Analyst
Kerry Britten Kemp, Editor
Virginia Cwalina, Administrative Assistant
Mary E. Harvey, Secretary
Pamela Simerly, Secretary
Lorraine G. Ferris, Secretary*
Nancy L. Kenney, Secretary**
Other Contributing Staff
Ann Rose, Senior Analyst
Arthur Kohrman, Congressional Fellow
Hellen Gelband, Analyst
Mark Hochler, Intern
Lisa Scheffler, Intern
Harvey Sepler, Intern
Principal Contractors
Rand Corp.
John P. Bunker, Stanford University
Lawrence Miike
John B. Reiss, Baker and Hostetler
Leonard Saxe, Boston University
Paul M. Wortman, University of Michigan
OTA Publishing Staff
John C. Holmes, Publishing Officer
John Bergling Kathie S. Boss Debra M. Datcher Joe Henson
"Until January 1982.
"Until September 1981.
616
Strategies for Medical
Technology Assessment
Knowledge advances by steps, and not by leaps.
— Thomas Babbington Macaulay
NEED FOR A STRATEGY
Several reasons for assessing medical technologies have been presented
in previous OTA reports, Assessing the Efficacy and Safety of Medical Tech-
nologies and The Implications of Cost-Effectiveness Analysis of Medical
Technology. The main reasons are to help ensure that medical technolo-
gies are safe, efficacious, and appropriately used. Whether current policies
and practices for medical technology assessment achieve these and related
objectives is the subject of this report. Having studied both the methods
of medical technology assessment and the dissemination of information de-
veloped by technology assessment, OTA finds that a strategy is needed to
implement the assessment process to make it more effective. OTA also finds
that greater attention to assessment of social and ethical values is needed
for policymaking.
A medical technology, as used in this report, is a drug, device, or medical
or surgical procedure used in medical care. (The term may also apply to
the organizational and supportive systems within which medical care is de-
livered, but those systems are not the focus of this report,) Medical tech-
nology assessment is, in a narrow sense, the evaluation or testing of a tech-
nology for safety and efficacy. In a broader sense, it is a process of policy
research that examines the short- and long-term consequences of individual
medical technologies and thereby becomes the source of information needed
by policymakers in formulating regulations and legislation, by industry in
developing products, by health professionals in treating and serving pa-
tients, and by consumers in making personal health decisions. Unfortunate-
ly, that process currently has deficiencies that cause or allow confusion to
exist at all decision points.
Historically, medical technology assessment has developed incremental-
ly as responses to specific demands. Taken singly, some of these responses
have been coherent (e.g., the Food and Drug Administration's (FDA's) pre-
marketing approval process which was developed to protect the public from
unsafe and inefficacious new drugs). Taken in combination, however, these
various responses do not constitute a coherent system for assessing all classes
of medical technologies. The present approach is characterized by multiple
participants from the public and private sectors, and by uncoordinated ac-
tivities. Complicating matters further is the large number of medical tech-
617
nologies in use, with thousands of new technologies appearing every year.
The result is an overload and confusion among decisionmakers and con-
sumers.
OTA finds that a strategy is needed to guide the selection and implemen-
tation of components that would constitute a coordinated system of medical
technology assessment. The basis of the strategy should be the values and
available resources in a free-market economy, coupled with the social re-
sponsibility to make available safe, effective medical care. The vehicle of
the strategy should be a systematic process of information development,
dissemination, and use. The target should be to address the confusion deriv-
ing from the lack of information available to decisionmakers.
Minimally, the following components of an assessment system must be
considered in developing a strategy:
1. the values of individuals and of society concerning medical technolo-
gies and their use;
2. the goals and appropriate role of medical technology assessment in
society;
3. the types of assessment information needed for decisionmaking;
4. the methods and technologies for developing and acquiring the infor-
mation; and
5. mechanisms for disseminating and applying the information, including
programs that will use the information.
A strategy for assessing medical technologies must consider not only the
methods of assessment, but also the needs, demands, and resistances of po-
tential participants in the process of assessment. Specifically, the public itself
as consumers; health care professionals as users; industry as innovators,
producers, and reimbursers; and the Federal Government simultaneously
as purchaser and guardian must be informed and active in setting mutually
compatible goals for technology assessment. Each sector has health, social,
and economic values underlying its decisionmaking. Clarifying those values
and realistically accommodating them will require developing not just more,
but also more reliable, information about the safety, efficacy, cost effec-
tiveness, and social and ethical implications of all classes of medical tech-
nologies. The inconsistencies and contradictions in available information
are reflected in the inconsistent and competing pressures from the various
sectors.
DIMENSIONS OF THE NEED
AND THE PROBLEM
Most medical technologies have a therapeutic or diagnostic value for
specific problems under appropriate circumstances. The difficulty is deter-
mining for whom and under what circumstances use of a technology is valid
or worth the tradeoff of risks and benefits. Mammography and radical
mastectomy, for example, have a place in the detection and treatment of
breast cancer, but understanding exactly what that place is may take years
and a certain amount of trial and error.
618
Government
The Federal Government's interest in developing clear policies and an
effective strategy for assessing medical technology derives from its tradi-
tional role as guardian of the public's safety and of social equity and from
its concerns about economic issues. As protector of the public, the Gov-
ernment seeks to ensure that health care is not only safe but also efficacious.
As the single largest buyer of health services, the Government seeks to en-
sure that all citizens, especially the poor, have health care available to them;
but the Government is also concerned about rising health care costs in gen-
eral and specifically about those it pays for directly through programs of
service or reimbursement (Medicare, for example) and through biomedical
and other health research. Any policies the Government sets will affect not
only the Government itself, but the public and private industry, and such
policies must especially be justifiable when the public and private industry
make self-interested demands.
The Public
The public is often neither fully informed about the safety and efficacy
of individual technologies nor educated about the issues of cost and social
values that must be considered in the adoption of a technology. The public
mixes facts with beliefs, hopes, and fears and translates those into confused,
contradictory, and often impossible demands.
For example, the public hears of a drug, perhaps one used in another
country, and wants it immediately available to patients in the United States,
especially when available therapies are ineffective. The desperation in-
dividuals feel tends to outweigh the fear of any risks that might be involved,
and they demand the right to take personal responsibility for use of the
drug. Perhaps assuming that if a therapy is used in a European country,
it has already met rigorous assessment standards, the public perceives itself
as being denied a cure for no valid reason.
Simultaneously to demanding speedy availability and personal respon-
sibility, however, the public demands protection against all forms of un-
safe medical practice and is prepared to sue for mistakes. Perhaps because
of the rigor which FDA applies to approval of new drugs and because of
Government safety standards applied to so many nonmedical products, the
public assumes that it is likewise protected in undergoing any medical or
surgical procedure recommended.
The confused demands of the public can be viewed either as irrational
or as a frustrated reflection of the deficiencies that do exist in the Nation's
approach to assuring the availability of safe, effective, and cost-effective
medical technologies. Numerous needs and values are implied in the de-
mands of the public and must be taken into account when planning a strat-
egy of policies and procedures for medical technology assessment.
8
619
Health Professionals
Health professionals often find themselves in circumstances that require
decisions based on inadequate information. The flaws in the information
flow to physicians and other health professionals are numerous: there is
not enough information available about the safety, efficacy, costs, and social
values of medical technologies; much existing information is of dubious
quality and is therefore unreliable; the practical significance of data is usually
not interpreted for clinicians; and easy access to the appropriate information
is rare.
Furthermore, medical education typically does not train physicians and
other health care professionals to make decisions based on a consideration
of values. They are trained to seek the most reliable technique to produce
a desired physiological response. As an illustration, in the issue of saving
the lives of extremely premature babies in incubators, physicians, by train-
ing, would tend to be concerned mainly with choosing the technology that
would support life. Physicians would less likely know or be concerned about
the implications of the survival of the deformed or retarded infant— impli-
cations for the infant itself, for the family, and for society. Thus, develop-
ing and supplying the right kind of assessment information to health care
professionals is essential to a strategy for medical technology assessment.
Industry
From the point of view of the private sector, of producers of technologies,
and of third-party payers, the assessment of medical technologies is both
advantageous and disadvantageous. Government's involvement in the as-
sessment process raises primarily financial issues for the private sector.
Industry, which invests money in research and development (R&D), is
willing to do so if there is a potential market for the device or drug; how-
ever, excessive regulation or the wrong kind of regulation by the Govern-
ment could discourage innovation if companies fear that assessment will
ultimately preclude marketing their product or making a profit from it.
Private third-party payers, on the other hand, might welcome shifting
the entire burden of assessment to the Federal Government. They must make
decisions about reimbursement— whether to reimburse for specific pro-
cedures and if so how much— but they have little incentive to conduct their
own assessments of procedures because of the expense. Assessment infor-
mation tends to be widely available and not proprietary; the insurance com-
panies cannot profit individually from conducting assessments. The failure
of industry members to adequately conduct assessment activities on their
own puts a heavy responsibility in the Government domain.
Nature of the Challenge
The market for medical technologies is moderated by individual consumer
tastes and financial constraints. To perhaps a greater degree, it is influenced
620
by policies that determine what kinds of research will be supported, what
regulations restrict market entry, and which technologies will be reimburs-
able by Government or private programs.
No policy decision has isolated effects in just one sector; repercussions
occur throughout the entire social and economic fabric of the Nation. A
regulatory decision to require extensive, expensive assessment of a medical
device in a developmental phase, but not to offer industry assistance in the
assessment, for example, could lead to a decision by industry never to begin
the innovation phase. An idea might never be realized which eventually
could have best served the public. In fact, current policies and procedures
for assessment are not adequate to fully serve the public interest. No con-
sistent policy or system exists for assessing all classes of medical technologies,
nor even for various technologies within a class.
Reimbursement decisions also influence the innovation and adoption of
medical and surgical procedures. Although new procedures tend to be
adopted and reimbursed without adequate assessment, in the case of truly
innovative procedures, third-party payers sometimes refuse reimbursement.
While encouraging new applications, slight modifications, and excessive
use of existing technologies, the present reimbursement system may dis-
courage radical innovations.
» The challenge in developing a strategy for assessment is to develop a sys-
tem that will serve the public interest by encouraging the development and
appropriate use of needed and safe medical technologies without un-
necessarily discouraging innovation and production.
CONCEPTUAL FRAMEWORK FOR
MEDICAL TECHNOLOGY ASSESSMENT
Medical technology assessment involves numerous components and sub-
components at various stages of the process. Though these do not exist as
a coherent system, discussion of them is facilitated by describing a systematic
framework. The multiple components of the medical technology assessment
process can be conceptualized as an information flow associated with the
following four stages of assessment (see fig. 1):
• Identification. — Monitoring technologies, determining which need to
be studied, and deciding which to study.
• Testing. —Conducting the appropriate analyses or trials.
• Synthesis. — Collecting and interpreting existing information and the
results of the testing stage, and, usually, making recommendations or
judgments about appropriate use.
• Dissemination. — Providing the synthesis of information, or any other
relevant information, to the appropriate parties who use medical tech-
nologies or make decisions about their use.
This four-stage process is applicable to the three classes of medical tech-
nologies mentioned earlier — namely, drugs, devices, and medical and surgi-
10
621
Figure 1.— Process of Assessing
Medical Technologies
Identification
I
Testing
Synthesis
Dissemination
SOURCE: Office of Technology Assessment.
cal procedures. It is also applicable to any technology in any of four typical
stages of development, loosely defined as follows:
• Emerging technology. —A technology in the phase prior to adoption.
• New technology. — A technology in the phase of adoption.
• Existing technology. —A technology in general use.
• New application of an existing technology.— A new application of a
technology in general use.
Visualizing the lifecycle of a hypothetical technology (see fig. 2) makes
obvious some of the decision points at which assessment information is es-
sential. If an emerging technology is a drug or device, industry must decide
whether to commit resources to develop it; must later decide whether to
market it; and must ultimately decide whether to maintain, alter, or discard
it. If a new drug or a certain class of device is to be marketed, FDA must
decide whether to grant market approval based on safety and efficacy cri-
teria. If the new technology is to be used in medical practice, someone must
decide whether to pay for it. In some cases, the Health Care Financing Ad-
ministration (HCFA) must decide whether to include a new technology or
a new use of an existing technology as a reimbursable expense for Medicare
beneficiaries. Private insurers, such as Blue Cross/Blue Shield and health
maintenance organizations, must make similar decisions. Hospitals must
decide whether to purchase, and practitioners and their patients must decide
whether to use, the technology.
11
622
Figure 2.— Lifecycte of a Medical Technology
Hfecyc'le ** Emerging technology -
Activities
in the
lifecyele
Existing
— — Ne* technology ♦*- techno|ogy ■*
. New application ot_
existing technology
Obsolescence
zz.
Widespread
use
Basic
research
Applied
research
Development
U
Adoption
Policy Technical and
areas I biomedical R&D
Drug and device m Marhe„
approval
Nonuse
Health services R&D
Evaluation
Regulation
i
j Financing |
SOURCE: Office of Technology Assessment.
In contrast to drugs and devices, medical and surgical procedures and
their variations are ordinarily developed by clinicians and researchers and
therefore seldom require investment decisionmaking by industry. Further-
more, under the present system, medical and surgical procedures are not
regulated for safety and efficacy by FDA and thus tend to escape the reg-
ulatory decisions. Nevertheless, decisions about the use of such procedures
must be made.
Many medical technologies in use have not been adequately evaluated.
If all medical technologies were adequately assessed as emerging or new
technologies, there would be less need for assessing existing technologies.
In addition to considering the stages of the assessment process and the
classes and developmental stages of technologies, an assessment system re-
quires the measuring of specified effects. Depending on the technology, the
effects to be considered are health (safety, efficacy, and effectiveness),
economic, or social. Once the categories of effects to measure have been
determined, testing and analysis may begin. Throughout the assessment
process, all information and decisions must be balanced against the moral
and ethical values of society.
IDENTIFICATION: TECHNOLOGIES NEEDING
ASSESSMENT
A decision to conduct a technology assessment must be preceded by the
identification of technologies that should be assessed and the setting of pri-
orities among candidate technologies. Identification procedures may vary
with the type of technology, but basically can be classified as one of three
types: 1) routine mechanisms, 2) priority-setting mechanisms, and 3) mech-
12
623
anisms of opportunity. Routine mechanisms systematically identify a class
of technologies, usually in relation to a specific event— e.g., FDA requires
that all drugs and devices be registered before they can be marketed or tested
in humans. Priority-setting mechanisms are used, as needed, to apply im-
plicit or explicit criteria to determine which technologies should be
assessed— e.g., HCFA and the National Institutes of Health (N1H) set re-
search agendas. Mechanisms of opportunity are not formalized but are val-
uable in identifying technologies as they surface or become important —
e.g., patient outcome data may bring the need for analysis to the attention
of researchers or the public.
Identifying medical technologies for priority-setting and assessment is an
important responsibility primarily of several agencies within the Depart-
ment of Health and Human Services (DHHS): FDA, the National Center
for Health Services Research (NCHSR), NIH, and HCFA. The National
Center for Health Care Technology (NCHCT), while it was funded, also
identified technologies for assessment.
FDA identifies new drugs and medical devices through its premarket ap-
proval authority. To test promising new drugs in humans, drug sponsors
(e.g., manufacturers) must notify and receive permission from FDA through
a "notice of claimed investigational exemption for a new drug" (IND). If
the drug successfully passes this premarket testing, the sponsor may file
for a "new drug application" (NDA), which is a request for FDA's permis-
sion to market the drug. Since 1962, when this regulatory mechanism was
instituted, FDA has reviewed over 13,500 applications for INDs and has
approved about 1,000 NDAs. In 1976, FDA was also given expanded respon-
sibility for regulating medical devices. In the first 4 years of implementing
the 1976 Medical Device Amendments, about 98 percent of the listed devices
in the 10,540 premarket notifications received were claimed to be "substan-
tially equivalent" to preexisting devices. In 1981, FDA estimated that 2,300
premarket notifications would be reviewed. New applications of existing
drugs and devices must also meet premarket approval requirements, but
the initiative for these new applications remains with the manufacturer, not
with FDA. FDA does support some monitoring activities of existing drugs
and requires manufacturers to report adverse reactions, but these postmar-
keting surveillance activities are focused on the safety aspects of these drugs,
not on refinements in use or new uses.* Nevertheless, postmarketing surveil-
lance has the potential of becoming an effective method of identifying ex-
isting technologies in need of further assessment.
NIH and NCHSR are research agencies that identify emerging and some-
times new technologies in need of assessment through their priority-setting
processes for research grants and contracts. Projects are selected on the basis
of technical merit and whether they are addressing important issues. The
processes generate information useful to policy decisions, but do not nec-
essarily address the immediate priorities of operating agencies such as HCFA.
HCFA reimburses for Medicare and therefore has obvious incentives for
identifying technologies in need of assessment; nevertheless, it has no mech-
*This topic is to be explored in greater depth in OTA's forthcoming report, to be published this fall,
entitled Postmarketing Surveillance of Prescription Drugs.
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anisms for the identification of existing technologies in widespread use. For
new technologies, the identification is by opportunity. When the question
of coverage arises for new technologies, HCFA must determine whether
it has adequate information to make a decision and must set priorities for
technologies that must be assessed to provide more information. Also,
through its Office of Research and Demonstrations, HCFA sets priorities
for assessing technologies that are important to its operations.
NCHCT was established in 1978 to undertake and support assessments
of medical technology, but did not receive funding in 1982. NCHCT co-
ordinated interagency issues, but also set its priorities internally and had
its own responsibilities for identifying technologies. Specifically, NCHCT
compiled an annual "emerging technology list" as an early alert system for
assessment, but the 1981 reauthorization of NCHCT withdrew its authori-
ty to compile the list. (Industry argued that the list threatened innovation
by casting doubt on the eventual marketability of a technology.) NCHCT
also initiated a plan to develop a joint public-private model for collecting
clinical data on emerging technologies. Finally, the NCHCT Director chaired
the Technology Coordinating Committee of DHHS, which was the Depart-
ment's primary mechanism for coordination of issues associated with
medical technologies.
Overall, the identification stage of the current system of technology assess-
ment has serious shortcomings. The degree to which current processes iden-
tify technologies varies. Emerging and new drugs and devices are adequately
identified for assessment prior to their being marketed. However, emerg-
ing and new medical and surgical procedures are not adequately identified,
because no one in either the private or the Government sector has a clear
responsibility for the task. New mechanisms are especially needed to iden-
tify for the purpose of assessment existing technologies of all classes, new
applications of existing technologies of all classes, and medical and surgical
procedures in all four stages of development.
TESTING: TYPES OF INFORMATION NEEDED
AND MECHANISMS FOR TESTING
As a basis for decisions, a strategy to assess medical technologies must
take into account what is known, what is not known, what is needed, what
can be obtained, and at what cost. Information will never be perfect, and
money and time will always be limited; thus, evaluation methods must be
used judiciously and their results must be interpreted cautiously, in con-
junction with numerous other measurements, especially with consideration
for society's moral and ethical values. Three categories of information about
a medical technology are needed for policy decisions: 1) health effects,
2) economic effects, and 3) social effects. The methods and procedures for
determining these effects have strengths and weaknesses closely paralleling
those of the identification phase.
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Health Effects
Health effects are determined during the testing stage of assessment. The
basic questions asked are: Does the technology work? and How well does
it work? The former question seeks information about the technology's ef-
ficacy and effectiveness, the latter about its safety (and risk). The informa-
tion provided by analyses of health effects helps decisionmakers determine
whether a drug or device should be allowed on the market or whether fur-
ther investment in R&D is warranted.
Patient outcome is the desired endpoint measured in efficacy and effec-
tiveness analyses; efficacy is tested under ideal clinical conditions, whereas
effectiveness is tested under average, or typical, conditions. Tests for ef-
fectiveness demonstrate whether efficacy information can be generalized
to the population at large. For new drugs and certain devices in the emerg-
ing phase, efficacy must be established in preclinical, biochemical, or animal
tests before it can be tested among humans. The method that gives the most
valid and most reliable information about efficacy is the randomized clinical
trial (RCT). The strength of the RCT lies in its randomization process, pro-
ducing two or more groups that are identical except for chance occurrence,
which can be estimated statistically. The drawbacks of RCTs are that they
can only be used in certain settings, they are sometimes not ethical to con-
duct, and they do not always provide complete information about safety.
Thus, despite the highly valid information they can produce, RCTs are
not always the method of choice. Other methods can be used as substitutes
for RCTs or to supplement them. Observational methods, for example, are
designed to analyze data from nonrandomized study designs. Such methods
can be useful in ruling out competing explanations for an observed effect
and for testing hypotheses in large, diverse populations after a technology
is widely diffused. Prospective cohort studies, for example, can be used to
detect rare adverse reactions to drugs that were unsuspected prior to mar-
keting. Case-control studies are an inexpensive means of indicating whether
the use of a technology results in a small level of risk.
Another, more common type of study is the case study, typified by a
physician reporting his or her experience with particular technologies and
patients. Case studies are useful in an overall assessment strategy in that
they can facilitate the identification of technologies in need of assessment.
Case studies are important identification mechanisms of opportunity, as
defined earlier. However, the validity of case studies is extremely low
because of, among other things, observer bias and the placebo effect. Never-
theless, clinicians are very often swayed by these case reports, which fill
the medical literature and which often describe the successful application
of a technology.
Safety is measured in terms of a risk-to-benefit ratio; it is therefore a rel-
ative concept. The estimation of safety may be a byproduct of testing for
efficacy and effectiveness. A low risk may be unacceptable if there is no
benefit, but a high risk may be acceptable if the benefits are also high. RCTs
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tend to give risk information only on a small segment of the population.
To generalize to other segments, supplemental information is needed from
surveys and methods which can make use of registries and clinical data
banks.
For certain technologies, especially devices, establishing the technology's
performance integrity is a prerequisite for efficacy assessment. Perform-
ance standards usually pertain to the chemical, physical, and electric prop-
erties of devices. Similar standards are often used in evaluating technolo-
gies which have an intermediate rather than a direct effect on the patient's
health outcome, e.g., diagnostic and often prevention technologies. In such
cases, the technology is evaluated in terms of its ability to cause one effect
that in turn will cause the desired result. For example, an automatic blood
pressure monitoring device must accurately measure and record blood pres-
sure if it is to be used for diagnostic purposes.
No precise formula exists for choosing the best or most appropriate eval-
uation method. The stage of development of the technology itself — e.g.,
emerging, new, or existing — will partially determine the appropriateness
of a method. The purpose of the technology — e.g., diagnostic, therapeutic,
or preventive — will limit the range of appropriate methods. However, other
factors such as existing knowledge about the risks and benefits and avail-
able resources may influence or override otherwise "ideal" choices. The im-
portant criterion in selecting analytic methods is not which is theoretically
more sophisticated, but which is practically the most appropriate.
Economic Effects
Analytical methods to determine the economic effects of medical tech-
nologies comprise a spectrum ranging from sophisticated computer-based
data analyses to best-guess estimates of costs and benefits. The broad terms
cost-benefit analysis (CBA) and cost-effectiveness analysis (CEA) refer to
two techniques for comparing the positive and negative consequences of
alternative ways to allocate resources. The principal distinction between
the two is that CBA values all costs and benefits in monetary terms whereas
CEA produces a measure of the cost involved in terms of some desirable
health-related effects (e.g., years of life gained).
Measurements of economic effects should consider both direct and in-
direct costs. Direct costs are those associated with direct medical care usage:
the cost of the physician, the hospital, the medical supplies. Indirect costs
are associated with the value of time lost in receiving medical care and in
being sick. When indirect costs are considered in economic analyses — and
often they are not — they are frequently measured in terms of lost or gained
wages.
Economic analysis is complex and must consider more than charges for
services. For example, cost analyses should develop information on oppor-
tunity cost, marginal valuation, joint production considerations, R&D costs,
overhead, costs v. prices, and discounting. Just as no one method is in-
variably appropriate in the evaluation of health effects, no one method of
economic analysis is appropriate. The user of the information will partial-
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ly determine the kinds of analyses done. For the patient, the actual cost
of services is the important information. For policymakers, more complex
information is required. In the sequence of the assessment process, infor-
mation about the economic effects may be useless if reliable and appropriate
information about the health effects is not available.
Social Effects
Urgent ethical and social questions are being raised in areas of biomedicine
such as experimentation with human subjects, genetic engineering, human
reproduction, and the possibly inappropriate prolongation of life. Who is
affected by a medical technology? Who is not affected? What values of in-
dividuals and society are involved in use of the technology? What ethical
principles are involved in testing the technology?
To varying degrees, medical technologies may affect the personal and
work lives of patients and their families; influence the structure of medical,
legal, and economic systems; and challenge society's most fundamental be-
liefs. Considerations of the social and ethical implications of medical tech-
nologies, therefore, must take an important place in the development of
policies. Social implications are the direct or indirect effects of medical tech-
nology on the concepts, relationships, and institutions society considers im-
portant. Ethical questions in relation to medical technologies — especially
those concerning principles of distributive justice, respect for individuals,
and benevolence — may also have profound social implications.
Unlike health and economic effects, social and ethical issues do not lend
themselves to quantitative measurement and analysis. However, the sys-
tematic identification and evaluation of the social impacts resulting from
the use of medical technologies can be crucial. A related task is to identify
the values that underlie policy alternatives, including moral and ethical
values. Systematically assessing values does not necessarily elucidate a
single, clear, conclusive answer about which policy to adopt; but, rather,
it clarifies the array of choices, the reasons for disagreements, and the com-
promises required.
A second aspect of assessing values is to make a reasonable inquiry into
the values that permeate and underlie the assessment itself. Value judgments
enter into every aspect of technology assessment; they determine which tech-
nologies will be assessed and at what phase of their development, the scope
of assessments, the kinds of data that will be collected and analyzed, the
methods of the assessment, and how the assessment findings will be used
in decisionmaking. It is important to clarify, therefore, why an assessment
of a particular technology was initiated and how it fits into larger cultural
and political contexts, what affects the performance of assessment (e.g.,
the choice of assessors and the analytic goals and methods), and what values
affect the application of the results.
Mechanisms for Testing
The major problem with the testing phase of the current assessment system
is the lack of a systematic approach for testing identified technologies in
all phases of development for all types of required information.
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FDA, in its regulatory role, is probably the most significant agency in
stimulating technology testing. Most FDA regulation requires industry to
test, according to approved protocols, new drugs and many medical devices
for safety and efficacy. For drugs, Phase I studies are studies to determine
levels of tolerance (toxicity), followed by early dose ranging studies for safe-
ty and sometimes efficacy. If safe, the drug can be tested in Phase II studies
to demonstrate efficacy and relative safety under controlled conditions.
Phase III studies are expanded controlled and uncontrolled clinical trials.
If these trials are successful, the company may file an NDA. FDA then re-
views the data and may approve the drug for marketing. Since 1962, FDA
has approved about 1,000 NDAs. For devices, FDA requires that 90 days
notice be given about any new device industry intends to market. If a device
does not meet safety and performance standards for its assigned clas-
sification, or if adequate information is not available for such a determina-
tion, FDA may require testing of the device. For drugs and devices, FDA's
assessment activities are generally limited to safety and efficacy and do not
involve cost, cost effectiveness, or social effects.
Unlike drugs and devices, medical and surgical procedures are not regu-
lated, and their testing, if done, is through research whose funding comes
primarily from NIH and from private foundations. The costs of the later
developmental phase of procedures tend to be paid by patients (or by the
Government), usually through standard medical insurance policies, even
when the procedure has been clearly designated as experimental. Medical
and surgical procedures usually begin as user-generated innovations; for
example, a surgeon may modify an existing technique during surgery. In-
creasingly, innovations arise in academic centers, from researchers who
know how to present their innovations in a technically acceptable manner
at professional meetings and in journals. These researchers' presentations
tend to encourage the adoption of innovations without their receiving a
routine, formal examination for safety and efficacy.
Whereas FDA regulations affect efficacy and safety, four other regulatory
programs are concerned with cost issues: section 1122 review, State certifi-
cate-of-need laws, the National Health Planning and Resources Develop-
ment Act of 1974, and Professional Standards Review Organizations
(PSROs). Although HCFA, which makes reimbursement policy, has its own
research arm, the Office of Research and Demonstrations, it has seldom
conducted technology assessments. NCHCT, an agency legislatively man-
dated to support comprehensive assessments of health care technologies for
all effects (including health, economic, and social), was not funded for 1982.
Social assessment activities have been conducted by several Government
mechanisms. OTA was established in 1972 as an analytic support agency
to conduct policy research on science and technology issues for congres-
sional committees. OTA's health-related reports have focused primarily on
methods available for assessing technologies and issues prompted by their
use. The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research was established in 1974 to develop eth-
ical guidelines for conducting research in human subjects. The National
Commission produced numerous reports with recommendations, many of
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629
which were adopted by DHHS, * particularly those governing the protec-
tion of human subjects. The Ethics Advisory Board, which was established
in 1978 at the National Commission's recommendation but was not funded
in 1980, was mandated to review ethically problematic research protocols
and research involving human projects. The board fielded queries from other
DHHS agencies such as NIH and the Centers for Disease Control. The Presi-
dent's Commission for the Study of Ethical Problems in Medicine and Bio-
medical and Behavioral Research succeeded the National Commission in
1978. Members of the President's Commission are appointed representatives
from DHHS, the Department of Defense, the Veterans Administration, the
Central Intelligence Agency, the National Science Foundation, and the White
House Office of Science and Technology Policy. The President's Commis-
sion conducts studies in medical practice and biomedical research and ex-
amines five subjects for legal and ethical implications: informed consent,
privacy, uniform definition of death, genetic issues and unborn humans,
and availability of health services. NCHCT's responsibilities, as mentioned
above, included assessment of the ethical, legal, and social implications of
medical technologies.
SYNTHESIS: USING INFORMATION AS
THE BASIS FOR DECISIONS
Synthesis of the information generated during the testing stage of the as-
sessment process is the necessary step to providing a convincing and re-
sponsible basis for decisions made during all phases of a technology's life-
cycle.
The synthesis activities that pertain to medical technology assessment
fall into two broad areas: 1) synthesis of the results of individual research
studies; and 2) synthesis of a body of research findings with various con-
cerns such as risk, social, ethical, or cost factors. The first type of synthesis
addresses questions of safety, efficacy, or effectiveness of a given technology;
the latter is more policy oriented, often seeking to set guidelines or stand-
ards for medical practice or reimbursement policy. The value of the latter
depends, in large part, on the adequacy of the former.
Synthesis of Research Findings
The traditional approach to synthesizing research information is the lit-
erature review, an article summarizing the data of those studies a reviewer
believes to be the most relevant to the topic under review. Literature reviews
are useful and heavily relied on, but because of their scope and the delays
in the journal publication system, such reviews are rarely timely, especial-
ly in reporting an ineffective or unsafe technology. Furthermore, the reviews
are subjective and often have no commentary on methodological problems
in individual studies.
More systematic procedures for integrating and interpreting sets of re-
search evidence do exist and can be employed. The most simple technique
*Then the Department of Health, Education, and Welfare.
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is a simple classification technique, sometimes called the "voting method."
This technique involves selecting a sample of evaluative studies, coding some
aspect of the design, classifying outcomes as favorable, neutral, or un-
favorable and constructing tables of research findings. The method iden-
tifies methodological strengths and weaknesses among studies and can help
determine patient populations and under what conditions they are most
likely to benefit from a technology.
Meta-analysis is a technique that assesses the magnitude of treatment im-
pact by quantitative comparison of actual study results. This method is par-
ticularly useful in assessing treatments for which a large number of studies
are available and findings across studies seem to have great variability. How-
ever, it may have drawbacks with respect to sample selection.
Currently, no single technique is fully adequate for synthesizing research;
however, the application of formal quantitative procedures is beginning
to give a better understanding of methodological problems in research itself.
Formal procedures can segregate differential outcomes according to treat-
ment characteristics and methodological approaches. Contradictions can
then be identified, analyzed, or further researched. In the performance of
formal quantitative analyses, an important suggestion is that the significance
of the results should be interpreted and reported in language that is useful
to decisionmakers.
Synthesis of Health, Economic, and Social Effects
How, then, does one bring together and synthesize all information avail-
able about all three categories of the effects of medical technologies— health,
economic, and social? Once specific information has been synthesized
through various methods in each of these realms, how can a decisionmaker
balance the values and interpret them into programmatic actions?
OTA's report on CEA concluded that performing an analysis of costs
and benefits can be very helpful to decisionmakers, because the process of
analysis gives structure to a problem, allows an open consideration of all
relevant effects of a decision, and forces the explicit treatment of key as-
sumptions. Formal techniques such as CEA can be used to aid in the syn-
thesis of information concerning the health and economic effects of a tech-
nology. OTA found, however, that although CEA can be useful as a deci-
sion-assisting tool, it exhibits too many methodological and other short-
comings for the numerical results to be used as the basis of policy or pro-
gram decisions. For example, although CEA can be used to synthesize infor-
mation concerning health and economic effects, it cannot in itself adequately
address social and ethical issues. These have to be addressed more fully
by other means.
The most appropriate approach to any assessment is to perform it in an
open forum so that assumptions and underlying values can be challenged;
to identify, measure, and, to the extent possible, value all relevant ben-
efits/effects and costs; and to present the results of the analysis as an "ar-
ray" of benefits/effects and costs rather than forcing the results into a single
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631
aggregate measure. By arraying effects in a systematic fashion, one can place
the appropriate relative emphasis on given effects whether they are quan-
tifiable or not. This technique is designed to make more explicit the health,
economic, and social consequences of any decision.
Synthesis off Opinion
Synthesis of information may occasionally present a clear-cut indication
of the next stage of assessment or phase of technology development. More
likely, uncertainty will still predominate for decisionmakers. The uncer-
tainty may reflect the presence of random events or may reflect a basic lack
of knowledge. The former can be analyzed by various statistical techniques:
decision analysis, confidence limits, computer simulation, sensitivity anal-
ysis. However, these techniques cannot actually resolve policy controver-
sies or substitute for informed judgment.
Policy judgments may require a synthesis of opinion which can be solicited
from groups and expert input. The most common format of soliciting group
opinions is the unstructured conference which may involve presentations,
discussions, and debates. Another informal technique is the advisory panel
approach used by many Government agencies. The four best known for-
mal techniques used in medical contexts for resolving conflicts and uncer-
tainty are: 1) the Delphi technique, 2) the nominal group process technique,
3) the consensus development conference (NIH), and 4) a computerized
knowledge base which maintains expert opinion on the state of the art of
a specific topic (e.g., the Hepatitis Knowledge Base of the National Library
of Medicine, NLM). Although these formal techniques produce more reliable
opinion information than an unstructured conference does, evidence of ef-
fectiveness is contradictory for the Delphi and nominal group processes and
sparse for the NIH and NLM processes.
DISSEMINATION OF INFORMATION
What potentially are the direct effects of dissemination of assessment in-
formation? Who should have top priority in receiving information? How
should the information be disseminated? The dissemination of assessment
information directly affects the development and diffusion processes of
medical technologies. The consideration of whether to disseminate infor-
mation is therefore weighty. If a decision is made to disseminate information
because the technology is deemed either worthy or unworthy of its next
phase of development, the information must reach, at a minimum, the deci-
sionmakers involved with the technology in any aspect of its use. That au-
dience may range from directors of R&D in private industry, to health pro-
fessionals, to the general public. Reaching the audience in a timely manner
requires a systematic approach to information dissemination, especially in
view of the pace and quantity of information development and the lack
of mechanisms for the systematic synthesis of information. In a sense, the
information available is at once too much and too little.
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Government Activities
The Federal Government produces, collects, and disseminates assessment
information. NCHSR, for example, disseminates the results of health serv-
ices research to relevant Government agencies, the research community,
and other interested parties through publications, press releases, conferences,
and workshops. In 1978, the legislation authorizing NCHSR was modified
to require that at least $1 million or 5 percent of its budget, whichever
is less, be used for dissemination activities. In response, NCHSR established
a User Liaison Program to provide substantive assistance to non-Federal
health care leaders concerned with critical policy issues and operational
problems in the organization, administration, regulation, and delivery of
health care services at State and local levels.
Monitoring NIH's dissemination activities is the responsibility of the Of-
fice for Medical Applications of Research (OMAR), established in 1978 in
the NIH Office of the Director, and assisted by the OMAR Advisory Com-
mittee. One important mechanism for dissemination is the consensus de-
velopment conference. The synthesis of opinion that is achieved at a con-
sensus conference is presented in consensus statements and supporting
materials which are distributed to practicing physicians, other health pro-
fessionals, the biomedical research community, and the public— through
a mailing list of over 21,000 names. Also, members of the press are invited
to the conferences and are encouraged to publish the results. Leading medical
journals and medical societies have published the consensus materials.
In conducting medical technology assessments, information from several
subject areas is often required. A common need in most assessments, how-
ever, is for information from the field of biomedicine. NLM is the major
Federal library resource for biomedical literature. It is the predominant
creator and disseminator of biomedical bibliographic information. NLM's
coverage of the health services literature is less comprehensive than its
coverage of the biomedical literature, in part because relevant health serv-
ices information appears in so many diverse documents.2 Another source
of information for medical technology assessments is the National Technical
Information Service (NTIS). NTIS is the central repository for scientific and
technical information generated by federally funded R&D projects, including
those in DHHS.
Other Mechanisms
Apart from formal Federal agency activities, mechanisms for dissemina-
tion include the public media, the mail, advertising, personal contacts, the
educational process, libraries, and other types of information centers. The
appropriateness of any of these mechanisms depends on whether the infor-
mation is to be used in assessing or marketing a medical technology. Print
media, radio, and television are primary channels to the public. In addi-
tion to carrying news about medical technologies and issues, they increas-
:This topic is to be explored at greater length in a separate OTA technical memorandum entitled
MEDLARS and Health Information Policy, to be published in fall 1982.
22
633
ingly tend to have health columns and special in-depth features about health
technologies. For more targeted audiences, mailings are used for solicited
and unsolicited information dissemination, for example, newsletters from
drug companies, advertisements from product distributors, and Federal lit-
erature. Advertising of drugs occurs in all media for the public and for health
professionals. A recently developed form of advertising, the video cassette,
is supplied to medical facilities. Personal contacts are an especially credi-
ble source of information exchange among health professionals. These often
occur formally and informally at professional meetings.
MAJOR CONCLUSIONS OF THE STUDY
In this study of medical technology assessment, OTA has reviewed the
evidence and concludes overall that there is no coherent system of assess-
ing medical technologies. There is, however, an urgent need for such a sys-
tem. The following are capsule statements of OTA's conclusions about the
adequacy of the present system with respect to the four stages of technology
assessment presented in figure 1: identification, testing, synthesis, and dis-
semination.
Identification
Emerging Technologies
OTA concludes that emerging drugs and devices are adequately and ap-
propriately identified, but that emerging medical and surgical procedures
could be better identified. Overall, however, the identification of emerg-
ing technologies for assessment is not a critical weakness of the present as-
sessment system.
New Technologies
OTA concludes that new drugs and devices are adequately identified for
the purposes of assessment, but that new medical and surgical procedures
are not. The most pressing need is for some routine mechanism, e.g., the
reimbursement system, to identify new procedures before they are widely
adopted. The reimbursement system may be the prime candidate, because
coverage and payment decisions are critical points in the diffusion of many
technologies. The priority-setting systems of the institutes of NIH and of
other Federal research agencies (e.g., NCHSR) are adequate and appropriate
for their respective mandates, but there is not an adequate similar system
to fulfill the needs of operating agencies (e.g., HCFA, planning agencies).
Finally, sufficient mechanisms of opportunity for identifying new technol-
ogies could be developed. Medical specialty societies could be helpful in
this area.
Existing Technologies
OTA concludes that the system for identifying existing technologies in
need of assessment is inadequate. The most promising possibility for iden-
tifying such technologies may be FDA's postmarketing surveillance of mar-
keted products. In the case of existing as well as new technologies, the
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priority-setting procedures of Federal research agencies may be adequate
for those agencies' respective needs; however, these procedures are not ade-
quate for the needs of operating agencies such as HCFA. And the operating
agencies themselves do not adequately identify existing technologies for
assessment. Medical specialty societies could be helpful in this area. Final-
ly, NCHCT's activities of identifying nationally important priority tech-
nologies for assessment were valuable but are not currently funded. Thus,
no organization is currently performing this important task.
New Applications of Existing Technologies
OTA concludes that new applications of existing technologies in need
of assessment are not adequately identified. The most promising approach
would seem to be the use of the reimbursement system to link the diagnosis
with the use of technology. Medical specialty societies could be helpful in
this area.
Testing
OTA concludes that, in general, drugs and devices are adequately tested
for safety and efficacy prior to being marketed. Medical and surgical pro-
cedures, which often include the use of drugs and devices within the prac-
tice of medicine, are not well tested for either safety or effectiveness. No
class of technologies is adequately evaluated for either cost effectiveness
or social and ethical implications. Finally, there is no organization whose
mission it is to ensure that medical and surgical procedures are assessed
for safety and efficacy or to evaluate medical technologies for cost effec-
tiveness and for social/ethical effects.
Synthesis
OTA concludes that the synthesis phase of the present system of tech-
nology assessment is unnecessarily weak, within both the private and public
sectors. Research evidence regarding the safety, efficacy, and effectiveness
from the use of medical technologies is seldom examined systematically and
objectively. Federal agencies and private insurers and organizations set
policies, guidelines, regulations, and/or make reimbursement coverage de-
terminations, many of which profoundly affect the adoption and level of
use of medical technologies. Yet, their decisions are usually based on in-
formal, subjective, group-generated norms which tend to support the status
quo. Formal, more objective techniques do exist, however, not only for
evaluating research evidence but also for making decisions and setting pol-
icy. These techniques could be used more often to aid in better
decisionmaking .
Dissemination
OTA concludes that better methods need to be found to communicate
information about medical technologies to health practitioners, health re-
searchers, and health policymakers.
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635
OTA also concludes that Government-generated research reports, many
of which may be important to technology assessment, are not as accessible
as they could be. Finally, NLM's mission and capabilities should be examined
to determine whether more Government reports and nonserial literature
should be included in its data base, and whether NLM should index ar-
ticles differently for researchers interested in technology assessments.
POLICY OPTIONS
The most important policy need is to bring forth a rational, systematic
approach from the present multiplicity of agencies and activities to pro-
mote and coordinate medical technology assessment. This could be accom-
plished in any of several ways. The options listed below are divided into
two broad categories: legislative and oversight. OTA finds that there are
relatively few realistic legislative options necessary for Congress to con-
sider, primarily because there is already substantial power invested in the
Secretary of Health and Human Services to develop a coherent system of
medical technology assessment. Thus, in most of the deficient areas noted
within this report, congressional oversight may be sufficient.
Legislative Options
1. Sponsor or grant a charter to a private/public organization to under-
take medical technology assessment activities.
2. Maintain the authority of, and appropriate funds for, NCHCT.
3. Change the statutes so that HCFA can selectively reimburse for ex-
perimental technologies in return for clinical data.
4. Increase funding to train researchers in methodological and statistical
principles.
5. Increase efforts to train health professionals in methodological and
statistical principles.
Oversight Options
6. Encourage the private sector to take the lead in assessing medical tech-
nologies.
7. Examine how Federal research institutes (e.g., NIH), agencies (e.g.,
NCHSR), and research programs of operating agencies within DHHS
could identify technologies better when setting research agendas; and
how the PSRO program and the reimbursement system could be used
to more advantage for identifying technologies for assessment.
8. Continue to conduct oversight hearings concerning the duplication and
fragmentation of health-related data collection activities.
9. Examine the ability of operating agencies within DHHS (e.g., HCFA)
to generate sufficient information for their own decisions related to med-
ical technologies, and examine the extent to which the Secretary of
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636
Health and Human Services utilizes the department's other research arms
(e.g., NCHSR, NIH) to procure that information in a timely manner.
10. Examine the activities, plans, and potential for elements of DHHS (e.g.,
NIH) in utilizing various research methods to determine the appropriate
use of medical technologies.
11. Explore how research evidence could be better evaluated by Federal
health agencies when recommending, setting, or implementing health
policy.
12. Examine the disposition of federally generated reports to determine how
accessible and useful they have been both to private and public research-
ers and policymakers.
13. Examine whether NLM should include more Government research re-
ports and other nonserial literature in its MEDLARS data bases.
14. Encourage use of the powers vested in the Secretary of Health and
Human Services to develop a coherent system of medical technology
assessment.
NOTE: Copies of the full report "Strategies for Medical
Technology Assessment," can be purchased from the
Superintendent of Documents, U.S. Government Printing Of-
fice, Washington, D.C. 20402, GPO stock No. 052003-00887-4.
26
637
Mr. Gore. I would like to thank you for your testimony here
today, too, Dr. Banta. Thank you very much.
Dr. Banta. Thank you very much.
Mr. Gore. Now, our final panel is a large panel. I would like to
ask them to come to the witness table, and we will get some addi-
tional chairs if necessary.
Dr. Jeffrey Prottas, visiting professor at the Center for Health
Policy Analysis and Research at Brandeis; Dr. Richard Rettig, pro-
fessor and chairman of the Department of Social Sciences at the
Illinois Institute of Technology in Chicago; Dr. Peter Safar, univer-
sity professor at the University of Pittsburgh Resuscitation Re-
search Center; Dr. Kenneth W. Sell, founder and past president of
the American Association of Tissue Banks; and Winifred B. Mack,
president of NATCO at Stony Brook in the Department of Surgery
of Long Island. NATCO, of course, is the North American Trans-
plant Coordinators Organization, and we are happy to have Wini-
fred Mack join us today.
Without objection, as I stated earlier, all of your prepared state-
ments will be included in the record in full.
We will start with Dr. Kenneth W. Sell, founder and past presi-
dent of the American Association of Tissue Banks in Rockville, Md.
Dr. Sell, welcome and please proceed.
STATEMENT OF KENNETH W. SELL, M.D., PH. D., AMERICAN
ASSOCIATION OF TISSUE BANKS
Dr. Sell. Thank you, Mr. Chairman.
I am pleased to appear before you and the committee to talk
about these important issues.
The American Association of Tissue Banks was established spe-
cifically to deal with a broad range of interests and issues related
to tissue procurement and preservation.
The objectives of this organization have been to promote scientif-
ic and technical research and knowledge regarding both the donor
procurement and collection as well as the processing and storage
and transplantation of all forms of transplants, including cells, tis-
sues, and organs.
We have also been trying to encourage voluntary donation of
organs and tissues and to encourage the development of regional
tissue banks to provide these materials in a safe and adequate and
economical supply.
The advances that we have read about in the literature and
heard at this committee meeting have shown us that we have a
new wave of transplantation upon us. In large part, we have heard
that this reflects improvements in immunosuppressive techniques
such as the use of cyclosporin.
What is perhaps not fully appreciated is that immunosuppression
even with cyclosporin is only a stage in the development of the
transplantation issue. It still represents a nonspecific immuno-
suppressive agent which does have side effects, as all nonspecific
immunosuppressive agents have.
That does not mean that cyclosporin is not a significant, impor-
tant, and very valuable contribution to transplantation. But we
must realize that research is currently ongoing that within the
23-029 0-83-41
638
next decade lead to complete abolition of graft rejection, either
through treatment of the graft by eliminating stimulating leuko-
cytes or through pretreatment of the recipient to induce tolerance,
just as a mother induces to her own child that does not reject it.
At the present time, the number of candidates for organ trans-
plantation is limited in part, at least, by the capacity of the recipi-
ent to tolerate the various immunosuppressive regimens that are
available. Because of the risks involved, organ transplants are usu-
ally limited, therefore, to those for whom ^ is a life-saving
procedure.
The prevention of graft rejection and the elimination of the need
for immunosuppression will ultimately make transplantation feasi-
ble for the treatment of non-lethal conditions and will vastly in-
crease both the number of candidates for transplants and the va-
rieties of organs and tissues to be transplanted. We must look
ahead to an explosive increase in demand for organs and tissues.
The dramatic, life-saving nature of organ transplants has often
obscured the fact that a variety of other tissues are now used suc-
cessfully in reparative surgery in patients with a wide variety of
clinical conditions. These tissues are generally preserved by freeze-
drying and are nonviable. They provide structural support and
serve as matrices for repopulation of host cells.
For example, less spectacular to the public, although not to the
patient, is the removal of an osteosarcoma, a bone tumor, with its
replacement by a cadaver joint or bone graft. Such patients in the
past routinely required amputation in order to effectively and com-
pletely remove the bone tumor.
Now, through the pioneering work of surgeons such as Dr. Henry
Mankin of Harvard, it is often possible to remove the tumor and
replace the neoplastic tissue with normal allograft cadaver bone.
There are over 40,000 bone transplants done in this country each
year in which bone is taken from one part of the body and used in
another. Each of these could be considered for allograft bone trans-
plantation if sufficient donor tissue were available.
We already know that corneal transplants are used widely since
the first eye banks were established in 1944. Restoration of sight,
while not lifesaving, is a significant personal event.
Other transplantable tissues include tendons, cartilage, heart
valves, fascia, dura, arteries, nerves, bones of the inner ear and
skin. Skin is used primarily for the treatment of burn patients as a
temporary dressing, allowing them to survive until their own skin
can be used for definitive covering.
In order to successfully and adequately deal with the national
transplantation program, both the public and the scientific and
medical professions must engage in a cooperative effort. Individual
citizens are ultimately the source of donor material, and we must
develop a national awareness of the critical importance of organ
and tissue donation as a civic and humanitarian responsibility.
However, perhaps equally or more important is cooperation
within the medical profession. Each tissue and organ has its own
protagonists, working diligently to develop the most successful
transplant schemes possible to provide the best medical care for
their patients.
639
However, surgeons and others involved in cell, tissue, and organ
transplantation must also recognize that all tissue comes from a
common donor source. If we are to maximize the availability of tis-
sues and organs, we must not unduly emphasize the importance of
one versus the other.
Without question, those lifesaving procedures requiring organs
that can be stored for only a few hours must deserve top priority.
However, it is notable that in many communities, the eye bank,
the skin bank, the bone bank, and the kidney transplant bank may
seek independently to obtain tissues or organs necessary to meet
the needs of their clinical specialty.
On the other hand, we have excellent examples recently being
developed of cooperation in various cities such as Baltimore,
Miami, St. Louis and San Francisco, where the various groups of
specialized surgeons and transplantation organizations are working
together.
We would appreciate your committee's efforts to ensure that the
Federal Government supports, but does not bias, the development
of this cooperative regional effort to collect tissues and organs.
Preferential funding of transplantation of a particular organ could
lead to an undue emphasis which might preclude or at least inter-
fere with the procurement of other valuable tissues.
On the other hand, support for regional procurement facilities
allows the altruistic and enlightened physicians to join with their
colleagues in providing an expanded source of donor material for
all types of transplantation.
We must encourage the private sector to develop regionally coop-
erative tissue and organ collection and preservation systems and
programs. The rapidly accelerating success of tissue transplanta-
tion for the treatment of serious and lethal human diseases will in-
evitably result in a critical shortage unless this cooperative is
achieved.
We therefore recommend several items to be considered: First,
that this committee and the public in general recognize the total
need for transplant tissues in the treatment of both debilitating as
well as lifesaving conditions.
We should develop a nationally coordinated program of public
education and a large-scale enlistment of individuals committed to
donating their organs and tissues at the time of death.
We should facilitate and optimize the methods by which suitable
donors are identified in order to maximize the supply of tissue. In
this regard, by the way, we heartily applaud the Surgeon General's
conference which deals specifically with this issue.
We should try to balance our enthusiasm and support to insure
that all forms of transplantation receive the necessary priority for
donor collection and transplantation.
We should foster the efforts of the private sector to develop re-
gional cooperation in the collection and preservation of tissues and
organs. We would urge the implementation of the centers for dis-
ease control pilot program for regional hospital cooperation in the
identification of donors through regional tissue and organ banking
systems.
And finally, we would suggest that all private sector societies, or-
ganizations, research groups, and clinical associations should indi-
640
vidually contribute to the effort to identify suitable donors at the
time of death. These groups should make information available on
the full array of tissues and organs that might be suitable for rep-
arative and life-saving surgery, and not restrict their efforts to pa-
rochial interests.
Mr. Chairman, I thank you for the opportunity to address the
committee on these important issues.
[The prepared statement of Dr. Sell follows:]
641
TESTIMONY
by
KENNETH W. SELL, M.D., Ph.D
American Association of Tissue Banks
Mr. Chairman and Members of the Subcommittee:
I am pleased to appear before you to discuss the goals and the commitment of
the American Association of Tissue Banks. I am Dr. Kenneth W. Sell, Past
President and present member of the Executive Committee of the American
Association of Tissue Banks. This testimony reflects both my views and those
of Dr. Harold T. Meryman, current President of the American Association of
Tissue Banks.
The objectives of the American Association of Tissue Banks are to promote
scientific research and technical knowledge regarding the procurement,
processing, storage, transplantation, and evaluation of 'cells, tissues and
organs for clinical and research uses; to encourage voluntary donation of
these materials; to encourage the development of regional tissue banks to
provide a safe, adequate and economical supply of cells, tissues and organs;
and to establish guidelines and standards for their collection, preservation
and distribution. The Association consists of individual as well as
institutional members.
During these hearings, we have heard and been moved by the appeals of those
who are concerned with the transplantation of whole living organs,
particularly the liver. Patients, their families and their physicians have
all expressed their desire to extend the availability of liver transplants,
particularly for the correction of hepatic birth defects. The plaintive
appeal of the infant must be answered. We understand that the Public Health
642
Service will shortly be holding a consensus development conference which
should permit a valid analysis of the current clinical applicability of liver
transplantation in this country. In addition, we are also aware of the
improved success of other organ transplants, particularly of kidneys. Several
thousand lives are being saved each year because of the success of this
technology.
These advances reflect, in large part, improvements in immunosuppressive
techniques, especially the use of Cyclosporin A. What is perhaps not fully
appreciated is that immunosuppression, even with Cyclosporin, is only a stage
of development and that current research in transplantation immunology may, in
only a few years, lead to the complete abolition of graft rejection, either
through treatment of the graft to eliminate stimulating leukocytes or through
pretreatment of the recipient to induce tolerance, just as a mother develops
tolerance to her phenotypically different fetus.
At the present time the number of candidates for organ transplant is limited
by the capacity of the recipient to tolerate the immmunosuppressive regimen.
Because of the risks involved, organ transplants are limited to those for whom
it is a lifesaving measure. The prevention of graft rejection and the
elimination of the need for immunosuppression will make transplantation
feasible for the treatment of non-lethal conditions and will vastly increase
both the number of candidates for transplants and the variety of organs and
tissues to be transplanted. We must look ahead to an explosive increase in
demand.
643
The dramatic, life-saving nature of organ transplants has often obscured the
fact that a variety of other tissues are now used successfully in reparative
surgery in patients with a wide variety of clinical problems. These tissues
are generally preserved by freeze-drying and are non-viable. They provide
structural support and serve as matrices for repopulation by host cells. Of
particular value is the fact that freeze-drying destroys the capacity of these
tissues to stimulate rejection and no immunosuppressive therapy is required.
For example, less spectacular to the public, although not to the patient, is
the removal of an osteosarcomatous bone tumor with replacement by cadaver
joint or bone. Such patients, in the past, routinely required amputation in
order to effectively and completely remove the tumor. Now through the
pioneering work of Dr. Henry Mankin at the Massachusetts General Hospital in
Boston, it is often possible to remove the tumor and replace the neoplastic
tissue with normal allograft cadaver bone. Over 40,000 bone grafts using bone
from elsewhere in the patient are done each year. Each of these could be
considered for allograft bone transplantation if sufficient donor tissue were
available. We already know that corneal transplantation has been highly
successful since the first eye banks were established in 1944. Restoration of
the sight, while not lifesaving, is a significant personal event.
Other transplantable tissues include tendons, cartilage, heart valves, fascia,
dura, arteries, nerves, the bones of the inner ear and skin. Living skin is
commonly used as a covering for extensive burns. It provides a living cover
644
for the bum for four to six weeks until it is rejected, by which time the
patient has stabilized and grafts from unburned areas can be applied.
Although there are some synthetic coverings that are also used in burn
therapy, the future abolition of graft rejection will mean that skin
transplants will be permanent and far more desirable than other temporary
coverings. Demand will increase many-fold.
In order for a successful and adequate national transplantation program to
develop, both the public and the scientific and medical professions must
engage in a cooperative effort. Individual citizens are ultimately the source
of donor material and we must develop a national awareness of the critical
i
importance of organ and tissue donation as a civic and humanitarian
responsibility. Cooperation within the medical profession is equally vital.
Each tissue and organ has its own protagonists, working diligently to develop
the most successful transplant schemes possible to provide the best medical
care for their patients. However, surgeons and others involved in cell,
tissue and organ transplantation must also recognize that all tissues come
from a common donor source. If we are to maximize the availability of tissues
and organs, we must not unduly emphasize the importance of one versus
another. Without question, those lifesaving procedures requiring organs that
can be stored for only a few hours deserve top priority attention. However,
_it is notable that in many communities the eye bank, the skin bank, the bone
bank and the kidney transplant organ procurement agency seek independently to
obtain the tissues necessary to meet the needs of their clinical specialty.
On the other hand, we do have excellent examples of cooperation between tissue
645
procurement activities. The Medical Eye Bank of Baltimore, for instance,
working closely with the local community, is currently developing plans to
facilitate organ donation. The St. Louis Red Cross Blood Center is currently
engaged in an effort to coordinate organ, tissue and bone marrow procurement
groups, in addition to procuring bone and corneas.
We would appreciate your Committee's effort to ensure that the Federal
Government supports but does not bias the development of cooperative regional
efforts to collect tissues and organs. Preferential funding of
transplantation of a particular organ could lead to an undue emphasis which
might preclude, or at least interfere with the procurement of other valuable
tissues. On the other hand, support for regional procurement facilities
allows altruistic and enlightened physicians to join with their colleagues in
providing an expanded source of donor material for all types of
transplantation. We must encourage the private sector to develop regionally
cooperative tissue and organ collection and preservation programs. The
rapidly accelerating success of tissue transplantation for the treatment of
serious and lethal human diseases will inevitably result in a critical
shortage unless such cooperation is achieved.
I would suggest that this Committee and those who attend these hearings should
^consider the following:
1. We should recognize the total need for transplantable tissues for the
treatment of both reparative and life-threatening illnesses.
646
2. We should 'develop a nationally coordinated program of public education
and large-scale enlistment of individuals committed to donating their
organs and tissues at the time of death.
3. We should facilitate and optimize the methods by which suitable donors
are identified in the hospital to maximize the supply of tissues and
organs.
4.
We should try to balance our enthusiasm and support to ensure that all
forms of transplantation receive the necessary priority for donor
collection and transplantation.
5. We should foster the efforts of the private sector to develop regional
cooperation in the collection and preservation of tissues and organs. We
would urge the implementation of the Centers for Disease Control pilot
program for regional hospital cooperation in the identification of donors
through regional tissue and organ banking systems.
6. All private sector societies, organizations, research groups and clinical
associations should contribute to the effort to enlist organ donors, to
identify suitable donors at the time of death and to make information
available on the full array of tissues and organs that may be suitable
for reparative transplantation surgery.
Mr. Chairman, I thank you for the opportunity to address
the Committee on this very important issue.
647
Mr. Gore. Thank you very much.
We will hold our questions until the panel has concluded.
Our next witness is Dr. Peter Safar, university professor at the
University of Pittsburgh Resuscitation Research Center.
Dr. Safar, am I pronouncing your name right?
Dr. Safar. Yes, you are.
Mr. Gore. Good; welcome, please proceed.
STATEMENT OF PETER SAFAR, M.D., UNIVERSITY PROFESSOR
AND DIRECTOR OF RESUSCITATION RESEARCH CENTER, UNI-
VERSITY OF PITTSBURGH
Dr. Safar. Since I am not a transplant surgeon, not a transplant
organizer, and not an administrator, I have no vested interest with
this testimony.
I believe I am here because I am engaged full time in the re-
search on acute dying processes and resuscitation and because my
associates and I developed America's first physician-staffed inten-
sive care unit, and critical care involving training programs, and
did research which coinitiated cardiopulmonary resuscitation,
brain resuscitation, and orderly brain death certification.
The latter was pioneered by my associate, Dr. Grenvik, who, to
my knowledge, was the first one to implement these procedures in
the USA in an orderly fashion. In 1968, soon after the Harvard cri-
teria for brain death certification were published, a local commit-
tee in Pittsburgh at the same time spelled out such criteria for im-
plementation.
I have some personal experience with the occurrence of brain
death and organ donation in my own family. In 1966, my 12-year-
old daughter, a chronic asthmatic, asphyxiated to cardiac arrest, in
her parents' absence. The heart was restarted, but, her brain re-
mained dead. In order to add meaning to her life and death and to
help change the then unsound practices of non-heart-beating cadav-
er kidney transplants, I gave permission — to my knowledge, for the
first time — for the removal of organs before cessation of heartbeat
and the discontinuation of mechanical ventilation.
Some comments about recipients. For end-stage renal failure,
about 62,000 patients are presently on chronic dialysis in this coun-
try. About 5,000 patients received kidney transplants last year in
the USA, in spite of the fact that transplants are more cost effec-
tive than dialysis.
In Sweden, about 600 patients are on chronic renal dialysis,
while almost the same number received kidney transplants in 1
year. The difference between these two countries' ratios is attribut-
ed to our country's economic incentives for dialysis.
You are aware of the fact that my colleagues in Pittsburgh, Drs.
Bahnson, Starzl, and Hakala, are very active in transplanting
hearts, livers, and kidneys. Even the very daring heart-lung combi-
nation transplant has been tried there, with 2 out of 4 patients ap-
parently now well at home.
The kidney transplantation procedures, in my opinion, have
become an important part of general lifesaving medicine. This will
soon be followed by heart, liver, and heart-lung transplants getting
this kind of ranking, which, however, at the present time, we
648
should consider innovative therapy. I am deliberately differentiat-
ing between innovative therapy, experiments, and research. Not all
research is experimental. One should pay through public funds and
insurances for innovative therapy. But one should do this in special
centers where research can be conducted at the same time.
There has been much said today about whether transplant sur-
gery is experimental or not. Almost every management of a criti-
cally ill or injured patient is an experiment. The results of the
Pittsburgh group ranged between 50 and 60 percent of the heart
and liver transplant patients having survived without organ rejec-
tion for up to 1 year or more.
We should look into the future. Once the immune rejection prob-
lem is solved, the need for multiorgan donors may increase to
50,000 or 100,000 per year in the U.S.A. About 50 percent of the
62,000 patients with end-stage renal failure now on dialysis,
namely 30,000, are estimated to be suitable recipients. The number
of candidates for heart transplants may become even greater in the
future. Transplantations of hearts can be expected to mushroom
once the operative mortality and rejection rate drops below about
20 percent. I fully agree that Cyclosporin has been only a halfway
breakthrough, and that we are still far from the solution of the re-
jection problem.
Most likely, artificial heart devices will prove to be effective for
temporary artificial circulation, while the patient with a failing
heart is being evaluated as to the recuperability of his own heart
or suitability for transplantation. Transplanted hearts seem to
adapt better than presently available artificial hearts to changes in
functional demands. Heart transplants and liver transplants al-
ready give a fair chance for return to good quality of life.
It is very important to assess benefits in terms of quality and du-
ration of survival, not merely in terms of mortality, and to assess
the therapies we are talking about in terms of "appropriateness,"
not so much whether it is experimental therapy or not.
Transplantation surgery should receive public funding, but with
consideration of other still-unmet health care needs nationwide. It
is nice to be concerned about one child here and another one there.
But let's face facts. We have not given high priority to measures
which might be more cost effective, such as control of malnutrition,
death, and crippling from trauma and infectious diseases; preven-
tion of atherosclerosis; and many others. Our resources are finite.
Some comments about donors. Transplantation of viable organs
requires procurement of organs from brain-dead cadavers with the
heart kept beating by a breathing machine. To meet the above-
mentioned needs, methods will have to be found to increase the
procurement of organs suitable for transplantation.
In recent years, organs were procured from only about 2,500
brain-dead donors per year in the U.S.A. The estimated maximal
number of brain-dead donors presently available seems to be
around 20,000 per year.
Certification of brain death is now possible with a safe and order-
ly process and a 100-percent reliability. This process, however, is
not always followed, as illustrated by an occasional patient in the
past transferred to our hospital for organ transplantation with the
outside diagnosis of brain death, in whom the prescribed orderly re-
649
examination revealed that he was not brain dead, and continued
life support resulted in recovery.
There also seem to be physicians who, because of not wanting to
be bothered or because of fear of malpractice suits, shy away from
initiating brain death certification and rather let nature take its
course. This is costly. Therefore, an educational campaign for
health professionals is indicated.
Voluntary donation by family members has posed no major prob-
lems in Grenvik's experience. The majority of families approached
at the time of brain death certification considered organ donation a
positive act, to give the life and death of the deceased additional
meaning. These positive feelings were seen in spite of shock and
grief.
Nevertheless, about 1 of 5 families of potential donors ap-
proached by others have refused donation. Hesitancy on the part of
primary physicians to approach the family during shock and grief,
when he the physician has a feeling of failure in the face of the
patient's demise, understandably adds to a low organ procurement
rate.
Donor cards have not been the answer. Sigmund Freud said that
our own death is indeed unimaginable, so people prefer not to plan
for it.
We might increase the number of available donors by medicare
reimbursement schemes and by Joint Commission of Accreditation
of Hospitals requirements as well as State hospital accreditation
requirements changes, particularly to facilitate the brain death
certification procedure and to facilitate the transfer of heart-beat-
ing cadavers with mobile intensive care unit ambulances to trans-
plantation centers.
But all this might be simpler with "presumed consent for autop-
sy and organ donation." It is interesting that in Austria, already in
the 1700's, a law was introduced by the Emperor which enabled
doctors to perform autopsies on patients who died in hospitals, to
determine the cause of death and enhance scientific knowledge,
without having to ask for consent.
This presumed consent for autopsy, as you know, has recently
been extended to presumed consent for organ donation, in Austria,
Czechoslovakia, Denmark, France, Israel, Poland, and Switzerland.
There is a trend that other European countries will follow, as pre-
sumed consent has been recommended by the European Committee
on Legal Cooperation, which is equivalent to our National Confer-
ence on Uniform State Laws. The family can object. This, in the
case of the above-mentioned countries, has happened very rarely.
In my opinion, automatic permission for hospital physicians to
carry out autopsies and organ donation without having to first so-
licit consent from the family, would facilitate measures which are
in the public interest, but may cause a backlash in this country,
because of our deeply rooted voluntarism. Before embarking on a
promotion of presumed consent legislation, it may be wise to carry
out an opinion poll to assess such a backlash, which would result in
increased public refusal of organ donation.
Organ preservation at the present time is in a very primitive
state. Research is needed and should be funded. If organs removed
from heart-beating cadavers could immediately be plugged into an
650
effective, not-yet-developed preservation system which would keep
them alive for up to 1 week, one could not only make use of per-
haps 20 percent more organs than is now the case from presently
available donors, but also reduce the cost and manpower drained
away from other parts of medical care. Improved organ preserva-
tion would change these now-emergency transplant operations into
planned elective procedures.
And finally, a comment on cerebral death— neocortical death—
which must be differentiated from brain death. Cerebral death—as,
for example, in the case of Karen Quinlan— is a condition in which
the higher thinking centers of the brain are destroyed, but mid-
brain, cerebellum, and medulla may still partially be active. These
patients may breathe spontaneously, do not show some other signs
of brain death, but are unresponsive, and have no chance to recov-
er human mentation.
Biomedical ethics, in my opinion, should not only equate brain
death but also cerebral death, namely persistent vegetative state—
with emphasis on proven persistence— with death. This, then,
would create not only heart-beating but also naturally breathing
Neither medicine nor society is ready to include patients with ce-
rebral death among potential transplant organ donors. From a
medical, scientific, and ethical point of view, however, the only
missing link is the documentation process. Often it is not possible
to prove with 100 percent certainty that the vegetative state diag-
nosed is irreversible. This has to be researched.
Since cerebral death develops more slowly, one would have to
wait for up to 1 month after a head injury and at least 1 to 2 weeks
after cardiac arrest, before one can clinically determine the irre-
versibility of such a state.
Much research is needed (and should be funded by the National
Institutes of Health) on the documentation of the irreversibility of
cerebral death, and the methods which might be considered for
organ removal from heart-beating and breathing cadavers. The
time for including cerebral death victims among potential organ
donors has not yet come. . .
In summary, first, organ transplantation should receive priority
as one among many vital health care needs of the Nation.
Second, regional programs and legislation should facilitate pro-
curement of organs to be matched with needs, more so than with
perceived demands.
Third, plans should now be made for the time when the immune
rejection problem will have been solved by ongoing research.
Fourth, one mechanism for increasing organ procurement is mo-
tivating physicians, particularly intensive care physicians.
Fifth, brain death certification should be enhanced by appropri-
ate changes in reimbursement and hospital accreditation require-
ments.
Sixth, presumed consent, although desirable, shall first have
public opinion consent by a poll.
Seventh, research into the preservation of donor organs should
be fostered and funded.
Eighth, research into the cerebral death determination should be
fostered and funded.
651
Thank you.
[The prepared statement and attachments of Dr. Safar follows:]
Testimony by Peter Safar, M.D., University Professor and Director of
Resuscitation Research Center, University of Pittsburgh
Testimony by Peter Safar
Hearings on Procurement and Distribution
of Human Organs for Transplantation
Subcommittee on Investigations and Oversight
Committee on Science and Technology
U.S. House of Representatives
April 27, 1983
INTRODUCTION
My name is Peter Safar. I am a physician, "Distinguished Service Professor
of Resuscitation Medicine," and Director of the Resuscitation Research Center of
the University of Pittsburgh. I am engaged almost fulltime in research on acute
dying processes and their reversibility. Our research programs are in the
laboratory, with patients, and in the community. I was the initiator and
chairman of the Department of Anesthesiology and Critical Care Medicine at the
University of Pittsburgh and before that, Chief Anesthesiologist at the Baltimore
City Hospitals, where my associates and I developed America's first physician-
staffed medical-surgical intensive care unit. In Pittsburgh, my associates and I
started in 1963 the first critical care medicine physician fellowship training
program, and in 1979 the western world's first multidiscipl inary Resuscitation
Research Center. I was founding member and president of the Society of Critical
Care Medicine; and member of the White House Interagency Committee and the
National Research Council Committee on Emergency Medical Services, the first
American Heart Association Committee on Cardiopulmonary Resuscitation,* and
other standard setting groups at state, national and international levels,
concerning anesthesiology, resuscitation, emergency care and critical care
(intensive care). My associates and I have been credited with the research which
led to the teaching of mouth-to-mouth resuscitation, and co-initiated cardio-
pulmonary resuscitation and brain resuscitation. The latter includes studies of
brain death and vegetative state.
In addition to my professional activities, I have personal experience with
the occurrence of brain death and organ donation in my own family. In June 1966,
my 12 year old daughter Elizabeth, a chronic asthmatic, asphyxiated to cardiac
arrest, in her parents' absence. The heart was restarted but her brain remained
dead. In order to add meaning to her life and death and to help change the then
unsound practices of cadaver kidney transplantation, my wife and I gave permis-
sion (to my knowledge for, the first time) for transplant surgeon Dr. Bernard
Fisher to remove organs from my daughter's brain dead body, before the cessation
of heart beat and the discontinuation of mechanical ventilation. Elizabeth's
life and death obviously influenced my work in intensive care medicine and
resuscitation research, as well as this testimony.
In 1968, coincident with the publication of the Harvard criteria for brain
death certification, a local committee in Pittsburgh spelled out criteria and
mechanisms for brain death determination. My associate, Dr. Ake Grenvik,
Professor of Anesthesiology and Surgery and Director of Critical Care Medicine at
the University of Pittsburgh, and I served on this committee. Soon thereafter,
Dr. Grenvik was, to my knowledge, the first one to implement these procedures in
the USA in an orderly fashion (see enclosures). His work on organ procurement in
652
the intensive care units of the University Health Center of Pittsburgh, particu-
larly at Presbyterian-University Hospital, for over 10 years, pioneered this
field. His group has continuing experience not only with procurement of kidneys,
but also with heart, lung, liver and pancreas transplantation. My associates and
I have been advisors for the guidelines for the Determination of Death (JPm
246-2184 1981) and Management of the Permanently Unconscious Patient, which were
recently developed by the President's Commission for the Study of Ethical
Problems in Medicine and Biomedical and Behavioral Research. I also served
recently on a panel of 10 physicians, who met in Boston under the auspices of the
Society for the Right to Die, and who established guidelines for the management
of hopeless, terminally ill patients, including the "letting die" of patients in
persistant vegetative state (in preparation for publication).
Since I am not a transplant surgeon, I have no vested interests. My
testimony will reflect my personal knowledge, attitudes and values, based on
experiences with patient care, teaching, research, administration and program
initiation in anesthesiology, resuscitation, emergency care and intensive care.
My testimony is further influenced by my continuing professional relationships
with my associate Dr. Grenvik (enclosures); Mr. Donald Denny, Director of
Western Pennsylvania's organ procurement program; two transplant surgeons; and
two forensic pathologists.
653
RECIPIENTS
For end stage renal failure, about 62,000 patients are presently on
dialysis; about 5,000 patients received kidney transplants last year in the USA.
Transplants are more cost effective than dialysis. In Sweden about 600 patients
are on chronic renal dialysis while 500 received kidney transplants in one year.
The difference between these two countries' ratios is attributed to our country's
economic incentives for dialysis. This example demonstrates the importance of
establishing true needs rather than merely reacting to demands. Since the
introduction of cyclosporine for suppression of the immune rejection of trans-
planted organs in 1980, about 100 kidneys per year are transplanted at the
Presbyterian-University Hospital in Pittsburgh, with an over 80% graft survival
rate; 94% of the patients survived. Pittsburgh has also become a center for
heart and liver transplantations. Until now, about 40 hearts have been trans-
planted, with about 65% short-term patient survival. Projected long-term graft
survival is estimated as 50%. Two of the 4 heart- plus-lungs transplant
recipients of Pittsburgh (and 6/12 at Stanford) are at home. In the past two
years, 88 patients received liver transplants (some of them more than one), with
55% up to one year survivors. These data suggest that kidney transplantation,
which has become an important part of general life saving medicine, may soon be
followed by heart, liver and heart-lung transplantations, which are still to be
considered innovative therapy, or research.
Once the immune rejection problem is solved, the need for multi-organ donors
may increase to 50-100,000 per year in the USA. While about 50% of the 62,000
patients with end stage renal failure now on dialysis, i.e., 30,000, are
estimated to be suitable recipients. The number of candidates for heart
transplants may become even greater. Transplantations of hearts can be expected
to mushroom once the operative mortality and rejection rate drops below about
20%. Most likely, artificial heart devices will prove to be effective more for
temporary artificial circulation while the patient with a failing heart is
evaluated as to the recuperabi lity of his own heart, or is being considered for
transplantation. Transplanted hearts seem to adapt better than presently
available artificial hearts to changes in functional demands. Heart transplants
already give a chance for return to a high quality of life.
While transplantation of kidneys should compete with other general health
care priorities, transplantations of hearts, lungs and livers are still in the
realm of experimentation, and therefore should be carried out in a few centers
only, which are specially funded for coordinated multidi scipl inary research.
Transplantation surgery which becomes general medical care, such as kidney
transplants, should receive public funding but with consideration of other still
unmet health care needs nationwide. Setting priorities for expensive health care
programs requires data and dialogue between the medical profession and the lay
public. High priority must be given to cost effective preventive measures
against life threatening illness or injury, and to programs which combat malnu-
trition, neonatal mortality, atherosclerosis, sudden cardiac death, infectious
diseases and death and crippling from trauma. Resources are always finite.
Costs should be measured in terms of years of survival gained. Assessment of
benefits should include quality of survival.
23-029 0-83-42
654
DONORS
Because of the sensitivity of vital organs to a reduction in the supply of
oxygen and nutrients, the transplantation of viable kidneys, hearts, lungs,
livers, pancreases, etc., requires procurement of organs from brain dead cadavers
with the heart kept beating by breathing machine. To meet the above mentioned
need for 50-100,000 multi-organ donors per year in the near future, methods will
have to be found to increase the procurement of organs suitable for transplanta-
tion. In recent years, organs were procured from only about 2500 brain dead
donors per year in the USA. The estimated maximal number of brain dead donors
presently available is about 20,000 per year in the U.S.A. This estimate is
based on about 2% of the 1 million deaths which occur each year in our nation's
hospitals (another 1 million deaths per year occur outside hospitals). At
present only an estimated 5,000 patients received organ transplantations last
year in the U.S.A. In 1981, 3,400 kidneys were transplanted, while 6,000
patients are on waiting lists. This figure should be higher considering the
estimated 30,000 suitable candidates for kidney transplantation. Methods have to
be devised to increase the number of donors and to make maximal use of available
donor organs.
Present organ procurement. In most major medical centers with advanced
intensive care units patients who develop brain death (e.g., from trauma, oxygen
lack, stroke, tumor) are managed as recommended (see references). This includes
a detailed orderly determination of brain death according to clearly spelled out
criteria, certification of brain death by two physicians not of the transplant
team, obtaining of consent from the next of kin to remove organs for trans-
plantation, and finally operative removal of organs from the heart beating
cadaver prior to discontinuing the ventilator. This safe and orderly process is
not always followed in some community hospitals, as illustrated by an occasional
patient in the past transferred to our hospital for organ transplantation, with
the diagnosis of brain death, in whom the prescribed orderly examination revealed
that he was not brain dead, and continued life support resulted in recovery.
There also seem to be physicians who because of not wanting to be bothered or
because of fear of malpractice suits, shy away from initiating brain death
certification and rather let nature take its course. Most (but not all) brain
dead patients on artificial ventilation develop intractable decrease in blood
pressure and heart arrest occurs within 1 week while artificial breathing is
continued. Such practice should be discouraged, since it not only deprives
others of viable organs, but also adds unnecessarily to intensive care costs.
Therefore, an educational campaign for health professionals is indicated.
Voluntary donation by family members has, in the experience of Grenvik's
group at Pittsburgh, posed no major problems. The majority of families
approached at the time of brain death certification have considered organ
donation a positive act, to give the life and death of the deceased additional
meaning. These positive feelings were seen in spite of shock and grief.
Nevertheless, about 1 of 5 families of potential donors' approached by others
have refused donation. Hesitancy on part of primary physicians to aporoach the
family during shock and grief, when he the physician has a feeling of failure in
the face of the patient's demise, understandably adds to a low organ procurement
rate.
655
The carrying of donor cards has not been effective since "our own death is
indeed unimaginable" (Freud) and people prefer not to plan for it. Education of
physicians, particularly those controlling brain death certification in inten-
sive care units, has been effective but should be intensified to include those
responsible for the care of ICU patients in community hospitals. Financial
incentives given by Medicare reimbursement schemes and requirements of hospital
accreditation boards for orderly brain death determination would help in the
procurement of a greater number of organs from brain dead potential donors in not
only transplant hospitals, but the majority of hospitals nationwide. There
should be increasing consideration given to the transfer of heart beating
cadavers to transplantation hospitals for multiple organ procurement. This donor
transfer is needed for heart and lung transplants, since the lungs must be
transplanted within one hour. Transfer would have to be carried out by mobile
ICU ambulances staffed with paramedics under physician direction—covered by
health insurance.
Presumed consent for autopsy and organ donation. Historically, Emperor
Joseph II of Austria in the l/00s established a law (which still prevails in
Europe) which enables doctors to perform autopsies on patients who die in
hospitals, to determine the cause of death and enhance scientific knowledge,
without asking for consent. The patient's relatives, however, could refuse,
which very rarely happened. This presumed consent for autopsy was used widely by
European medical researchers since the mid-1800s for pioneering great advances in
medicine. In my own efforts to improve emergency medical services in the U.S.A.,
I have frequently been frustrated by the inability to determine the cause of
death and the potential salvagabi lity of a victim of acute illness or injury.
Autopsies are needed for quality control of care and for gaining new knowledge to
advance the therapeutic potentials of medicine. In the U.S.A., only in cases of
suspected mishaps or a wrong doing will the medical examine*- or coroner get
involved; only he may use implied consent for autopsy. In some states this
includes implied permission to remove eyes or other organs from the cadaver. For
transplantation, the general health of donors should be established by autopsy.
The operation of organ removal in a way represents a partial autopsy while the
heart is beating. Transplantation would benefit from at least giving medical
examiners automatic permission to remove organs, and to delegate autopsies and
organ removal to the hospital.
Presumed consent would probably be an effective mechanism to overcome
inertia and increase organ procurement. It is possible that in the U.S.A. such
presumed consent legislation would be declared unconstitutional. The presumed
consent for autopsy has in recent years in some European countries been expanded
to a presumed consent for organ donation. A recent review (Stuart, et al . )
revealed that these countries include Austria, Czechoslovakia, Denmark, France,
Israel, Poland and Switzerland. There is a trend that other European countries
will follow, as presumed consent has been recommended by the European Committee
on Legal Cooperation (equivalent to our National Conference on Uniform State
Laws). In my opinion, automatic permission for hospital physicians to carry out
autopsies and organ donation (unless the family objects) without having to
solicit consent from the family, would facilitate measures which are in the
public interest, would advance knowledge for improving life-saving measures,
would permit use of donor organs to keep others alive, and would merely represent
a generalization of the already existing regulations under which medical
examiners and coroners function in this country. Because of the deeply rooted
voluntarism in the U.S.A., hov/ever, before embarking on a promotion of presumed
consent legislation, it may be wise to carry out an opinion poll to prevent a
backlash, which could result in increased public refusal of organ donation.
656
Improved organ preservation. The present method used for preventing death
of organs removed from heart beating cadavers during waiting for and transfer to
an appropriately matched donor (who may not be in the same hospital) consists of
once flushing the vessels of the organ with a cold plasma substitute solution,
and then putting the organ into a solution containing ice, without further organ
perfusion. This deep hypothermia without perfusion reportedly keeps kidneys
"alive" for up to 24-48 hours, hearts up to 4-6 hours, and livers up to 6-8 hours.
These time constraints have made most transplantation procedures emergency
operations. Particularly for heart and liver transplants, for which large teams
are required, this call for 24 hour coverage by special personnel, which is
costly and draws personnel away from other more salvageable patients. Continued
perfusion with cold plasma substitute of kidneys has extended the "alive" period
up to about 72 hours. There is a 25% loss of donor organs, partly due to non-
viability reached between removal and implantation. I do not understand why such
a primitive method of organ preservation prevails, and only minimal research
toward improving organ preservation has been initiated. Since the turn of this
century, physiologists have kept hearts beating outside the body for hours, using
perfusion techniques. If organs removed from heart beating cadavers could
immediately be "plugged into" an effective (not yet developed) preservation
system, which would keep them "alive" for up to 1 week, one could not only make
use of perhaps 20% more organs than is now the case from presently available
donors, but also reduce the cost and manpower drain away from other parts of
medical care by changing these emergency operations into planned elective
procedures, which can be carried out in a safer and less costly way during day
hours. Also the matching of donor to recipient could be done more thoroughly and
the transport of organs over greater distances would be feasible.
Therefore, I recommend facilitation of organ preservation research and its
funding by the National Institutes of Health. This is closely related to
resuscitation research, which includes preserving the whole body and returning
the whole organism from total circulatory arrest by reperfusion-reoxygenation,
to viability of vital organ systems. For the preservation of transplant organs
the questions to be pursued include: What are the limits of circulatory arrest
time tolerated by each organ system, with and without reperfusion? While
reduced temperature decreases metabolism and thereby protects against lack of
oxygen and nutrient supply, the optimal low temperature which gives greatest
reduction in metabolism and least tissue damage remains to be determined. What
are the low limits of temperature tolerated in terms of hypothermia-induced
tissue damage, using various perfusion fluids? What is the best perfusion fluid
(plasma substitute vs. oxygen carrier, vs. blood), perfusion pressure and pattern
(pulsatile vs. non-pulsatile flow), and temperature for preservation? What are
the best methods for rewarming and reoxygenation? Should rewarming be done
before implantation? What treatments should be part of reperfusion to sustain
optimal viability of organs? There are various drugs and microcirculation
promoting measures now being studied in our Center and others, for brain
protection before and brain resuscitation after circulatory arrest, which may be
suitable for organ preservation. While simple methods exist for efficient
delivery of oxygen and removal of carbon dioxide, what would be the most cost-
effective method for removal of metabolic by-products? These and other questions
would have to be pursued separately for each organ. Of course, organ preserva-
tion would be greatly facilitated if multiple organ transplantations were to be
carried out in only a few centers and multiple organ donors' heart beating
cadavers were transferred with artificial ventilation to these centers.
657
Cerebral death. At present only corneae of eyes, bones, vessels and other
organs with low metabolism are successfully transplanted after removal from non-
heart beating cadavers at autopsy. Kidney, heart, liver and lungs must be taken
from heart beating cadavers with brain death, and reach, via some preservation
method, the recipient. Brain death, which can be determined with 100% certainty
by a special combination of clinical and laboratory methods, equals "death" in
medical and legal definitions. Brain death implies no spontaneous breathing, as
it represents irreversible destruction of the entire brain, including the high
thinking areas and the lower mid-brain and brain stem areas for vegetative
existence. Brain death implies no spontaneous breathing.
Following injury or prolonged oxygen lack (as in heart arrest followed by
resuscitation), many patients develop "cerebral death", not death of the entire
brain. Cerebral death is irreversible destruction of the "cerebrum", with
continued viability and activity of the mid-brain, cerebellum and medulla. These
patients may breathe spontaneously, do not show some other signs of brain death
(such as absent cranial nerve reflexes), but also are unresponsive and have no
chance to recover human mentation. Cerebral death has also been named persistent
vegetative state, apallic syndrome, or social death. Biomedical ethics in my
opinion should not only equate brain death, but also cerebral death with "death,".
This would make a patient like Karen Quinlan, who is in such a persistent
vegetative state, a "breathing and heart beating cadaver". Neither medicine nor
society is ready to include patients with cerebral death among potential trans-
plantation organ donors. From a medical-scientific and ethical point of view,
however, the only missing link is the documentation, with 100% certainty, that
the vegetative state diagnosed is irreversible. Such proof exists when with
special methods one finds no blood flow through the cerebrum, when oxygen uptake
is greatly reduced (difficult to measure), or when CAT x-ray examination shows
severe atrophy of the cerebrum. Research in our and others' laboratories also is
presently searching for chemical measurements with which one might prove early
after an insult, the irreversible destruction of the higher centers of the brain
in the absence of brain death. Since cerebral death develops more slowly, one
would have to wait for up to about 1 month after head injury and at least 1-2
weeks after heart arrest, before one can clinically determine the irreversibility
of this state. Much research is needed, and should be funded by the National
Institutes of Health, on the documentation of the irreversibility of cerebral
death (without total brain death), and on methods which might be considered for
organ removal from heart beating and breathing cadavers. Therefore, the time for
including cerebral death victims among potential organ donors has not yet come.
658
RECOMMENDATIONS
1. Organ transplantations should receive priorities from national, regional
and institutional planning groups, as one among many vital health care needs
of the nation, and in consideration of available finite resources, quality
of survival and alternative therapies. Competing priorities include
programs to combat malnutrition, infectious diseases, neonatal mortality,
atherosclerosis, sudden cardiac death, and death and crippling from trauma.
2. As soon as a specific organ's transplantation procedure has emerged from the
stage of research and is considered part of general life saving medical care
(e.g., kidney transplantation), regional programs and legislations should
facilitate procurement of organs to be matched with needs.
3. Since presently many more donor organs (kidneys, hearts, livers) are needed
than are donated, procurement must be increased. Plans should now be made
for the time when the immune rejection problem will have been solved by
ongoing research, and the public will demand a massive increase in procure-
ment.
4. Possible mechanisms for increasing organ procurement now include the
motivating of physicians (particularly critical care medicine-intensive
care unit physicians, emergency physicians, neurosurgeons and neurologists)
to identify all potential organ donors and to initiate transfer, brain death
determination and certification, obtaining of consent, removal and preser-
vation of viable organs, and matching with the most appropriate recipients-
all in an orderly manner with the collaboration of organ procurement-
transplant agencies at the regional and national levels.
5. Orderly brain death certification and interhospital transfer of organs or
heart beating brain dead donors should be enhanceAby appropriate changes in
Medicare reimbursement and in hospital accreditation requirements by state
governments and the Joint Commission on Accreditation of Hospitals.
6. Another mechanism for increasing organ procurement would be legislation for
"presumed consent" for autopsies and organ removal for transplantation, as
it exists in several European countries. Although desirable, efforts toward
such presumed consent legislation might cause a backlash. Therefore, an
opinion poll should be conducted before promoting such legislation.
7. Research into improved and prolonged preservation of donor organs should be
fostered and funded by the National Institutes of Health. Improved organ
preservation is badly needed, not only for the better utilization and
retention of available organs, but also for making transplant operations
elective, and thereby safer and less expensive than present emergency
transplant operations. The not entirely Utopian goal would be organ banks
not only for corneae, bones, etc., but also for kidneys, hearts, lungs,
livers and other vital organs.
8. Research into "cerebral death" determination should be fostered and funded
by the National Institutes of Health. At present, the only sources of donor
kidneys, hearts, lungs and livers are heart beating cadavers with brain
death. In the future, additional sources could be heart beating and
breathing cadavers with cerebral death. In brain death, the entire brain is
destroyed (higher and lower centers). In cerebral death, the higher centers
only are destroyed, which results in permanent loss of human mentation and
unconsciousness (persistent vegetative state, neocortical death, apallic
syndrome, social death). Once cerebral death can be determined with 100%
reliability (as is now the case for brain death), it should also be equated
with "death." This would call for "letting die" for socio-economic and
ethical reasons, which in turn would permit organ donation. Much research,
however, is still needed before establishment of appropriate methods for
reliable determination of cerebral death and methods for subsequent organ
removal .
659
REFERENCES
Selected References with Pittsburgh Authors
1. Safar P: The intensive care unit. Anaesthesia 16:275, 1961.
2. Safar P, Grenvik A: Organization and physician education in critical care
medicine. Anesthesiology 47:82, 1977.
3. Safar P: Cardiopulmonary Cerebral Resuscitation. A Manual for Physicians
and Paramedical Instructors, Prepared for the World Federation of Societies
of Anaesthesiologists. Stavanger (Norway), A. Laerdal; Philadelphia,
W.B. Saunders, 1981.
4. Grenvik A, Safar P: Brain Failure and Resuscitation. New York, Churchill
Livingstone, 1981.
5. Wecht C (Chairman), Safar P, Grenvik A, et al : Determination of death. Ad
Hoc Committee on Human Tissue Transplantation Reports Criteria. Bulletin of
the Allegheny County Medical Society 25:29, 1969.
* 6. Grenvik A, Powner DJ, Snyder, et al : Cessation of therapy in terminal illness
and brain death. Crit Care Med 6:284, 1978.
*7. Grenvik A: Brain death and permanently lost consciousness. In, Principles
of Critical Care Medicine (Grenvik A, Shoemaker W, et al , editors).
Philadelphia, W.B. Saunders, in press, 1983. I
*8. Grenvik A, Hardesty R, Griffth B, et al : Multiple organ procurement by inter-
hospital transfer of heartbeating cadavers. In, Organ Procurement (Kootstra G,
editor). Proc. International Congress on Organ Procurement, Maastricht,
Holland, April 14-16, 1983.
9. Lynn J (coordinator, President's Commission on Biomedical Ethics): Guidelines
for the determination of death. JAMA 246:2184, 1981.
10. Safar P: Resuscitation Research Center, University of Pittsburgh. Resuscitation
7:69, 1979.
11. Safar P: Reanimatology -- the science of resuscitation. Crit Care Med 10:
134, 1982.
12. Safar P: Cerebral resuscitation: current state of the art. Ann Emerg Med
11:162. 1982.
13. HakalaT: Request reports on kidney transplantation, Univ. of Pittsburgh.
14. Bahnson H: Request reports on heart transplantation, Univ. of Pittsburgh.
15. Starzl T: Request reports on liver transplantation, Univ. of Pittsburgh.
* see enclosures
660
Selected Papers by Others on Organ Donation and Transplantation
16. Beecher H: Harvard Medical School Ad Hoc Committee to examine the definition
of brain death: A definition of irreversible coma. JAMA 205:337, 1968.
17. Bart KJ, Macon EJ, Whittier FC, et al : Cadaveric kidneys for transplantation.
A paradox of shortage in the face of plenty. Transplantation 31:379, 1981.
18. Sells RA: Live organs from dead people. J Royal Soc Med 72:109, 1979.
19. Bart KJ, Macon EJ, Humphries AC, et al: Increasing the supply of cadaveric
kidneys for transplantation. Transplantation 31:383, 1981.
20. Stuart FT, Veith FJ, Cranford RE: Brain death loss and patterns of consent
to remove organs for transplantation from cadavers inthe United States and
28 other countries. Transplantation 31:238-243, 1981.
21. Dukeminier J, Jr, Sanders D: Organ transplantation: a proposal for routine
salvaging of cadaver organs. N Engl J Med 279:413, 1968.
22. American Medical Association, Council on Scientific Affairs: Organ donor
recruitment. JAMA 246:2157, 1981.
661
0CW-3493/78/0604-028.1S02 00/0
Critic \l Carf. Mfdicine
Copyright 0 1978 by The Williams & Wilkins Co
Vol. 6. No 4
Primed in U.SA-
Cessation of therapy in terminal illness and
brain death
AKE GRENVIK, MD; DAVID J. POWNER, MD; JAMES V. SNYDER, MD;
MICHAEL S. JASTREMSKI, MD; RALPH A. BABCOCK, MD;
MICHAEL G. LOUGHHEAD, MD
Extracorporeal oxygenation may be considered in
relatively young patients with severe respiratory fail-
ure and inadequate pulmonary gas exchange despite
sophisticated mechanical ventilation. Similarly, when
a failing heart does not respond to conventional med-
ical and surgical treatment, it is appropriate to con-
sider augmented circulation by intraaortic balloon
pumping or left ventricular assist devices, or even
cardiac transplantation. However, for patients with
irreversible failure of multiple organ systems, terminal
neoplasia, or complete and irreversible brain failure,
medical, philosophical, moral, financial, and theolog-
ical considerations may dictate limitation or removal
of those diagnostic and therapeutic measures which
have been judged inappropriate. But until reliable
criteria for predicting irreversible severe brain damage
become available, physicians must continue to use
highly individualized judgment based on a combina-
tion of the medical team's clinical experiences, pub-
lished data, and outcome prediction indices, as well
as the patient's own wishes, stated while still conscious
and mentally competent. This has created a significant
dilemma for most physicians, best illustrated by the
famous Karen Ann Quintan case in New Jersey,
where the Supreme Court requested that the hospital
establish an "Ethics Committee" to make these deci-
sions regarding withdrawal of therapy, as has previ-
ously been done at Massachusetts General Hospital
in Boston.1
A TRIAGE PROGRAM FOR CRITICAL CARE
Since modern technological advances have given
today's physicians the ability to prolong life in criti-
From the Department of Anesihesiology/Criucal Care Medi-
cine. University of Pittsburgh, Pittsburgh. PA 15261.
Dr. Grenvik ,s Professor and Director of Critical Care Medicine
Progranv
Drs. Powner and Snyder are Assistant Professors.
Drs. Jasiremski and Babcock were Critical Care Medicine Fel-
lows.
Dr. Loughhead was Visiting Assistant Professor.
cally ill patients even when cure is no longer possible
and a final cardiac aiTest is inevitable, physician
control over the time and mode of dying has greatly
increased. Consequently, controversy has arisen over
unwarranted cardiopulmonary resuscitation (CPR)
and continued life support in certain situations.23 In
fact, if an agreement has been reached with the patient
or his relatives not to perform resuscitation, such
therapy would be a violation of that patient's right to
determine his own care.5 The terms "Do Not Resus-
citate", "DNR" or "No Code" have commonly been
applied to such patients. In our experience, however,
these terms are very confusing since they have been
interpreted to mean anything from complete with-
drawal of all therapy to aggressive support of the
patient with the exception of CPR.
To define more closely those aspects of care consid-
ered appropriate within each patient's total care plan,
Presbyterian University Hospital implemented
"Guidelines for the Care of Hopeless/Moribund Pa-
tients" in 1975. These guidelines separate the "Do
Not Resuscitate" patients into two categories: "All
But CPR" and "No Extraordinary Me 'sores". To-
gether with previously designed guidelines for th •
evaluation and certification of death based on "Brain
Death",* to be discussed below, the new guidelines
permit distinct categorization of all ICU patients into
four different groups: "Total Support", "All But
CPR", "No Extraordinary Measures", and "Brain
Death" (Table 1). It should be noted that the condi-
tion and prognosis of the patient's brain is of great
importance for selecting the appropriate category,
since the function of many of the other vital organs in
the body can be artificially supported.
Following ICU admission, all patients are catego-
rized as and receive "Total Support" until a thorough
data base has been obtained concerning diagnosis,
organ system involvement, likely prognosis, etc. Si-
multaneously, any potentially reversible aspects of the
patient's illness are aggressively treated. After consul-
284
662
Vol. 6, No. 4
Grenvik el al— TERMINAL ILLNESS AND BRAIN DEATH
285
Table I. CCM mage program. Presbyterian University Hospital.
Pittsburgh, PA
1. Total support: all patients are assumed to be in mis category
on ICU admission. Critically ill or injured patients in whom
survival without Dersistent severe brain failure is expected, remain
in this category. Vital organ systems, although usually affected, are
not irreversibly damaged. In these patients, everything possible is
done to reduce mortality and morbidity.
2. All but CPR: these are patients with continuing brain function
or at least hope for some meaningful brain recovery and who have
irreversible cardiopulmonary or other multiple vital organ failure,
or are in the terminal stages of other incurable diseases, e.g.,
advanced carcinomatosis. Every indicated therapeutic approach is
utilized in these patients but only to the point of cardiac arrest.
When this occurs, CPR is not provided and the patient is permitted
to die.
3. No extraordinary measures: these are patients where some
forms of treatment seem meaningless, prolonging death rather than
life; examples are patients with mLnmal brain function without
hope for improvement and thus no prospect for future human
mentation. In these cases, extraordinary measures, such as defined
below and within the patient record, are usually not initiated, and
are discontinued if such discontinuation is not expected to result in
immediate demise. Obviously, these patients will not be resuscitated
in case of cardiac arrest. In addition to CPR, extraordinary mea-
sures which may be withheld include: admission to the ICU;
arrhythmia control; tracheal intubation; life support with mechan-
ical ventilation and other assisting devices; use of artificial organs;
transplantation of organs and tissues, including blood and blood
by-products; invasive monitoring, parenteral nutrition; and iv in-
fusion of potent vasoactive drugs.
4. Brain death: patients with irreversible cessation of all brain
function are placed in this category. Once brain death has been
demonstrated by established criteria, the patient is declared dead
and all therapy is stopped. However, if organ donation for trans-
plantation is being considered, cardiopulmonary support is contin-
ued until the required organs have been removed.
tation with the Critical Care Medicine (CCM) physi-
cian and involved consultants, the attending physician
or his designate reviews the patient's classification at
least daily and may recategorize at any time. All such
decisions are discussed with the patient's family and
the wish of the mentally competent patient is also
always considered.
A progress note which identifies the reasons for the
categorization and includes information that a discus-
sion with the patient or the patient's family has taken
place and that all parties agree must be entered in the
medical record by the attending physician or his
designate. Likewise, an order is placed in the medical
record identifying the patient's category and defining
what therapy is considered appropriate or inappro-
priate in the patient's care, e.g., intubation and me-
chanical ventilation, treatment of dysrhythmias, etc.
This careful documentation of decision-making pro-
vides the necessary communication to other physician
consultants, nurses, and paramedical personnel as to
what treatment forms should or should not be antici-
pated. Thus, the initiation of therapy which has been
excluded from' the patient's care plan, e.g., CPR, or
the omission of an appropriate treatment is less likely
to occur. In the absence of an order identifying a
specific patient category, total support is always pro-
vided.
Our experiences with the new CCM Triage Pro-
gram were analyzed for the first two years following
its implementation. During July 1975 through June
1977, there were 1752 patients admitted to the ICU
(Table 2). Patients who remained in the "Total Sup-
port" category comprised 81.3% of the total admis-
sions and sustained an ICU mortality rate of 7.9%.
The "All But CPR" classification of 105 patients or
6.0% of all admissions had an ICU mortality rate of
80.0% as compared to 86.6% among the 142 patients
categorized as "No Extraordinary Measures", consti-
tuting 8.1% of the admissions. Eighty patients were
discharged within the "Brain Death" category, ac-
counting for 4.6% of the total ICU admissions. By
definition, brain dead patients had 100% mortality.
Of particular interest are those patients for whom
the designated treatment plan in their categories "All
But CPR" and "No Extraordinary Measures", re-
sulted in survival with transfer of the patients from
the ICU and the hospital (Table 3). Our results indi-
cate that the positive aspects of treatment must be
emphasized in these patients also. In both categories,
extensive treatment plans should be utilized, once the
proper role of each component has been defined
within the context of the probable prognosis of the
overall disease process. Therefore, the classification
guidelines best serve to stimulate and crystallize de-
cision-making as to what is the appropriate positive
extent of therapy, before excessive emotional, finan-
cial, and medical burdens are incurred by the patient,
family, and staff. As a communications system, these
guidelines serve to reassure family, staff and at times,
also the patient, that the inappropriate psychological
and/or physical discomfort or pain will be avoided.
Other systems have been described1" for patient
categorization and share as a goal the effort to lessen
unnecessary prolongation of death while providing an
appropriate level of support to patients with some
possibility of surviving and regaining at least basic
Table 2. CCM triage program, Presbyterian University Hospital,
Pittsburgh, PA. Distribution and ICU mortality within patient
categories 7/1/75-6/30/77
Category
Palienls
Deaths
Total support
All but CPR
No extraordinary mea-
sures
Brain death
Total
1425
105
142
80
1752
112
84
123
80
399
7.9
80.0
86.6
100 0
22.8
663
286
CRITICAL CARE MEDICINE
July-August, 1978
Table 3. CCM triage program, Presbyterian University Hospital.
Pittsburgh. PA. 7/1/75-6/30/77. Patients discharged alive from the
1CU categorized *'AH But CPR" or "No Extraordinary Measures"
No extraordinary
Category
All but CPR
(n= 105)
measures
(n = 142)
Died elsewhere in hospital
12(11.4%)
1 1 (7.8%)
Transferred to chronic care in-
5 (4.8%)
5 (3.5%)
stitution
Discharged home
4 (3.8%)
3(2.1%)
Total no. of patients discharged
21 (20.0%)
19(13.4%)
alive from ICU
levels of vital organ function, which includes brain
function.
BRAIN DEATH DETERMINATION
In those circumstances where no chance of mean-
ingful recovery of sapient function is possible because
all the brain itself has been functionally destroyed, a
process for certification of that state becomes neces-
sary.7 Traditionally, within both the medical and legal
professions, death of the patient has been equated
with irreversible cessation of respiratory and cardio-
vascular function. During the 1970's legislative at-
tempts have been made to define a second type of
death, i.e., brain death, based upon irreversible ces-
sation of all brain function. Regardless of the sequence
of events leading to this outcome, there is, however,
only one meaningful death event, i.e., death of the
brain. Thus, irreversible cardiac arrest, which can be
treated by insertion of an artificial heart or cardiac
transplantation, leads to death of the individual only
when brain function ceases.
As clinically defined, brain death identifies a per-
manent loss of all integrated neuronal brain func-
tion.8,9 The term "integrated" is important to the
definition, since recovery of some metabolic and elec-
trical activity in the brain following even 60 min of
total ischemia has been demonstrated experimen-
tally.10 It is also important to realize that there is a
difference between cerebral death and brain death,
the former permitting survival of parts or all of the
brain stem, pons, midbrain, and cerebellum, while the
latter indicates death of all brain structures above the
foramen magnum. So far, only brain death has been
medically and legally equated with death of the indi-
vidual.
Cardiac arrest usually occurs within 72 hours""1'4 in
the majority of brain dead patients supported by
mechanical ventilation. However, to our best knowl-
edge, the longest surviving body of a brain-dead
patient was a young male treated for 36 days in an
ICU; medical documentation of brain death was per-
formed repeatedly, including clinical evaluation plus
carotid and vertebral arteriography showing no evi-
dence of any blood supply to the brain (Holmdahl,
personal communication). Obviously, such intensive
therapy, if generally applied, would effectively
drain our medical and economical resources. Once
there is medical/scientific proof that all brain function
has irreversibly ceased, ethical and religious view-
points,'5, 16 both by professional authorities and the
lay public, justify death certification and cessation of
all treatment, now also accepted by the legal com-
munity as the only logical approach.1'"20
Specific criteria for determining brain death have
originated from many different groups including:
Harvard Medical School,7 University of Pittsburgh,21
University of Minnesota,22 University of Pennsylva-
nia,23 United States Navy,24 Medical Colleges of the
United Kingdom,25'26 National Institutes of Health
Collaborative Study on Cerebral Survival,9 and oth-
ers.27"30 While the many guidelines differ regarding
individual tests recommended, all require a detailed
careful neurologic examination and most include
EEG. Repeat evaluations may or may not be de-
manded. Reexamination after specified time intervals
has been recommended. These intervals include: 24
hours,7 6 to 12 hours,14' 23'24'31 2 to 3 hours,4' 21- 32 30
min,22 or variable time periods depending upon etiol-
ogy.25 Certification of brain death after a single ex-
amination in patients with known and irreversible
cause for complete brain dysfunction has also been
supported.9' 12'25'27'30
The so-called persistent vegetative states,33'34 with
severe neurological dysfunction yet some persisting
brain activity, are a separate ethical and medical issue.
These conditions must be actively sought and ex-
cluded from the brain-dead patient population. They
can generally be subdivided into: (1) "locked-in" syn-
dromes (akinetic mutism, paralytic akinesia, cerebro-
medullospinal disconnection), wherein some mental
awareness may be preserved and significant cranial
nerve dysfunction exists but voluntary muscle move-
ments are absent,35"37 e.g., medullo-pontine lesions;
(2) clinical states characterized by profoundly de-
pressed levels of awareness with associated EEG de-
pression even to an isoelectric level but with brain
stem function which continues or can be evoked,38"48
sometimes is also referred to as the apallic syndrome.49
It is obvious from the above that both cortical and
brain stem functions must be cautiously examined by
any criteria adopted for determination of brain death.
A well defined set of criteria was developed in Pitts-
burgh in 1969 by a committee of clinicians, lawyers,
philosophers and clergymen21 and was implemented
the same year4 in the ICU at Presbyterian University
Hospital. These criteria have been modified in 1978
to its present form (Fig. I). During 1970 through 1976,
176 consecutive cases developing brain death were
certified dead based on the original criteria (Table 4).
These did not include the need for hospital observa-
tion prior to brain death certification, the atropine
664
Vol. 6, No. 4 Grenvik el al — terminal illness and brain death 287
PRESBYTERIAN-UNIVERSITY HOSPITAL
Pittsburgh, Pa.
CRITERIA FOR THE DIAGNOSIS OF BRAIN DEATH
Note: The patient must be observed in the hospital
during treatment of potentially correctable
abnormalities (e.g. hypovolemic shock). Two
clinical examinations must then be performed;
the second no sooner than two hours after Date of Exam:
the first. Time of Exam:
A. Coma of established cause and absence of induced hypothermia and
central nervous system depressant drugs. A blood ethanol
level and/or other appropriate toxicology studies should be
performed if indicated. Body temperature should be recorded:
1 . Body temperature
2. Blood ethanol: __^^_
3. Toxicology studies: .
B. No spontaneous muscular movements and no evidence of decerebrate or
decorticate posturing or shivering (in the absence of muscle relaxants):
C. Cranial Nerve Reflexes and Responses:
1. Pupils light-fixed: —
2. Absent corneal reflexes: —
3. Unresponsiveness to intensely painful stimuli, e.g. supraorbital
pressure: —
4. Absent response to upper and lower airway stimulation, (e.g.
pharyngeal and endotracheal suctioning) :
5. Absent ocular response to head turning (no eye movement):
6. Absent ocular response to irrigation of the ears with 50 mis. of
ice water (no eye movement) : —
D. Absence of spontaneous breathing movements for 3 minutes and PaC02 above 50
torr at end of test (in absence of muscle relaxants). If a history suggestive
of dependence on a hypoxic stimulus for ventilation (e.g. a COPD patient) is
present, the Pa02 at end of test must be less than 50 torr.
1. PaCO^ at end of apnea test:
2. Pa02 at end of apnea test:
E. An isoelectric electroencephalogram recorded in part at full gain.
F. Failure to increase heart rate by more than five per minute following
1 mg. atropine sulfate intravenously:
1. Heart rate before atropine
2. Heart rate after atropine:
G. Comments:
CERTIFICATION
Having considered the above findings, we hereby certify the death of:
Date: Time:
Physicians Signature M.D. . H.V.
Names Printed: M.D. . M-D-
This document should be signed by two physicians licensed by the State of Pennsylvania.
REVISED: January, 1978
Fig I.
665
288
CRITICAL CARE MEDICINE
July-August, 1978
Tabll 4. Patients certified brain dead 1970-1976 Presbyterian
University Hospital. Pittsburgh, PA
No. (%)
Age
Etiology
Range
Mean
Cerebral bleeding
70 (39.8)
18-76
44
Trauma
58 (32.9)
11-65
30
Postresuscitalion
20(11.4)
17-89
48
Vascular occlusion
14 (8.0)
18-76
44
Tumor
6(3.4)
22-62
48
Miscellaneous
8 (4.5)
16-54
43
Total
176(100.0)
11-89
41
test, and the hypoxemia test in COPD patients but
were otherwise identical to those shown in Figure 1.
The etiologies responsible for brain death and other
characteristics of this patient group are summarized
in Table 4. In all patients, therapy with total life
support techniques was continued during diagnostic
evaluations directed toward identification of a revers-
ible etiology of the depressed brain function. If toxic,
metabolic, pharmacological, infectious, or any other
potentially reversible cause of coma could be defined,
appropriate therapy was continued and the brain
death certification process suspended. Different forms
of shock, if present, will aggravate any coexisting
cerebral dysfunction, e.g., in multiple injury'1 and
must, therefore, be vigorously treated before brain
death evaluation takes place.9
Our criteria for brain death include complete ab-
sence of cerebral and brain stem activity on two
clinical examinations, performed at least 2 hours apart
and a single isoelectric EEG which is recorded using
standardized technical guidelines to ensure maximal
sensitivity,50 i.e., recording with and without auditory
stimulation for at least 30 min, part of which must be
with an amplification of two microvolts per mm. The
EEG is usually obtained during the interval between
the first and second clinical examinations. Neuromus-
cular blockade with succinylcholine, pancuronium, or
curare may be used to abolish muscle artifacts which
interfere with the EEG tracing, but the effects of these
agents must be absent before the subsequent clinical
examination. This can easily be tested with an electric
nerve stimulator, routinely used in anesthesiology for
monitoring of the effects of such muscle relaxants.
A standardized neurological examination of cranial
nerve activity and a three minute apnea test to detect
signs of spontaneous breathing activity comprise the
clinical phase of the evaluation. It is mandatory that
brain stem, and not spinal cord activity, be investi-
gated in the diagnosis of brain death, as spinal cord
neurons may remain viable after brain function has
ceased. Somatic motor movements from persistent
spinal reflex activity were seen in 10.8% of our pa-
tients,4 in agreement with the 9% incidence reported
by others.12 Occasionally, complex movement patterns
may be seen, caused by spinal cord reflexes.4. In
these cases, simultaneous recording of the EEG during
such movements provides assistance in excluding their
origin in the brain.
Several hazards may be associated with the test for
apnea. Because hypocarbia may induce apnea,51 the
Paco2 should be normal at the start of the test.
However, we have observed dramatic increases in
intracranial pressure when the Paco? was allowed to
rise to normal levels for an apnea test. This demon-
strates the potential for further compromise of brain
function during this test. Likewise, the patient should
not become hypoxemic during the test. Therefore, it
is required that before initiation of the apnea test, all
other criteria of brain death be met, no effect of
neuromuscular blocking agents be present, the patient
be well oxygenated and the Paco2 normalized.52 After
arterial blood gas analysis confirms this, the patient is
disconnected from the ventilator and closely observed
for 3 min. If no respiratory efforts are detected after
3 min, a second set of arterial blood gases is obtained
and the patient reconnected to the ventilator. The
apnea test is considered valid only if Paco2 is well
above normal range after 3 min of apnea. This indi-
cates absence of ventilatory response to hypercarbia.
If the patient's history suggests a dependence upon
hypoxic drive for ventilation, the apnea test is con-
ducted at that level of oxygenation.
When a patient fulfills the above criteria for brain
death, he is certified dead by two licensed physicians.
Because certification of death is the legal duty of the
attending physician and although the relatives are
always carefully informed about the various ramifi-
cations of brain death, the family's permission is not
a required part of this procedure. The time of death
is the time of brain death certification and not the
time of cessation of cardiac activity. After the family
has been informed of the death, mechanical ventila-
tion is discontinued and the body kept in the ICU
until cardiac activity ceases. If organ removal for
transplantation purposes is to be performed, such
brain-dead organ donors receive continued cardio-
pulmonary support until the donated organs are re-
moved in the operating room. As soon as this has
been completed, all cardiopulmonary support is dis-
continued and the body kept in the operating room
until cardiac activity stops.
Management of brain-dead organ donors may at
times be difficult. Cardiovascular instability, defined
as a systolic arterial pressure of less than 100 mm Hg
for more than 1 hour or the presence of a potentially
fatal arrhythmia, occurred in 45% of our patients/ It
is important that these possibilities be excluded as a
potentiating cause of brain dysfunction via hypoper-
fusion prior to certification of brain death. Also,
fluids, inotropic drugs, and other support of the car-
diovascular system in the brain-dead patient may be
necessary to preserve donor organ viability.
666
Vol. 6, No. 4
Crenvik et at— TERMINAL ILLNESS AND BRAIN DEATH
289
A wide variety of arrhythmias was encountered in
our patient group. Although most responded to con-
ventional therapy, it is important to realize that
bradyarrhythmias will not respond to atropine, be-
cause their etiology is not that of increased vagal
activity. In fact, an increased heart rate after atropine
in a presumed brain-dead patient negates the diag-
nosis, as the atropine test is a sensitive indicator of
brain stem function.2.
Diabetes insipidus as a manifestation of absent
hypothalamic function occurred in 8.5% of our pa-
tients4 and necessitated careful fluid and electrolyte
management.
DISCUSSION
The described method of CCM triage appears to be
a useful system for any hospital. It is likely to be
strengthened in the future when and if objective and
reliable prognostic indicators of severe irreversible
brain damage become available, in addition to those
already proposed for other serious conditions.53"56
The participation of family members within our
triage program is an absolute necessity for continuity
of the patient-family-physician relationship through
communication and education. Hesitation on the fam-
ily's part is met with additional sensitive discussions
and, when indicated, continued education concerning
the patient's condition and the implications of changes
in his or her status.
We have also seen cases in which relatives have
requested withdrawal of treatment when the involved
physicians considered the patient to have a sufficient
chance of survival to warrant continued life support.
In one drastic example, both the referring physicians
and the relatives were led to believe that the patient
had already succumbed due to irreversible cessation
of all brain function. This was an 18-year-old man,
admitted to our ICU with multiple injuries including
brain contusion following a severe automobile acci-
dent. He was referred from another hospital for the
sole purpose of kidney donation with consent forms
for removal of these organs already signed by the
parents. However, since the patient was in hypovo-
lemic shock and did not meet our brain death criteria,
total support was provided. He responded well to
vigorous treatment of his hypovolemia and was dis-
charged from the hospital after 2 months with his only
residual neurological deficit being a right hemiparesis
and slight impairment of higher cognitive functions.'1
Thus, the flexibility of this categorization system
serves to reinforce the privileges of the medical profes-
sion in exercising their therapeutic prerogatives.
Patient categorization may be influenced but should
not be automatically dictated by non-medical factors,
such as those patients who may have declared an
intention to "die with dignity" by means of a prepared
statement, in writing or orally at some point before or
during their hospitalization; in situations involving-
patients whose organs may be obtained at their death
for transplantation into other patients; and those pa-
tients who may have declared an intention to donate
their whole body or parts of it to science.
To emphasize the patient's right to refuse treatment,
a legalized "living will" has been established in several
states of the nation. This means that a physician
following the instructions given by the patient cannot
be legally accused of negligence when withdrawing or
withholding treatment, if the patient's instructions to
do so are clearly indicated in his living will. However,
the cause of the patient's condition must be that which
he had in mind when signing his living will, such as
widespread cancer, and not a different medical prob-
lem which might be relatively easily correctable.
Traditionally, physicians in communication with
the patient or the next of kin have decided on indi-
cated therapeutic approaches. Our system does not
deviate from this concept, only organizes this physi-
cian-patient-family relationship and decision-making,
to avoid confusion and to emphasize that therapy
deemed appropriate is, indeed, provided.
In this context, we are concerned with the recent
decision of the Supreme Judicial Court in Massachu-
setts in the Saikowicz case,57"59 indicating that deci-
sions regarding withdrawal of treatment in any men-
tally incompetent or comatose patient must be done
by court order and not by the attending physician.
This not only reflects distrust of the medical profes-
sion but also introduces a cumbersome, unmanage-
able, expensive mechanism of triage in patient care.
The cost versus the quality of survival for ICU
patients is an often discussed tangential issue.60 We
feel that continuing therapy, utilizing all forms of
modern biomedical technology in patients who in the
best considered medical opinion have no chance of
survival with human mentation, is medically, ethically
and economically unsound. Our system to identify
patients in whom maximal expenditure of medical,
emotional and manpower resources is inappropriate,
has the potential for considerable financial saving to
the society at large, estimated at 1 to 2 billion dollars
per year in the United States alone. These resources
may then be redirected toward patients whose prog-
noses are more favorable. Hence, this effort of patient
categorization is not only to reduce the amount of
inappropriate care, but also to increase the availability
of care to those for whom that care is appropriate.
CONCLUSIONS
The following advantages of a triage program for
critical care medicine have been identified:
1. It is a practical plan for management of all ICU
patients.
2. It allows maximal efforts towards viable patients.
3. It provides a more humane ICU environment for
667
290
CRITICAL CARE MEDICINE
July-August, 1978
all involved (patients, relatives, physicians, nurses,
and other ICU personnel).
4. It offers improved morale among ICU personnel.
5. It reduces overall expenses.
The disadvantages may include occasional misin-
terpretations of criteria. This necessitates careful su-
pervision of the system at all times by individuals
familiar with the program.
SUMMARY
Modern technological advances have given today's
physicians the ability to prolong life in critically ill
patients even when cure is no longer possible. Con-
sequently, controversy has arisen over unwarranted
continued life support in these situations. Fear of
lawsuits in recent years has added to the confusion.
Therefore, guidelines were developed at Presbyterian
University Hospital in Pittsburgh which make it pos-
sible to categorize each ICU patient into one of the
four categories: 'Total Support", "All But Cardiopul-
monary Resuscitation", "No Extraordinary Mea-
sures", and "Brain Death". Implementation of this
categorization has proven to be a practical plan for
management of all ICU patients. It allows maximal
efforts towards viable patients, provides a more hu-
mane ICU environment for all involved, offers im-
proved morale among ICU personnel and reduces
expenses. However, the system necessitates careful
supervision by a physician familiar with it.
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diffusion oxygenation, and organ transplantation. J Trauma
18:180-183. 1978
53. Afifi AA. Sacks ST. Liu VY, et al: Accumulative prognostic
index for patients with barbiturate, glulelhimide and mepro-
bamate intoxication. N Engl J Med 285: 1497-1502, 1971
54. Afifi AA, Chang PC, Liu VY, et al: Prognostic indexes in acute
myocardial infarction complicated by shock. Am J Cardiol
33:826-832, 1974
55. Shoemaker WC, Elwyn DH. Levin H. et al: Early prediction of
death and survival in postoperative patients with circulatory
shock by nonparametric analysis of cardiorespiratory variables.
Cm Care Med 2:3 17-325, 1974
56. Civetta JM: The ICU millieu: An evaluation of the allocation
of a limited resource. Respir Care 21:498-506. 1976
57. Curran WJ: The Saikewicz decision. N Engl J Med
298:499-500. 1978
58. Relman AS: The Saikewicz decision: judges as physicians. N
Engl J Med 298:508-509, 1978
59. Barnes BA. Carpenter CB. Dunlop GR. el al: Massachusetts
Supreme Court decisions affecting medical practice. N Engl J
Med 298:516-517. 1978
60. Cullen DJ, Ferrara LC, Bnggs BA, et al: Survival, hospitali-
zation charges and follow-up results in critically ill patients. A'
Engl J Med 294:982-987, 1976
ERRATA
The following change should be made in the article entitled "A method of
maintaining sterility of heated humidifiers in mechanical ventilator breathing cir-
cuits" by Robert S. Deane, MB, Bch, et al., published in the January-February 1978
issue of CRITICAL CARE MEDICINE. On page 61, line 9, following J. H. Emerson
Co., Cambridge, MA) the following should be inserted "A-G. A 9 inch long, % inch
diameter copper pipe". . . .
The following change should be made in the article entitled "Pentobarbital therapy
for intracranial hypertension in metabolic coma. Reye's syndrome" by Lawrence F.
Marshall, MD, et al., published in the January-February 1978 issue of CRITICAL
CARE MEDICINE. On page 3, line 11 the dosage of mannitol should be: (0.125 gl/
kg dose).
As a result of the number of printer's errors in the article entitled "Cardiorespira-
tory and metabolic effects of profound hypothermia" by Omar Prakash, MD, et al.,
published in the May-June issue of CRITICAL CARE MEDICINE it will be
reprinted in its entirety in the September-October issue.
The editor regrets any confusion caused to the readers as a result of these errors.
669
HOLLAND VERSION 4-12-83
In, Organ Procurement (Kootstra G, editor).
Proc. International Congress on Organ Procurement,
Maastricht, Holland, April 14-16, 1983.
MULTIPLE ORGAN PROCUREMENT BY INTERHOSPITAL TRANSFER
OF HEARTBEATTNG CADAVERS
A Grenvik MD, R Hardesty MD, B Griffith MD, B Shaw MD, T Rosenthal MD
T Hakala MD, J Reilly MD, D Denny, J Snyder MD, T Starzl MD, H Bahnson MD
Departments of Anesthesiology and Surgery and the
Critical Care Medicine Program
University Health Center of Pittsburgh
Pittsburgh, Pennsylvania, U.S.A.
t T_mn
670
When brain death develops in serious illness or severe head injury,
cardiac arrest usually occurs within 72 hours in patients supported by
■I
mechanical ventilation (1-4) . It is during this brief period of time that
organ donation can be considered. The concept of brain death has changed
little since the publication of the original Harvard criteria in 1968.
However, legislation in this field has been slow and to date eleven states
still lack legal identification of death which includes brain death.
Therefore, the American Guidelines for the Determination of Death,
published by the President's Commission for the Study of Ethical Problems
in Medicine and Biomedical and Behavioral Research (5) , were particularly
welcome by transplantation centers, since up to date standards were
established which clarified certain problems in the Harvard criteria (6) .
These guidelines by the President's Commission require documentation that:
1) cerebral and brainstem functions are absent; 2) this condition is
irreversible which necessitates known cause of the condition and exclusion
of the possibility of recovery; and 3) the cessation of all brain functions
persists for an appropriate period of observation and/or trial of therapy.
To avoid confusion between brain death and the so-called persistent
vegetative states (7), the President's Commission Guidelines (5) also
advise that the criteria physicians use in determining that death has
occurred should: 1) eliminate errors in classifying a living individual as
dead; 2) allow as few errors as possible in classifying a dead body as
alive; 3) allow a determination to be made without unreasonable delay; 4)
be adaptable to a variety of clinical situations; and 5) be explicit and
accessible to verification.
The criteria for brain death used at Presbyterian-University Hospital
(PUH) in Pittsburgh (see Appendix) include conplete absence of cerebral and
brainstem activity on two clinical examinations, performed at least two
671
hours apart, plus a single, maximally sensitive, isoelectric EEG (8) . This
EBG must be recorded with and without auditory stimulation for a minimum of
30 minutes and at least part of the test must use an amplification factor
of two microvolts per millimeter. The clinical part of the evaluation is a
standardized neurological examination of cranial nerve activity and an
appropriate apnea test to detect signs of spontaneous breathing. If there
is any sign of brain function during either clinical examination, death
cannot be certified.
The most recent problem encountered in brain death certification is
the transport delay caused by conflicting criteria among hospitals
transferring dead patients for multiple organ harvest and transplantation
(9) . For transplantation of hearts, kidneys or livers, donor organs may be
retrieved at a distance from the transplant center. Kidneys are kept
viable in hypothermia with specially designed perfusion machines. Hearts
and livers are chilled by perfusion of hyperosmolar solutions at +4 C and
transported cold, sometimes thousands of miles by charter or private jet
air craft. While ischemia time is variably prolonged, risks to donor
organs are generally acceptable. However, in combined transplantation of
heart and lungs, the lungs are more prone to ischemic injury. For such
transplantation, ischemia time is minimized by procuring these organs at
the transplant center.
When a brain dead donor with a beating heart is transferred from
another hospital to PUH for the purpose of harvesting multiple organs, the
body arrives with full cardiopulmonary support including mechanical
ventilation, continuous infusion of IV fluids and electrolytes, FKG and
pressure monitoring, etc., for optimal preservation of extracranial organs.
The donor has already been certified dead at the referring hospital based
672
on brain death criteria. Consent has already been obtained from the
next-of-kin and coroner as indicated for organ removal.
The body is not admitted to a specific PUH physician but .the cardiac
transplantation group is responsible for management of the body and the
medical record. The surgical ICU physicians share this responsibility and
the orga'-' tcocurement group is also involved. The cardiac surgeons, SICU
staff physician and staff anesthesiologist on call jointly decide whether
it is feasible at the time to bring the brain dead donor to PUH. This
decision must be made prior to the body's departure from the referring
hospital .
The organ procurement group must notify all involved as soon as
possible, and in advance, of the decision to bring a brain dead body to
PUH. Those to be notified are: 1) emergency department; 2) admission
office; 3) ICU staff physician on call; <1) ICU charge nurse; 5) operating
room; and 6) staff anesthesiologist on call.
At the referring hospital, the organ procurement officer, dispatched
from UHCP, reviews the medical record of the organ donor, the criteria used
for determination of brain death and the result of this evaluation. This
individual reports by phone to the PUH SICU staff physician the condition
of these documents so that the SICU physician may determine, in advance,
the acceptability of the donor body at PUH.
The following steps are finally taken at PUH:
1) Emergency Department (ED) : The body is accepted at PUH and an
identification number is assigned. The estate of the deceased must not be
billed for any expenses incurred at PUH.
2) Intensive Care Unit: From the VD, the body is transferred to the
SICU for continued cardiopulmonary support and monitorinq. An SICU staff
physician with experience of brain death evaluation and certification
673
reviews the following documents which accompany the patient: 1) copy of
medical record from referring hospital; 2) copy of criteria used for brain
death certification (unless reviewed and approved by PUH in advance) ; 3)
copy of death certificate; 4) copy of consent for organ removal. The
organ procurement group is responsible for obtaining and bringing these
four documents with the body to PUH. The SICU staff physician writes a
progress note in the medical record of the donor at PUH, indicating that
all documents are in order and in agreement with current medical practice
regarding certification of death based on irreversible cessation of all
brain function.
3) Operating Room: The attending anesthesiologist provides cardio-
pulmonary support and fluid administration as indicated for continued
optimal condition of the extracranial organs. When the surgical procedure
for removal of all organs scheduled for harvesting has been completed, the
body is sent to the morgue.
4) Morgue: The usual procedure is followed for notification of those
responsible for proper disposition of the body.
The procedure described above permits removal of the heart and lungs
during optimal conditions utilizing cardiopulmonary bypass. When these
organs have been harvested, hypothermic perfusion is continued during
removal of the liver, kidneys and any other desired organ. Thus, the
technique described permits optimal procurement of multiple organs for
transplantation. However, we find strict adherence to carefully written
and previously approved policies and procedures to be of greatest
importance for this activity, especiallv since the medico-legal
responsibilities of the receiving hospital arc presently unclear, should
brain death certification of the transferred donor for any reason tie
erroneous as has happened in the past (10).
674
The heart transplantation program at the University Health Center of
Pittsburgh was initiated in June 1980. Since then 40 patients have been
transplanted with 26 survivors and a calculated actuarial three year
survival time of 50%. Liver transplantations were canmenced in February of
1981 and to date 107 patients have undergone 138 transplantations with 81
survivors (78%) . Kidney transplantations have been performed since the
late 1960's. After inclusion of cyclosporin A in the immunosupression
therapy in 1981, 201 patients have received 204 transplants with 154 were
primary and 50 retransplantations. In this material, there have been 12
deaths, i.e. 95% patient survival (graft survival 83%). In 1983, two
pancreas transplants have been performed with survival of both patients.
Combined heart and lung transplantations started in 1982 and so far 4
patients have been transplanted with 2 survivors.
It is particularly for transplantation of heart and lungs as one
combined organ system that the donors have been transferred to our medical
center for the purpose of multiple organ procurement. This was not done in
our first case of heart and lung transplantation. The donor organs were
procured at 180 miles distance from Pittsburgh after infusion of cold
electrolyte solution and then transported by air to our hospital.
Transplantation took place after 150 minutes of cold ischemia time. The
lungs failed completely with severe pulmonary edema leading to the
patient's death after three days in spite of heroic efforts including
extracorporeal membrane oxygenation. In the subsequent three cases, the
donor was transferred to PUH with greatly improved organ preservation. In
these three cases, the hearts and lungs functioned well from the onset.
Postoperative weaning from mechanical ventilation was uncomplicated
although one of these three patients later died from sepsis. The other two
675
remain survivors in excellent condition after three and six months at the
time of this presentation.
Because of the large number of transplantations performed at the
University Health Center of Pittsburgh and 15 years of experience with
evaluation and certification of brain death a well functioning policy for
certification of death based on irreversible cessation of all ■ brain
function has been established (11, 12). This policy was recently modified
to include the special circumstances related to transfer to PUH of brain
dead organ donors. Further, separate guidelines have been approved by the
hospital executive contnittee for management of such referred brain dead
organ donors.
676
REFERENCES
1. Korein J: The problem of brain death: Development and history.
Annals of the New York Academy of Science, 315:19-38, 1978.
2. Jorgensen EO: Spinal man after brain death. Acta Neurochir
28:259-273 1973.
3. Ibe K: Clinical and pathophysiological aspects of the intravital
brain death. Electroencephalogr Clin Neurophysiol 30:272, 1971.
4. Kimura J, Gerber HW, McCormick WF: The isoelectric electro-
encephalogram . Arch Intern Med, 121:511, 1968.
5. Guidelines for the Determination of Death. Report of the Medical
Consultants on the Diagnosis of Death to the President's Ccmmission
for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research. JAMA 246:2184-2194, 1981.
6. A definition of irreversible coma. Report of the ad hoc committee of
the Harvard Medical School to examine the definition of brain death.
JAMA 205:337, 1968.
7. Jennett B and Plum F: "The persistent vegetative state: A syndrome
in search of a name". Lancet 734, 1972.
8. Cerebral death and the electroencephalogram. Report of the Ad Hoc
Committee of the American Electroencephalogr aphic Society on EEG
criteria for determination of cerebral death. JAMA 209:1505-1510,
1969.
9. Chatterjee SN, Payne JE, Berne TV: Difficulties in obtaining kidneys
from potential postrtorten donors. JAMA 232:822-824, 1975.
10 . Jastremski MS, Powner DJ, Snyder JV, et al: Problems in brain death
determination. J Forensic Sci. 11:201-212, 1978.
11. Grenvik A, Powner DJ, Snyder JV et al: Cessation of therapy in
terminal illness and brain death. CCM 6:284-291, 1978.
12. Grenvik A: Legal aspects of brain death certification and withdrawal
of life support. Chapter in Principles in Critical Care Medicine, WB
Saunders, Philadelphia. Shoemaker W, Thompson L and Holbrook P (Eds),
1983.
677
L
Presbytcntm-Uiiwcisity Hospital of Pillslmr^li
Oi-Sii'n ■» OH.i-i Slnvlt Pimhurgh. (Vniny/iwim 15^1-'
CHECK LIST FOR DIAGNOSIS OF BRAIN DEATH
The patient must be observed in Ihe hospital during treatment of
potentially correctable abnormalities (e g hypovolemic shock) Two
clinical examinaiions must then be performed, the second no sooner
than two hours alter the first
E.
F.
CLINICAL EVALUATIONS
ffl r?
Dale of Exam:
Time of E«am:
Coma of established cause and absence„o( hypothermia (below 34'Q and
central nervous system depressant drugs A blood ethanol level and/or other
appropriate toxicology stud.es should be performed it indicated
Body temperature should be recorded
1. Body temperature;
2. Blood ethanol:
3. Toxicology studies:
No spontaneous muscular movements and no evidence of decerebrate or decorticate
posturing or shivering (in the absence of muscle relaxants):
Cranial Nerve Reflexes and Responses:
1. Pupils light -fixed:
2. Absent corneal reflexes:
3. Unresponsiveness to intensely painful stimuli, e.g. supraorbital pressure:
4. Absent response to upper and lower airway stimulation.
e.g. pharyngeal and endotracheal suctioning:
5 Absent ocular response to head turning (no eye movement)
6. Absent ocular response to irrigation of the ears with 50 mis of ice water
(no eye movement):
Absence of spontaneous breathing movements for 3 minutes and PaCO; above
60 torr at end of test (in absence of muscle relaxants) if a history suggesiive
of dependence on a hypoxic stimulus for ventilation (e g a COPD pat.ent) is present,
the PaO? at end of test must be less than 50 torr
1. PaCO; at end of apnea test
2 PaO; at end of apnea test
An isoelectric electroencephalogram recorded in part at full gam
Failure to increase heart rate by more than five per minute following
atropine sulfate intravenously in a dose ol 0.04 mg/kg;
I. Heart rate be tore atropine:
2 Heart rale aller atropine:
Comments .
CERTIFICATION OF DEATH
Having considered (he above findings, we hereby certify the death of
Date
Physicians' Signatures
Time
. MO
Names Printed
MO
MO
This document should be Signod by two physicians licensed by the Slate ot Pennsylvania
'
678
PRESBYTERIAN-UNIVERSITY HOSPITAL
POLICY MANUAL
PAGE: 5108
INDEX TITLE: Patient Care
SUBJECT: Certification of Death Based on
Irreversible Cessation of All Brain
Function Including that of the Brain Stem
DATE: February, 1983
POLICY
It is the policy of Presbyterian-University Hospital while assuring op-
timal medical care to all patients to recognize that under certain cir-
cumstances, all medical therapy and life support shall be with-
drawn after certification of patient death, including those patients
in whom total and irreversible cessation of brain function can be
clearly demonstrated according to the criteria listed below.
CRITERIA
The patient must be observed for an appropriate period of time in the
hospital ICU during treatment of potentially correctable abnormalities
which may contribute to deteriorated brain function, e.g. hypovolemia,
hypoxemia, hypotension, hypothermia and presence of CNS depressant
drugs including alcohol.
The cause of coma must be established and be sufficient to explain
irreversible cessation of all brain function.
A check list of criteria is attached for the diagnosis of brain death
(originally approved by the Executive Commmittee of Presbyterian-University
Hospital in April, 1969, PUH: form number 900) and must be utilized in the
brain death evaluation and certification process.
In those cases where a donor is transferred to PUH following Cert-
ification of Brain Death at another hospital, the Death Certificate
must accompany the body and this must be documented by a PUH staff
physician.
Only when organs are donated for transplantation purposes will card-
iopulmonary and other essential organ support continue after death
until donated organs have been removed.
PROCEDURE
A. When drugs may be implicated by the history of physical examination
as a possible etiology of depressed brain function or in patients
with coma of unknown etiology, toxicological screening and/or anal-
ysis for specific drugs are indicated. If, in addition, alcohol
has been ingested, the synergistic effect between alcohol and such
drugs must be considered and blood alcohol levels obtained. Recent
679
general anesthesia, metabolic encephalopathies, encephalomeningi tides ,
hypothermia and shock may also influence the brain injured patient's
response during evaluation for potential brain death. Drugs known
to be associated with an isoelectric EEG include barbiturates,
methaqualone, diazepam, mecloqualone, meprobamate and trichlo'r-
ethylene (JAMA 236:1123, 1976). Blood levels of all such agents
must be absent or below therapeutic levels before brain death can be
certified. Similarly, if neuromuscular blocking agents have been used,
absence of the effects of these muscle relaxants must be secured by use
of a nerve stimulator, before the examination can proceed.
Two separate clinical evaluations must be completed as prescribed
in the stated criteria. The second may be conducted no sooner
than two hours after the first. If any evidence of brain function
is elicited during either examination, the patient does not ful-
fill the criteria and cannot be certified dead. Specific details
relevant to the examination process include:
True decorticate or decerebrate posturing indicates brain stem
function and excludes the diagnosis of brain death. However, complex
muscle movements resembling decerebrate posturing but emanating
from high spinal cord reflexes have been reported. Simple and complex
spinal cord reflexes are often preserved in brain death and, being ir-
relevant to its diagnosis, are therefore not tested. Shivering
indicates function of the temperature regulating center in the
hypothalamus and also rules out the diagnosis of brain death.
1. The pupils need not be equal or dilated but must be non-
reactive to light stimulation. The pupillary reflex may
be unreliable after the use of scopolamine, opiates, neuro-
muscular blocking agents, atropine, mydriatic eye drops,
glutethemide and in the presence of eye trauma or disease,
e.g. lens cataracts. The cilio-spinal reflex is not in-
cluded in this testing.
2. The corneal reflex may be absent due to pre-existing
severe facial weakness.
3. Painful stimuli are administered over the areas of cranial
nerve distribution and not peripherally where spinal cord
reflexes may be active.
4. Function of the glossopharyngeal and vagus nerves and their
brainstem nuclei is tested through insertion of a pharyngeal
and endotracheal suction catheter. Any gagging or coughinq
indicates remaining brainstem function.
5. The dolls eye phenomenon is tested through rapid head turning
from side to side. If resulting in eye movement, this in-
dicates remaining brainstem function.
6. The volume of ice cold water used for caloric stimulation
should be 50 ml given with the patient's head at 30 degrees
•elevation slowly into each external ear canal free of
680
cerumen. This stimulus must be followed by several minutes
of observation for any movement of the eyes. Pre-existing
labyrinthine disease may abolish this reflex as might
sedatives, anticholinergics, anticonvulsives, tricyclic
antidepressants and ototoxic effect of certain antibiotics.
The apnea test is most important. The absence of spontaneous
breathing tested during disconnection from the ventilator in
the absence of muscle relaxants, necessitates documented PaCOZ
above 60 torr and arterial pH below 7.30. If a history sug-
gestive of dependence on a hypoxic stimulus for ventilation
(e.g. a COPD patient) is present, the Pa02 at the end of the
test must be less than 50 torr. Otherwise, an endotracheal
catheter with a 3-4 1/min 02 flow may be used to avoid cardiac
arrest due to hypoxemia, of particular importance in patients
considered candidates for organ donation.
A single isoelectric electroencephalogram (EEG) is required.
This EEG is usually obtained after the first complete clinical
examination without identified brain activity. Technical
guidelines for recording the EEG to insure maximal machine
sensitivity have been established by and are the responsibility
of the Department of Neurology. The interpretation of the EEG
as isoelectric must be made by an attending staff neurologist
or Neurology Resident who has completed the EEG Rotation
and made available in writing before death certification can be
completed. If the EEG is not isoelectric, the patient does not
fulfill the necessary criteria and cannot be certified dead.
If recorded activity is suspected to be of muscular rather than
cortical origin, a muscle relaxant may be used for clarif-
ication. However, the effect of utilized muscle relaxants must
be worn off or reversed prior to the second clinical eval-
uation of brain function.
Inactivity of the vagus nerve nuclei is inferred from unrespons-
iveness of the heart rate to an intravenous atropine bolus.
The abnormalities observed during the performed brain death
evaluation should be noted on the check list. For instance,
bizarre, complex arm movements are occasionally observed and
may necessitate vertebral arteriography to rule out sustained
function of the brain stem.
CERTIFICATION
After the above diagnostic criteria have been completed, showing
no evidence of continuing brain activity, the patient shall be
certified dead. Such certification must be made by two physicians,
licensed by the State of Pennsylvania. Members of the trans-
plantation team may not be involved in death certification of
a brain dead organ donor.
Brain death certification is equivalent to the pronouncement of
death and the time documented for this certification is considered
the time of death to be used for all legal matters including the
Death Certificate issued by the hospital.
681
•The pronouncement of death i s by 1 aw a medical act. Therefore,
consent is not required nor is it to be requested from the next-
of-kin. However, the patient's family must have full information
concerning this certification process.
In those cases wherein the Coroner has jurisdiction, his permission
is not required for the death certification process or termination
of medical therapy. However, the Coroner's consent must be obtained
for removal of organs for transplantation.
When a brain dead donor of organs is transferred to PUH and Cert-
ification of brain death is made at the referring hospital, the
referring institution will send a copy of the Death Certificate.
This document will be made part of the donor record.
When organs are to be removed from a brain dead donor for the
purposes of transplantations, death certification must be com-
pleted prior to removal. Removal of organs for transplantation
must be preceded by consent from the next-of-kin (PUH Form No 874
or transferring hospital's equivalent form) unless the deceased
has legally certified such donation. When transferred
from another hospital, the donor body shall be placed in the
ICU unless taken directly to the Operating Room and the Admit-
ting Department will be notified.
A donor number will be assigned by the Admitting Department to each
donor body received by this hospital. The donor acceptance process
will not involve admission to the hospital. The donor number will be
utilized for the coordination of medical documentation relating to
the donor body and appropriate expense charges.
Those hospital policies and procedures concerning matters relevant
to any deceased patient (i.e., death, autopsy and coroner cases,
Policy #4001, etc.) apply equally to these patients after com-
pletion of the certification process and removal of all medical
therapy or life support devices.
Members of the Critical Care Medicine Program are available at
all times for the interpretation of this policy and the com-
pletion of the certification form.
SIGNED: D. L. Stickler
ORIGINAL: March, 1982
REVIEW MONTH:
MEDICAL STAFF REVIEW:
ICU Subcommittee: November, 1982
Patient Care Committee: December, 1982
Medical Executive Committee: February, 1983
Legal Review: November, 1982
SPONSOR: Assistant Director
DISTRIBUTION: A, B, D, G (G:ICU)
682
In, Principles of Critical Care Medicine (Grenvik A, Shoemaker W, et al ,
editors). Philadelphia, W.B. Saunders, in press, 1983.
Final Manuscript
March 22, 1983
BRAIN DEATH AND PERMANENTLY LOST CONSCIOUSNESS
By Ake Grenvik, MD
Professor of Anesthesiology and Surgery
Director, CCM Training Program
University Health Center of Pittsburgh
Pittsburgh, Pennsylvania 15261
683
BRAIN DEATH
Both the medical and legal professions traditionally have
equated death of the patient with irreversible cessation of
respiratory and cardiovascular functions. However, since the 1970' s,
legislation has attempted to define death as the irreversible
cessation of all brain function, i.e. brain death (1) . Thus,
irreversible cardiac arrest, which can be treated by insertion of an
artificial heart or cardiac transplantation, leads to death of the
individual only when brain function ceases.
The clinical definition of brain death is the permanent loss of
all integrated neuronal brain functions (2, 3). The term integrated
is important since recovery of some metabolic and electrical activity
in the brain following even 60 minutes of total ischemia has been
demonstrated experimentally (4) . It is also important to realize that
there is a difference between cerebral death (18) and brain death (7) :
in the former, parts or all of the brainstem, pons, midbrain and
cerebellum can still function; in the latter, all brain structures
above the foramen magnum have irreversibly ceased to function. So
far, only brain death has been medically and legally equated with
death. Once there is medical proof that all brain function has
irreversibly ceased, both ethical and religious viewpoints (5, 6) ,
support death certification and cessation of all treatment.
Specific criteria for determining brain death have been
independently developed by many different groups (3, 7, 8). While
these guidelines differ regarding individual tests recommended, all
require a detailed, careful neurologic examination that usually
includes an electroencephalogram (EBG) . Repeat evaluations may or may
not be demanded but re-examination after specified time intervals is
usually recommended. Suggested intervals range from 30 minutes to 24
hours and often vary with the etiology of coma (7-12, 18-21) . On the
other hand, brain death may be certified after a single examination in
patients with a known cause for irreversible and complete loss of all
brain function (3, 22, 12, 14, 17) .
Recent guidelines from the President's Commission for the Study
of Ethical Problems in Medicine and Biomedical and Behavioral Research
include two statements concerning the criteria for determination of
death : A) An individual with irreversible cessation of circulatory
and respiratory function is dead; and B) An individual with
irreversible cessation of all functions of the entire brain, including
the brainstem, is dead (30) . However, further analysis of these two
statements indicates that irreversible cessation of brainstem function
is the crucial issue in both. In a patient with discontinued heart
beats, cessation of the function of the respiratory center in the
brainstem is necessary to stop spontaneous breathing in order to meet
the criteria of death. A patient with high cervical spinal cord
injury, is an exception to this general rule.
In patients supported by mechanical ventilation cardiac arrest
usually occurs within 72 hours of brain death (18, 22-24) . However, a
recent publication (25) reports a patient with verified brain death,
maintained for 68 days on mechanical ventilation, before cardiac
arrest finally occurred. Theoretically, it is possible for
extracranial organs in a brain-dead body to function indefinitely,
until old age wears out the heart. In other words continued intensive
684
therapy of brain dead bodies, if generally applied, could effectively
drain our medical and economical resources. Nonetheless, temporary
continuation of intensive therapy after certification of brain death
is still indicated in two situations: when removal of organs is to
take place for transplantation purposes and when the brain dead
individual is a pregnant female with a viable fetus (26) .
The criteria for determination of death based on irreversible
cessation of all brain function, listed in the guidelines by the
President's Commission (30), require documentation that: 1) cerebral
and brainstem functions are absent; 2) this condition is irreversible
which necessitates known cause of the condition and exclusion of the
possibility of recovery; and 3) the cessation of all brain functions
persists for an appropriate period of observation and/or trial of
ier3Tto' avoid confusion between brain death and the so-called
persistent vegetative states (31), the President's Commission
guidelines (30) advise that the criteria physicians use in determining
that death has occurred should 1) eliminate errors in classifying . a
living individual as dead; 2) allow as few errors as possible in
classifying a dead body as alive; 3) allow a determination to be made
without unreasonable delay; 4) be adaptable to a variety of clinical
situations; and 5) be explicit and accessible to verification.
It is obvious from the above that both cortical and brainstem
functions must be cautiously examined and the need for this clearly
stated in any criteria adopted for determination of brain death. Most
causes of brain death (Table 1) are demonstratable on computed
tomography. However, total life-support should continue while
attempts are made to identify any reversible etiology of depressed
brain function. A hospital's policy for evaluation and certification
of brain death must require that the patient be observed and treated
for potentially correctable abnormalities with seemingly absent brain
function. Conditions which may significantly contribute to absent
brain function include hypovolemia, hypoxemia, hypotension,
hypothermia, any form of shock, and presence of central nervous system
depressants, such as sedatives, narcotics, anticonvulsants,
anesthetics or alcohol.
If a toxic, metabolic, pharmacologic, infectious or other cause
of potentially reversible coma is identified, the brain death
certification process must be suspended while appropriate therapy is
instituted or continued. For instance, deep hypothermia, especially
in combination with drug overdose (33) or acute alcohol intoxication
(34), is a condition which has been mistaken for death but careful
resuscitation has resulted in survival. Further, different forms of
shock, if present, will aggravate any co-existing <frebral
dysfunction, e.g. in multiple injury (19) and must therefore be
vigorously treated before brain death evaluation takes place (3) .
When drugs may be implicated by the history or physical
examination as a possible etiology of depressed brain functi°n'
detailed toxic screening tests are indicated. If alcohol has been
ingested, the synergistic effect between alcohol and such drugs must
be considered and blood alcohol levels obtained as well. Sedative
drugs known to be associated with an isoelectric EEG include
barbiturates, methaqualone, diazepam, mecloqualone, meprobamate and
tricholorethylene (32) . Blood levels of such agents must be absent or
685
below therapeutic range before brain death evaluation can be
performed. However, drug metabolism and excretion may be very slow in
brain dead patients, resulting in several days of continued futile
therapy in some cases, e.g. when administration of large doses of
barbiturates has been used for control of intracranial hypertension.
In such cases, we utilize documentation of complete absence of
cerebral blood flow as the ultimate criterion of brain death. This
can most easily be done through bilateral internal carotid and
vertebral arteriography but radionuclide cerebral imaging has recently
been demonstrated as a less complicated procedure of similar value
which can be performed at the bedside in the ICU (35) .
The criteria for brain death used at Presbyterian-University
Hospital (PUH) in Pittsburgh (Figure 1 and Appendix) include complete
absence of cerebral and brainstem activity on two clinical
examinations, performed at least two hours apart, plus a single,
maximally sensitive, isoelectric EEG (27) . This EEG must be recorded
with and without auditory stimulation for a minimum of 30 minutes and
at least part of this test must use an amplification factor of two
microvolts per millimeter. The EEG is usually performed between the
first and second clinical examinations. Neuromuscular blockade with
succinylcholine , pancuronium or similar agents may be used to abolish
muscle artifacts which interfere with the EEG tracing but the muscle
relaxing effects of these agents must be absent before the subsequent
clinical examination. This can easily be tested with an electric
nerve stimulator, of the type routinely used in anesthesiology.
The clinical part of the evaluation is a standardized
neurological examination of cranial nerve activity and an appropriate
apnea test to detect signs of spontaneous breathing. If there is any
sign of brain function during either clinical examination, death
cannot be certified.
Normally, painful stimuli are administered over the areas of
cranial nerve distribution rather than peripherally, since spinal cord
neurons may remain viable after brain function has ceased (20, 22).
True decorticate or decerebrate posturing indicates brainstem function
and therefore excludes the diagnosis of brain death. However, complex
muscle movements resembling decerebrate posturing but emanating from
high spinal cord areas have been reported (3, 20) . A simultaneous EEG
recording may be useful in confirming that cortical structures are not
involved in such movements although an isoelectric EEG does not
necessarily exclude minimal function of the brainstem, pons and
midbrain, known to be responsible for certain primitive reflexes e.g.
in newborns. Although simple and complex spinal cord reflexes are
often preserved in brain death, they are irrelevant to its diagnosis
and therefore not tested. However, shivering indicates function of
the temperature regulating center in the hypothalamus and rules out
the diagnosis of brain death.
The pupils need not be equal or dilated but must be nonreactive
to light stimulation. However, absence of the pupillary reflex is
nondiagnostic after administration of scopolamine, opiates,
neuromuscular blocking agents, atropine, mydriatic eye drops or
glutethemide as well as in the presence of eye trauma or disease, e.g.
lens cataract. The ciliospinal reflex is not included in this
testing, since it is not a cranial nerve reflex. The corneal reflex,
23-029 0-83-44
686
cm the other hand, is tested but may be absent due to pre-existing and
severe facial weakness.
Function of the glossopharyngeal and vagus nerves and their
brainstem nuclei is tested through insertion of a pharyngeal and
endotracheal catheter. Any gagging or coughing indicates" brainstem
function. The doll's eye phenomenon is tested by rapidly turning the
head from side to side and any eye movement indicates brainstem
function. This test must be used cautiously, since it may excerbate
any pre-existing cervical spine injury. Similarly, testing the ocular
response to irrigation of the ears with ice water may be
contraindicated by injuries to the inner ear. When this test is
undertaken, the patient's head should be at 30 elevation and 50 ml of
ice water are injected slowly into each external ear canal, which must
be free of cerumen. This stimulus should be followed by several
minutes of observation for eye movement. Pre-existing labyrinthine
disease may abolish this reflex as may sedatives, anticholinergics,
anticonvulsives, tricyclic antidepressants and the ototoxic effect of
certain antibiotics.
The apnea test is extremely important. Apnea is defined as the
absence of spontaneous breathing during disconnection from the
ventilator with an arterial carbon dioxide tension greater than 60
torr and an arterial pH below 7.30 at the end of the test. Of course,
this necessitates absence of muscle relaxants. If the patient's
history suggests dependence on a hypoxic stimulus for ventilation such
as in chronic obstructive pulmonary disease (COPD) , the arterial
oxygen tension at the end of the test must be less than 50 torr.
Otherwise, an endotracheal catheter with an oxygen flow of 3 to 4
L/min may be used to avoid cardiac arrest due to hypoxemia which is a
complication of particular importance in patients being considered as
organ donors.
The most recent problem encountered in brain death certification
is the transport delay caused by conflicting criteria among hospitals
transferring dead patients for multiple organ harvest and
transplantation (29) . For transplantation of hearts, kidneys or
livers, donor organs may be retrieved at a distance from the
transplant center. Kidneys are kept viable in hypothermia with
specially designed perfusion machines. Hearts and livers are chilled
by perfusion of hyperosmolar solutions at +4 C and transported cold,
sometimes thousands of miles by charter or private jet air craft.
While ischemia time is variably prolonged, risks to donor organs are
generally acceptable. However, in combined transplantation of heart
and lungs, the lungs are more prone to ischemic injury. For such
transplantation, ischemia time is minimized by harvesting organs at
the transplant center. When a brain dead donor is transferred to PUH
in Pittsburgh, death certification must be performed at the referring
hospital. Brain dead donors are accepted only from hospitals where
criteria of brain death have been scrutinized in advance by our staff
and found acceptable. The body is registered at the hospital by
number in contrast to being admitted and is placed in the ICU for full
cardiopulmonary support. This procedure permits removal of the heart
and lungs during optimal conditions utilizing cardiopulmonary bypass.
When the heart and lungs have been removed, hypothermic perfusion is
continued during removal of liver and kidneys. Thus, the technique
described permits optimal procurement of multiple organs for
687
transplantation. However, we find strict adherence to carefully
written and previously approved policies and procedures to be of
greatest importance for this activity, especially since the medical
legal responsibilities of the receiving hospital are presently
unclear, should brain death certification of the transferred donor for
any reason be erroneous as has happened in the past (20) .
PERMANENTLY LOST CONSCIOUSNESS
Permanently lost consciousness denotes a condition between life
and death. Such individuals are not brain dead nor able to return to
a cognizant life. There is severe neurological dysfunction with only
minimal persisting brain activity. These conditions must be excluded
from certain medullo-pontine lesions causing the so-called locked in
syndrome, also referred to as akinetic mutism, paralytic akinesia and
cerebro- medullospinal disconnection. In the latter condition, some
mental awareness may be preserved and significant cranial nerve
dysfunction exists but voluntary muscle movements are absent (38-40) .
Permanent unconsciousness occurs in five different conditions:
1) persistent vegetative states; 2) coma after brain injury or hypoxia
without brainstem function; 3) endstate degenerative brain disease
(e.g. Jacob-Creutzfeldt's and Alzheimer's diseases); 4) intracranial
mass lesions; 5) congenital brain hypoplasia (anencephaly) (44) .
However, permanent unconsciousness is often referred to by other
terms. Thus, Ingvar et al (41) describe what they call the apallic
syndrome. This term was first introduced by Kretschmer in 1940 (45) ,
pallium meaning the mantle of the telencephalon, i.e. the cerebral
cortex. Mollaret and Goulon in 1959 (33) coined the expression coma
prolonge. Jennett and Plum in 1972 (31) referred to this as the
persistent vegetative state and Brier ly et al in 1976 (46) called it
neocortical death. Finally, Korein in 1978 (18) used the expression
cerebral death which is not identical to brain death, since the
midbrain, pons, brainstem and cerebellum partially or totally are
intact. However, for all practical purposes, the above terms can be
considered synonymous.
In their publication of 1978, Ingvar et al indicate that these
apallic syndrome patients after a few weeks become arousable whereas
comatose patients by definition are nonarousable . Thus, these
patients, while no longer in coma, nonetheless are unconscious. All
higher functions are absent such as speech, voluntary movements,
emotions and memory. Brainstem reflexes on the other hand are usually
present such as spontaneous breathing. Although the patients are
arousable, they respond to stimuli with primitive functions only, such
as eye opening, chewing and changes in respiratory rate and rhythm.
On electroencephalography, electrical activity is typically present
but severely depressed.
The etiology of the apallic syndrome is usually cerebral anoxia
which may be caused, for instance, by global ischemia in prolonged
cardiac arrest, cerebral hypoperfusion in shock conditions or
complete absence of cerebral blood flow during periods of intracranial
hypertension. While the sensitive neurons in the neocortex die
secondary to the above, brainstem function may be surprisingly well
retained. With time, there is severe cortical atrophy with
enlargement of the ventricular system. Clinically, such conditions
688
are demonstrable at computerized tomography and ultrasonic examination
of the brain as a gigantic ventricular system with a thin layer of
tissue left, where normally the cerebral cortex would be found.
The characteristics of permanently lost consciousness has been
excellently described as follows: "Personality, memory, purpose of
action, social interaction and emotional states are gone. What
remains is a bodily reminder of a person who once was and might yet
have been. Only vegetative functions and reflexes persist. If food
is supplied, the gut functions and uncontrolled evacuation occurs; the
kidneys make urine and the bladder is incontinent; the heart, lungs
and blood vessels continue to move air and blood; nutrients are
distributed in the body and C02 and 02 are exchanged." (44)
Unfortunately, there is a common misunderstanding in today's
medical society that as long as there is any sign of life, every
patient in the intensive care unit must be treated maximally.
However, as Childress describes "optimal care does not always mean
maximal treatment. Caring continues even when the patient is allowed
to die" (43) . Childress continues: "every person has the right to
die, i.e. the right of noninterference, but not the right to be killed
e.g. through a claim to another person's assistance. For the
physician, the benefit to the patient is paramount; treatment must be
in the patient's best interest."
Veatch (42) suggests that the whole brain death concept is
outmoded. In his words, "death is the irreversible loss of what is
essentially significant to the nature of man, including the capacity:
to integrate bodily function, for rationality, to experience, and for
social interaction." In 1981, the AMA Judicial Council indeed
expressed as its opinion that "Where a terminally ill patient's coma
is beyond doubt irreversible and there are adequate safeguards to
confirm the accuracy of the diagnosis, all means of life support may
be discontinued." Through clinical examination, cerebral
arteriography, CT scanning and ultrasonic examination of the brain, it
is possible to demonstrate total loss of the cortical layers and thus
verify the irreversibility of the patient's unconsciousness, although
several weeks must pass before such documentation can take place. In
these conditions, life sustaining therapy is no longer of any benefit
to the patient and thus not indicated. If not indicated, such therapy
should be withdrawn just as all other no longer indicated therapy is
discontinued in clinical practice. Based on this important medical
principle, there is no significant difference between withholding and
withdrawing therapy.
Typical examples of life sustaining therapy include mechanical
ventilation, vasopressor infusion and use of intra-aortic balloon
pumping. However, most discussion has concentrated on the use of
mechanical ventilation and "pulling the plug" of the ventilator in
these conditions. Abrupt discontinuation of life supporting therapy
such as mechanical ventilation might be interpreted as an act
committed with intent to kill. Therefore, in Pittsburgh, we have
developed a different technique referred to as "terminal weaning"
(47) . It is important to understand that when death follows terminal
weaning, the patient dies from natural causes due to his or her lethal
disease and not from an act of killing by the responsible physician.
The difference between terminal weaning and regular weaning from
life supporting therapy is that terminal weaning proceeds in spite of
689
deteriorating vital signs and other monitored variables. For
instance, during terminal weaning from mechanical ventilation, we
continue to analyze arterial blood gases in order to know how close
the patient is to a final cardiac arrest or whether the patient may be
able to maintain his or her own spontaneous breathing sufficiently for
a temporary period of time. (Compare the situation of Karen Ann
Quinlan when her mechanical ventilation was discontinued in 1976. She
is still breathing spontaneously after seven years, although in a
permanently unconscious state.)
Terminal weaning proceeds relatively quickly, over several hours
rather than several days. Many patients die in this phase. A few
survive to the point of spontaneous breathing and occasionally we are
even able to extubate these patients. Some need to remain intubated
to avoid sudden airway obstruction which again causes a relatively
abrupt death rather than the intended quiet and peaceful death taking
place over a few hours. Sometimes, a tracheostomy has been performed
to avoid the airway obstruction/suffocation type of death. However,
tracheostomy is now avoided, as this prolongation of life is of no
benefit to the patient.
In those patients whose breathing pattern includes gasping or
other signs that are distressful to observers, we provide increments
of morphine intravenously, 1-2 mg at a time. The purpose is to
decrease reflex response to hypoxia and also to reduce metabolism and
thus oxygen demand. This form of therapy provides comfort to the
relatives who wish to see their loved one die quietly without "signs
of suffering". Further, it has a comforting effect on the personnel
in the ICU. Arterial blood gas analyses are continued so that the
attending physician will be better able to reasonably predict the
moment of death, thus providing reliable guidance to present family
members.
Once the decision has been made for limited therapy related only
to hygenic care and comfort, it is important that one does not
continue already started treatment which is no longer indicated. For
instance, continuance in this phase of mechanical ventilation may very
well postpone the moment of death by several days and occasionally
weeks. This might give the relatives the impression that the
physicians were mistaken in their information to them regarding the
prognosis of the patient's condition. Further, many relatives,
especially those who remain continuously in the ICU waiting room to be
close to their dying relative, may develop sleep deprivation,
irritation, disappointment, anger and even hostility against the
hospital and its personnel, including the attending physician.
However, if the physician remains confident in his overall analysis of
the patient's condition and prognosis, having already in detail
diagnosed the patient's primary disease and potential complications as
well as carefully evaluated the related prognosis, he will indeed be
able to provide the patient with this important opportunity to die
peacefully, usually within a few hours, through the terminal weaning
procedure. The relatives will then leave the institution grateful and
satisfied. They will be aware of two things. First, everything
possible was done for their loved one. Second, when it became obvious
that there was no reasonable possibility for survival, all forms of
treatment no longer indicated were discontinued or gradually withdrawn
to finally permit the patient to die with dignity. Unfortunately,
690
continued life sustaining therapy in these futile conditions is
cannon, although it is exhausting and frustrating to relatives,
exasperating to personnel, wasteful of resources and expensive to the
nation.
The following steps are taken at Presbyterian-University Hospital
in Pittsburgh during terminal weaning:
1. Continual respectful /hygenic care is provided throughout.
2. Continued close monitoring for prediction of monent of
death, i.e. cardiac arrest.
3. The weaning proceeds over hours rather than days, regardless
of deteriorating variables, e.g. arterial blood gases.
4. If disturbing gasping occurs, morphine sulfate, 1-2 mg TV,
is given to decrease hypoxic reflex response, metabolism and
oxygen demand and is repeated as indicated.
5. If airway obstruction is not expected, the patient is
extubated once weaned off mechanical ventilation and
breathing spontaneously.
6. If maintaining his airway without severe obstruction, the
patient is discharged from the ICU to a private room in a
regular ward where relatives may remain continuously with
the dying patient.
7. The responsible physician remains in close conmunication
with the relatives throughout.
8. The patient may die in any phase of the above and the
relatives should be so informed in advance.
Pain and other forms of suffering, including the psychological
aspects of life terminating in an ICU, is a threat especially to the
elderly in our society. To some of them, the ICU becomes a modern
torture chamber, where young physicians consider death their worst
enemy and do not appreciate that it may be the old man's friend, when
he has reached a point where he may indeed wish to die. Today,
critical care physicians, nurses and other health care providers are
extremely good at keeping terminally ill patients alive in the ICU
with all modern forms of medical management, utilizing electronic and
computerized equipment. However, the problem is that all that is done
in many of these cases is to prolong the patient's dying.
When intensive care units were implemented many years ago, the
emphasis was on resuscitation and continued life support. It has
become increasingly obvious that diagnostic pursuit and determination
of prognosis, especially as it relates to the brain, is of greatest
importance in this situation. Critical care physicians will fail to
serve mankind optimally if the wisdom of continued support is not
always carefully considered in each case. It is definitely wrong to
believe that every condition is curable. It is also wrong to continue
life sustaining therapy of all ICU patients until cardiac arrest
occurs and even worse to always perform cardiopulmonary resuscitation
on all patients without distinction. Many modern physicans seem to
have lost the understanding that death is a fact of life and will
always occur. Some of us act as if life were eternal or at least may
always be meaningfully prolonged. By attempting prolongation
indiscriminately, much unnecessary suffering may occur among close
family members. Fortunately, in persistent vegetative states these
permanently unconscious patients are beyond suffering. This is true
691
because these patients cannot experience suffering without a
functioning cerebral cortex.
Physicians have the duty to sustain life and relieve suffering.
However, with some dying patients, these duties will conflict and the
choice to forego life-sustaining therapy in order to relieve suffering
is justified (36) . Since the patient with permanently lost
consciousness is unable to suffer, it is important to consider the
suffering of family members which takes place with an unduely
prolonged death process. The participation of family members in the
decision making process is necessary to maintain the trusting
patient- family-physician relationship, once the patient is no longer
able to take part in this process. Hesitation on the family members'
part should be met with additional sensitive discussions and
continued education, as indicated, concerning the patient's condition
and the implications of changes in his or her status.
We have also seen cases in which relatives have requested
withdrawal of treatment when the involved physicians consider the
patient to have a sufficient chance of survival to warrant continued
life support. In one extreme example, both the referring physicians
and the relatives were led to believe that the patient had already
succumbed due to irreversible cessation of all brain function. This
was an 18-year-old man, admitted to our ICU with multiple injuries,
including brain contusion following a severe automobile accident. He
was referred from another hospital for the sole purpose of kidney
donation with consent forms for removal of these organs already signed
by the parents. However, since the patient was in hypovolemic shock,
and had rudimentary cranial nerve reflexes, he did not meet our brain
death criteria and total support was provided. He responded
surprisingly well to vigorous resuscitation, including aggressive
treatment of his hypovolemia, and was discharged from the hospital
after two months with only relatively minor residual neurological
deficits of right hemiparesis and some impairment of higher cognitive
functions (20) .
Initial aggressiveness, rapid diagnostic pursuit of underlying
disease and/or all different injuries in trauma victims, alertness
towards potential complications, and repeated evaluation of prognosis
following a significant period of maximal therapy, are all important
factors which must be considered before a decision is made to withdraw
any therapy. Nonetheless, such decision should not be further delayed
when the needed evidence is at hand that continued treatment is
futile. Under these conditions, a shorter life and its satisfactions
are expected to outweigh the appeal of prolonged life limited to an
intensive care unit. However, guidelines must protect against
untimely death, caused by temporary depression of the patient,
erroneous decision and other flaws in the decision making process
(36).
692
TABLE 1
Patients certified brain dead 1970-1976
Presbyterian-University Hospital
Pittsburgh, Pennsylvania
Age
Etiology No. (%) Range Mean
Cerebral bleeding
Trauma
Postresuscitation
Vascular occlusion
Tumor
Miscellaneous
Total
This table shows distribution of causes of brain death in 176 consecutive
cases at Presbyterian-University Hospital in Pittsburgh (20) .
70
(39.8)
58
(32.9)
20
(11.4)
14
(8.0)
6
(3.4)
8
(4.5)
76
(100.0)
18-76
44
11-65
30
17-89
48
18-76
44
22-62
48
16-54
43
11-89
41
693
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696
Mr. Gore. Thank you very much, doctor.
Our next witness is Dr. Richard Rettig, professor and chairman
of the Department of Social Sciences at the Illinois Institute of
Technology in Chicago.
Dr. Rettig, welcome.
STATEMENT OF DR. RICHARD A. RETTIG, PROFESSOR AND
CHAIRMAN, DEPARTMENT OF SOCIAL SCIENCES, ILLINOIS IN-
STITUTE OF TECHNOLOGY
Dr. Rettig. Thank you, Mr. Chairman.
I am at the Illinois Institute of Technology, as you indicated. 1
was with the Rand Corporation. With Jerome Aroesty at the Rand
Corporation, I have been engaged in the past 15 months in a study
of kidney transplantation and organ procurement.
My remarks today are based on that study. They represent the
personal views of Dr. Aroesty and myself and not necessarily the
views of either the Illinois Institute of Technology or the Rand Cor-
poration. I will touch on some of the highlights of the study.
On July 1 of this year, the United States will mark the 10th an-
niversary of medicare coverage of end-stage renal disease. Within
the context of this hearing, I will restrict myself to the kidney di-
mension. ,. ,. , _,
That effort expended $228 million in direct medicare benefits in
1974, its first full calendar year of operation, and you heard from
Dr. Davis this morning that the estimates for 1982 will be $1.8 bil-
lion. . _ ~
The ESRD program is primarily a dialysis program. On Decem-
ber 31, 1982, HCFA reported that some 70,000 ESRD patients were
entitled to medicare benefits for both dialysis and transplantation.
They also reported that 65,000 medicare and non-medicare patients
were receiving dialysis treatments on that date, of whom it is esti-
mated 86 percent are currently entitled, 7 percent are in the initial
waiting period, and approximately 7 percent are not entitled to
mpciiC3.r6 DGriGiits.
In 1982, it was estimated that 12,000 patients were alive with a
functioning kidney transplant. HCFA reported that 5,358 trans-
plant procedures were performed in 1982. Of these, somewhat more
than 70 percent came from cadaver donors; somewhat less than 30
percent from living related donors.
For 1981, of an estimated 3,600 cadaver transplant procedures,
approximately 2,900 constituted first transplants, and approximate-
ly 700 represented retransplants; that is, second or successive
transplants following failure of an initial transplant.
Potential transplant recipients are estimated by us to be approxi-
mately 22,500 or % of the dialysis population. Of about 20,000 pa-
tients each year who currently begin treatment for permanent
kidney failure, about 8,000 are estimated to be suitable for trans-
plantation. .
Let me underline my next point, Mr. Chairman. It seems to me
the reason we are here today is that it is widely believed within
the transplant community that there is new era at hand in organ
transplantation, and all the meaning attached to this hearing
ought to be seen in light of that breakpoint that we anticipate— we
697
have not yet seen — but that breakpoint of the future from the
recent present and the past.
Survival of a transplanted cadaver kidney hovered for some time
around the 50 percent 1-year post-transplant mark. A number of
medical people in the nephrology community found that not par-
ticularly strong evidence of success. That cadaver kidney survival
rate has clearly moved up, and it is because that has moved up,
due to many factors but certainly to cyclosporine, that we are here
today.
The question then becomes, if a new era of transplantation is at
hand, what ought the Congress and the executive branch to be con-
sidering? Let me suggest the following:
First, that we set some reasonable objectives, or at least think
about some reasonable objectives. When I say set reasonable objec-
tives, I do not mean either a new statute, or new regulations. But
we think it is reasonable to double the number of kidney trans-
plant procedures over a 5-year period. This would mean, from a
base of 5,000 now, an annual increment of 1,000 new kidneys per
year so that by 1987 or 1988, transplant surgeons were performing
10,000 transplant procedures.
We are not predicting that this will happen. We think it is rea-
sonable to set these objectives and to think about the problem in
these terms.
Second, it should be recognized that there is a complex cost-
saving phenomenon that occurs within the kidney transplantation
domain, and it is sometimes at variance with those who intuitively
think that transplantation successes can eliminate the entire dialy-
sis population.
There are several reasons for this what would appear to be
modest cost savings. These reasons include the substantial front-
end costs associated both with the transplant procedure and organ
procurement that dominate the patient cost profile and mask out-
year savings.
Second, important cost savings from improved transplantation
will have a relatively modest initial effect on the much larger dial-
ysis population of the total end-stage renal disease program. So you
are getting a big purchase, at the moment, on a fairly small por-
tion of the total problem. The savings, however, will accumulate
over time, and that is a very important thing to note.
The cost effects are likely to occur in three areas. Transplant
successes may become less expensive. Data from Minnesota and
Pittsburgh suggest less initial hospitalization days and reduced fre-
quency of readmission. The variance from center to center may be
quite substantial, and these cost savings may be offset somewhat
by increased costs of medication. But that is one important source
of potential savings.
Secondly, and something that is not discussed really very exten-
sively in the literature, is the following: The cost of kidney trans-
plant failure may be expected to decline. Failure of a transplant
results in either death or return to dialysis.
In 1981, about 3,600 individuals received a cadaver transplant, as
I said earlier, about 2,900 first transplants. Of these first trans-
plants, it is estimated that 60 percent were alive with a functioning
698
transplant 1 year later, 10 percent died, and about 30 percent re-
turned to dialysis.
If transplant failure occurs and an individual does return to dial-
ysis, the cost to HCFA of unsuccessfully treating rejection is ap-
proximately $3,500. The cost of removing the failed kidney when
necessary — and it is frequently necessary — is approximately
$10,000. The additional cost of the dialysis regime ranges up to
$3,000 per year more than the normal dialysis patient.
So one would expect to cut into these costs by doing better, by
reducing the number of failures, and these cost savings are availa-
ble regardless of the scarcity or shortage of kidneys.
Third, the rate of growth of ESRD program costs will decrease
over time as patients are successfully shifted from dialysis to trans-
plantation.
Two summary points on this section: The ESRD program will
remain primarily a dialysis program, but, secondly, improved
transplantation results will have a beneficial cost effect, particular-
ly over time.
The second thing we can do is to improve organ procurement. Dr.
Prottas will address some of these issues, but I have the following
comments to make about strategies to increase the number of ca-
daver kidneys retrived and used.
First, increase the interaction of organ procurement teams with
source hospitals in a way consistent with the methodology de-
scribed by the Centers for Disease Control.
Second, it would be prudent and worthwhile to examine the rela-
tionship between those kidneys retrieved and those actually used.
Currently, 20 to 25 percent of retrieved kidneys are not used for a
variety of reasons, and attention needs to be addressed to this.
Third, we believe that the experience of CDC in the late 1970's
deserves reevaluation. I wish to make a very important point here.
Practically all interpretations of that experience point to the bene-
fits of using the CDC methodology or systematizing the process. We
believe that benefit is very important. But quite often and usually
overlooked has been the fact that the CDC experience also had a
second dimension, and that is, CDC invested additional resources
into the locations where they developed their methodology. The
point is this: If you invest more in organ procurement, you may re-
ceive more kidneys as a consequence. That proposition, to our
knowledge, has not been examined. It is a very important point.
We reimburse on a per-kidney acquired basis. That may be subopti-
mal relative to the entire program. That is about $7,000 per
kidney, on the average, is spent by HCFA. If that figure rose for
example, to $9,000 or even higher it would be worth examining
what the effect would be in more organs received on the other side.
Fourth, if the results of transplantation improve, the country
should take advantage of this through public education that dis-
seminates widely the information about this improvement. We be-
lieve that altruistic behavior in the form of voluntary donations of
kidneys may relate to the perception of the probability of success-
ful outcome from transplantation.
There was a Gallup poll taken in January of this 1983. The re-
sults were reported by the National Kidney Foundation in Febru-
ary. A national sample of 1,500 individuals showed that 49 percent
699
believed that the donation of a kidney "could extend that person's
life substantially" that is, the recipient's life; but 42 percent ex-
pressed uncertainty that receiving a kidney "might or might not"
extend that person s life.
Of those who expressed greatest confidence about the benefit, 60
percent expressed the willingness to permit the donation of their
own kidneys. For those indicating greater uncertainty about the ef-
fects of transplantation, only 36 percent expressed a willingness to
donate kidneys.
It might reasonably be expected, therefore, that if outcomes im-
prove and the perception of improved outcomes increases, a corre-
sponding increase in willingness to donate will occur.
It might further be expected, therefore, that we would witness a
shift in attitudes, intentions, and behaviors that result in increased
organ donations.
There are many qualifications to this, but the basic line of argu-
ment is that altruistic behavior is predicated on the perceived like-
lihood that the donated kidney will usefully prolong life. Public
policy should emphasize this and not prematurely deem altruism a
failure.
Fifth, and a corollary to the above, presumed consent laws
should not receive high priority. There are important ethical and
social aspects that deserve full debate. But simply as a practical
matter, it is a long, complex process to change the laws of 50
States. 1970 was when the first State adopted brain death legisla-
tion. Thirty States have done so today. Illinois is on the threshold
of doing so. New York has yet to do so.
Presumed consent laws, we anticipate, would follow that same
lengthy process. We should devote our energies more usefully to
improving the present system.
What are the policy implications?
If a new era in transplantation as a treatment for end-stage
renal disease is at hand, at least five specific policy issues deserve
attention.
First, Congress should examine the issue of reimbursing
immunosuppressive drugs used by transplant recipients for outpa-
tient services. That issue deserves very, very careful attention by
the Congress, because the current law precludes HCFA from reim-
bursing medications prescribed for the outpatient setting.
Second, Congress should eliminate the 3-year limitation on the
eligibility for benefits for the successful transplant recipient. The
initial 1972 law limited benefits to 12 months; the 1978 legislation
lengthened the time to 3 years. The legislative history is practically
nonexistent, and there is no basis in equity for patients, nor a pos-
ture of neutrality among treatments, to justify that limitation.
Third, Congress and the executive branch should examine the
proposition that increased resources invested in organ procurement
might well yield higher numbers of retrieved kidneys.
Fourth, Congress and the executive branch should recognize that
the capability of the Federal Government to administer the end-
stage renal disease program is so weak that both the Congress and
the executive branch should search for ways to promote learning
within the administratively decentralized, geographically dispersed
organ procurement and kidney transplantation system. I cannot
700
underline this more strongly. Not much help is going to come from
the Federal Government. .
In 1981, in September, before Senator Durenberger, in addressing
aspects of this program, several of us advised that the Health Care
Financing Administration should not disestablish the Office of Spe-
cial Programs and the Office of End-Stage Renal Disease. We did
not know this hearing would be held this month, but we predicted
that some hearing would be held in the future and that the admin-
istrative capability to deal with these issues should exist.
In the absence of that capability, conferences, seminars, and
learning should be nourished and encouraged wherever possible
across the country. .
Finally, I would concur with the comments made this morning
that the current institutional mechanisms for assessing the nature
and implications of new developments in medicine, like improved
transplantation, are so weak that they demand revaluation
I hope these remarks help these deliberations on this subject of
organ procurement and transportation.
Thank you. ,
[The prepared statement of Dr. Rettig follows:]
701
Testimony of
Richard A. Rettig, Ph.D.
Representative Gore, Members of the Subcommittee.
My name is Richard A. Rettig. I am Professor of Social
Sciences and Chairman of the Department of Social Sciences at'
the Illinois Institute of Technology. I am also a consultant to,
and a former employee of, the Rand Corporation. In this latter
capacity, with Dr. Jerome Aroesty of Rand, I have been engaged
for the past fifteen months in a study of kidney transplantation
and organ procurement.
My remarks today are based upon that study. They represent
the personal views of Dr. Aroesty and myself and do not necessarily
represent the view of either the Illinois Institute of Technology
or the Rand Corporation.
On July 1 of this year, the United States will mark the 10th
anniversary of Medicare coverage of end-stage renal disease. That
effort expended $228.5 million in direct Medicare benefits in 1974,
its first full calendar year of operation. Preliminary figures from
the Health Care Financing Administration show 1982 Medicare
expenditures of $1,540.1 million, and it is reasonable to expect
that the final figure- will reach $1.7 billion or higher.
The ESRD Program is primarily a dialysis program. On
December 31, 1982, HCFA reported that 70,055 ESRD patients were
entitled to Medicare benefits. HCFA also reported that a total
of 65,763 Medicare and non-Medicare patients were receiving dialysis
treatments on that date. Of this number, it is estimated that 85
percent are currently entitled to benefits, 7 percent will be
entitled after fulfilling the initial waiting period requirement ,
23-029 0-83-45
702
and 7 percent are not entitled to Medicare benefits.
In 1982, an estimated 12,000 ESRD patients were alive with
a functioning kidney transplant. HCFA reported that 5,358 transplant
procedures were performed; of these somewhat more than 70 percent
came from cadaver kidney donors and somewhat less than 30 percent
were received fron living-related donors. For 1981, of an
estimated 3,600 cadaver transplanted procedures, approximately
2,900 constituted first transplants and approximately 700 represented
retransplants (second or successive transplants following
transplant failure).
Potential transplant recipients are estimated to be 22,500,
or three-eighths of the dialysis population. Of about 20,000
patients each year who begin treatment for permanent kidney failure,
about 8,000 are estimated to be suitable for transplantation.
It is widely believed by the transplant, community today that
a new era in organ transplantation is at hand. Survival of the
transplanted cadaver kidney, which hovered around 50 percent
one-year post-transplant for a long while, has improved in
recent years. Early clinical trials on the use of Cyclosporin
have achieved one-year post-transplant kidney survival rates
of 80 percent. Patient survival has been in the 85 to 95 percent
range, one year post-transplant for 5 years now, at least in the
major transplant centers.
If a new era in transplantation is at hand, what factors
deserve attention from a Congressional and Executive branch
perspective? We recommend attention to the fol loving:
703
Set Reasonable Objectives
We believe that a reasonable objective is to double the
number of kidney transplant procedures over five years. This
means an annual increment of 1,000 transplants, from a base of more
than 5,000 in 1982, to over 10,000 in 1987. A level of 10,000
procedures annually would permit all new potential transplant
recipients to receive a kidney and perhaps would allow a reduction
in the existing pool of potential recipients.
Recognize the Complex Nature of Cost Savings
The cost savings of improved kidney transplantation, as analyzed
in several recent studies, appear more modest than one might intuitively
expect. Several factors influence this:
o Substantial front-end costs, associated with the
transplant procedure and the organ procurement costs,"
dominate first-year cost profiles for the transplant
patient. Thus, long-term cost savings to the BSRD
Program from improved transplant 'outcomes'- will be
obscured by limited short-term cost-savings.
o Important cost savings from improved transplantation have
a relatively modest initial effect on the much larger
dialysis portion of the ESRD Program. Cost savings
for individual patients may be masked by the limited
effects at the program level. But the savings are
expected to be positive and to accumulate over time.
704
Cost effects are likely to occur within three areas:
o Transplant successes may become less expensive.
Data from the University of Minnesota and the
University of Pittsburgh suggest less initial
hospitalization days and reduced frequency of
readmissions. The potential for cost savings
from these sources may vary substantially
from transplant center to center, and may be offset
sanewhat from increased costs of medication,
o The costs^kidney transplantation failure may
be expected to decline. Failure of a transplant
results in death or a return to dialysis. In
1981, 3,425 individuals received a cadaver
transplant, of whom approximately 3,000 were
first transplants. Of these first transplant
recipients, it is estimated that 10 percent died,
60 percent were -alive with a functioning kidney
at one-year post-transplant, and 30 percent
returned to dialysis. If transplant failure
occurs, and an individual returns to dialysis,
the cost to HCFA of unsuccessfully treating
rejection is approximately $3,500, the cost of
removing the failed kidney when necessary is
• approximately $10,000, and the subsequent dialysis
costs are on the average up to $3,000 more per
year than the average dialysis patient. Savings
705
from reduced costs of failure, it should be
emphasized, will become available from doing
better at transplantation and are not contingent
upon an increased supply of kidneys. .
o The rate of growth of ESRD Program costs
will decrease over time as patients are
successfully shifted from dialysis to
transplantation.
Mr. Chairman, the detailed analysis supporting these conclusions
is now being completed and will be submitted for inclusion in the
hearing record. Several general comments, however, deserve
highlighting. First, the ESRD Program will remain primarily
a dialysis program -- a large, relative successful but expensive
treatment for permanent kidney failure -- even with improved
outcomes of kidney transplantation. But improved transplantation
results, in addition to the medical benefits they bring* can
be expected to result in cost savings to the U.S. Government and
to the nation, savings which will accumulate over time.
Improve Organ Procurement
What strategies can be pursued to increase the number of
cadaver kidneys retrieved and used? First, the interaction of organ
procurement teams with source hospitals can be increased in a
systematic way. The most widely known "system" is the Centers
for Disease Control (CDC) methodology, however modified,
developed in the late 1970s.
706
Second, the efficiency of use of retrieved kidneys deserves
careful analysis. Currently, 20 to 25 percent of retrieved kidneys
are not used for a variety of reasons. Attention needs to be'
focused on the prospects for increasing the ratio of kidneys
used to those retrieved.
Third, the CDC experience in the late 1970s deserves revaluation.
Practically all interpretations of this experience point to the benefits
of using the CDC methodology, or of systematizing the procurement
process, in increasing the number of retrieved kidneys. Overlooked
has been the fact that the CDC experience involved increasing the
procurement resources expended in two areas of the country. Given
the successful CDC effect, a reasonable inference is that increased
investment in procurement may also result in increased numbers of
kidneys retrieved. If so, reimbursing procurement on the basis
of the current cost of each retrieved kidney may limit the capacity
of organ procurement teams and thus limit the volume of retrieved
kidneys.
Fourth, if the results of transplantation improve, the country
should take advantage of this through public education that
disseminates widely the information about this improvement.
Altruistic behavior in the form of voluntary donation of kidneys
may relate to the perception of the probability of a successful
outcome from transplantation. A recent Gallup Poll showed, for
a national sample of 1,488 individuals, that 49 percent believed
that the donation of. a kidney "can extend that person's life
substantially" but that 42 percent expressed uncertainty--
707
receiving a kidney "might or might not extend that persons life."
Of those who expressed least uncertainty about the benefit, 60
percent expressed the willingness to permit the donation of their
own kidneys; for those indicating greater uncertainty about the
effects of transplantation, however, only 36 percent expressed
willingness to donate their own kidneys.
It might reasonably be expected, therefore that if outcomes
improve, and the perception of improved outcomes increase, that a
corresponding increase in willingness to donate will occur. It
might further be expected, then, that a shift in attitudes-
intentions-behavior will occur that will result in increased organ
donations. Many qualifications are interspersed in this line
of reasoning, but the argument basically assumes that altruistic
behavior is related to the perceived likelihood that donated
kidneys will successfully prolong life. Public policy should
emphasize this and not prematurely deem altruism a failure.
Fifth, and a corollary to the above, presumed consent laws
should not receive high priority. We believe important ethical
and social policy issues are at stake in this issue and these
deserve thorough public discussion and debate. These issues
notwithstanding, and simply as a practical matter.it is reasonable
to assume that it will require a decade or more to enact such laws
in the fifty states. It was in 1970, after all, that Kansas
adopted the first brain death statute. Thirteen years later,
approximately 30 states have done so, Illinois appears on the
threshhold of doing so and New York has not done so. A long,
708
complex social process is required to introduce such a major change
in the legal regime govering organ donation. Immediate energies can
better be devoted to the improved performance of the existing system.
Policy Implications
If a new era in transplantation as a treatment for end-stage renal
disease is at hand, what specific policy issues require attention.
At lease five suggest themself:
o Congress should examine the issue of reimbursing
irrmunQ- suppressive drugs usedly transplant
recipients for "outpatient services."
o Congress should eliminate the three year limit on
eligibility for benefits of successful transplant
recipients.
o Congress and the Executive Branch should examine the
propositon that increased resouces invested in organ
procurement might well yield higher numbers of
retreived kidneys.
o Congress and the Executive branch should recognize
that the capability of the federal government
to administer the End-Stage .Renal Disease Program is
so weak that they should search for ways to promote
learning within the the administratively decentralized,
geographically dispersed organ procurement and
kidney transplant system.
0 Finally, Congress and the Executive branch should
acknowledge that the institutional mechanism for
assessing the nature and implications of new developments
like improved immuno-suppressive drugs are so weak
that they demand reevaluation.
1 hope these remarks help your deliberations on this subject
of organ procurement and transplantation.
709
Mr. Gore. Well, they surely do, and we will have some questions.
We will have two more witnesses first.
We have a vote on the floor, so with your indulgence, we will
recess for approximately 10 minutes, and then we will come back
in and finish the hearing.
[Short recess taken.]
Mr. Gore. The subcommittee will come back to order.
Our next witness is Dr. Jeffrey Prottas, visiting professor at the
Center for Health Policy Analysis and Research, Florence Heller
Graduate School, Brandeis University.
Dr. Prottas, am I pronouncing your name correctly?
Mr. Prottas. You are.
Mr. Gore. Good. I am doing well today.
Without objection, we have already put your statement in the
record. If you care to summarize your statement, we would appreci-
ate it because we are running short on time, but we are delighted
to have you here, and we look forward to hearing your testimony,
so please proceed.
STATEMENT OF DR. JEFFREY M. PROTTAS, VISITING PROFESSOR,
CENTER FOR HEALTH POLICY ANALYSIS AND RESEARCH,
FLORENCE HELLER GRADUATE SCHOOL, BRANDEIS UNIVERSI-
TY
Dr. Prottas. I will summarize the key points of my testimony.
First of all, I would like to say the testimony is based on more
than 3 years of research into the end-stage renal disease program.
The last 2 years of that research have been an evaluation of the
Nation's organ procurement system.
In the course of that research, which is almost completed, I will
have visited or surveyed every organ procurement agency in the
country and analyzed the financial statements of each agency. This
research has been funded by HCFA.
The work originated in part in HCFA's appreciation of the fact
that there is a chronic shortage of cadaveric organs for transplan-
tation. The goal of the research, therefore, has been to recommend
reforms in the organ procurement system so as to increase the
number of organs obtained each year.
A secondary goal has been to identify cost-effective approaches to
organ procurement.
The Nation's organ procurement system consists of approximate-
ly 120 OPA's — that is, organ procurement agencies. Thirty-four of
these are independent agencies, not part of a transplant hospital.
The remaining 85 or so are hospital-based agencies.
There is very great variation among OPA's in terms of size and
effectiveness. On average, the independent agencies are larger and
more effective than the hospital-based agencies. Although they rep-
resent only 25 percent of the OPA's, they procure more than 50
percent of the kidneys.
In 1981, 4,435 cadaveric kidneys were procured for transplant
purposes. It is certain that our organ procurement system needs to
be improved because it does not in fact meet our needs. However, I
think it is very important for the committee not to lose sight of the
fact that the system actually works quite well. It is, without a
710
doubt, the most extensive and effective organ procurement system
in the world.
It also could be a very much better system. We know it could be
a better system because some parts of it are already very much
better. The best of the independent agencies retrieve twice as many
kidneys per capita as does the system as a whole. Therefore, I
think, without changing the present law and without changing our
present basic approach to organ procurement, we could double the
number of kidneys procured each year in the United States.
To bring this about, I think we need to make three basic kinds of
changes. We need to regionalize the organ procurement system. At
present, the coverage of the country is extremely uneven in terms
of organ procurement. There is one agency that covers virtually all
of New England, another agency that covers virtually all of south-
ern California, and both do very well. On the other hand, there are
four procurement agencies in North Carolina; there are four agen-
cies in Washington, D.C., here; there are five and perhaps six agen-
cies operating out of Chicago.
The result of this is that, in many cases, OPA's are simply too
small to do the job well. In some cases, they do not even have one
full-time employee. In many instances, OPA's find themselves in
competition for access to hospitals. In many of the same cases,
there is a very uneconomical replication of facilities. I think all of
these things need to be dealt with.
Therefore, I would recommend that the Government either en-
courage or enforce a regionalization program. I want to make it
clear that I am not speaking of half a dozen agencies or even a
dozen agencies. Organ procurement needs to be done on the local
level. We probably need 30 or even 40 organ procurement agencies,
but we certainly do not need 120 agencies in the Nation.
A second important change is to increase the national oversight
and accountability. The independent agencies are presently all
overseen by a single intermediary. That intermediary has full-time
employees and their task is relatively easy because those agencies
do nothing but organ procurement.
Hospital-based agencies are a very different matter. They are a
very small part of most hospitals. It is very difficult to tell exactly
what the organ procurement staff is doing. In addition, organ pro-
curement is such a very small part of what HCFA does that there
is nobody in HCFA who has responsibility to oversee these pro-
grams.
It is probably true that at the beginning of the program, this
lack of Government oversight was not a bad idea. It was a kind of
benign neglect while the program was first developing and every-
body was seeking methods of operation. But I think we are past
that stage, and we need a lot more national direction.
There are two kinds of options. One is simply to encourage
HCFA to provide that kind of oversight. I don't want to underesti-
mate the difficulty of that. There are 85 agencies, they are spread
across the country, and, most difficultly, they are embedded in very
large hospitals. So it is very hard to oversee what they do.
Another alternative solution is to encourage the development of
the independent agencies. There are three advantages, I think, to
doing that. The first is, in general, independent agencies have a
711
better track record for effectiveness. They obtain more kidneys per
population.
Second, they are increasing on their on. When I began the study
2 years, there were 21 such agencies; now there are 34. So, for a
variety of reasons, many people in organ procurement already see
the advantages of an independent agency.
And, third, they are very much easier to watch because they do
nothing but organ procurement.
However, I want to modify this recommendation a bit because
my research has not yet been completed, and until the data is in
on exactly how the hospital-based agencies work as a whole, I am
not sure I want to go quite too far. I think the spread of independ-
ent agency is a probable outcome, but it is certainly not certain.
Also, there needs to be at least a certain degree of flexibility be-
cause organ procurement needs to be done on the local level, and
therefore you need to have some flexibility as to what structures
suit local needs. But in any case, we definitely need more over-
sight, and I think that is one method of obtaining it.
The third step that is necessary if we are going to obtain a sig-
nificant increase in the number of organs is to increase the oper-
ational effectiveness of individual OPA's. The key elements in that
are that the OPA's must obtain a functional independence from
transplant teams and transplant hospitals, and they must under-
take to actively intervene in community hospitals where the poten-
tial donors are to be found.
Success at organ procurement requires the cooperation of those
who have access to potential donors. This primarily means non-
transplant hospitals and critical care personnel — nurses and neuro-
surgeons or neurologists. It secondarily means families of donors.
Therefore, OPA's are essentially marketing activities or sales ac-
tivities whose clientele are not transplant surgeons and not trans-
plant hospitals but community hospitals and those people working
in community hospitals. So that re-orientation needs to be made.
In my written testimony and in my preliminary report to HCFA,
I have detailed the kinds of managerial strategies that would lead
to this orientation, but as that required 95 pages, I will not go into
it in detail now.
I think it suffices to say here that in order to obtain those re-
sults, first of all, the agencies must be above a minimal size. A very
small agency simply does not have the manpower or the status to
be able to obtain that kind of independence.
Second, except when exceptional personalities involved, it re-
quires that the organ procurement effort be somewhat insulated
from the daily direction of physicians clinically involved in trans-
plantation.
These three changes taken together could double the number of
organs — kidneys — procured each year in the United States. It is im-
portant, however, to keep in mind the fact that the number of
organs we retrieve is not the number of organs that we transplant.
In 1981, 23 percent of the organs retrieved were not transplanted.
Some of that wastage is medically unavoidable. But the fact that
some OPA's have a wastage rate of less than 10 percent indicates
to me that a lot of it is avoidable. I don't know how to avoid it, but
712
I think that we ought to know, and someone ought to be looking
into that, because that is a terrible waste.
In passing, I would like to emphasize the fact that I don't think
that that wastage rate represents a failure of our organ sharing
system. The UNOS computer registry, which is a registry of recipi-
ents, is an absolutely basic element in the success of the Nation's
organ procurement system. By and large, it seems to me that it
works quite well.
In my written testimony, I next discuss a number of alternatives
to our present system, and I will not go into those now, although if
the committee wants to ask questions, I will be glad to talk about
that.
I would only like to emphasize two points there. First of all, I
consider that most of those recommendations are premature. Per-
haps all of them are premature. I consider that some of them are
very dangerous to organ procurement. We have a system that
works now, and I am very leery of tinkering with it without consid-
erable care.
The last point I would like to make is about the challenges facing
the organ procurement system in the immediate future. The first
challenge is one of scale. The technical advances that we have
heard so much about in organ procurement are very likely to cause
a very large increase in the demand for organs, and the system has
to be ready to deal with that.
The second challenge lies in the area of non-renal organs. It is
very important for the Committee, when trying to make policy on
the issue of non-renal organs, to keep in mind certain facts about
the present relationship between the organ procurement system
and the procurement of non-renal organs.
The first point is that there is no choice at all. The present
system is the way non-renal organs will be procured. It is a nation-
al system covering the whole country with hundreds of people
working for it, and that is the way we will procure those organs.
Second, we are already doing that. We have been procuring eyes
routinely in almost all organ procurement agencies, and in many
cases skin and bones as well have been procured on a routine basis.
Essentially, these organs have piggybacked on kidneys, and
nobody has concerned himself very much about the issue of cost.
The organ procurement system is also the way we are now procur-
ing livers and hearts, and although costs have been considered in
this area, the issue of cost has not been thought through complete-
ly. I think, we are approaching the time when it needs to be
thought through completely.
As the number of non-renal organs increases, it will be necessary
to devise a policy defining the relationship between kidney procure-
ment and the procurement of non-renal organs. It will be necessary
to decide who pays for those organs, what exactly will they pay,
and under what rules.
I think it is very important for the committee, when devising
that policy, to consider what that policy will do to the present
organ procurement system. In my judgment, right now, very few
organ procurement agencies could adequately deal with the very
complex system of multiple payers, multiple rules, and multiple
distribution systems. Any policy that does not take into account
713
the demands it places on our present organ procurement system is
likely to have some very detrimental effects.
In conclusion, I would like to say that we already have a very
successful organ procurement system and that all policy changes
that we consider ought to build on that system's strengths, and
changes in that system ought to be undertaken only with the great-
est care.
Thank you.
[The prepared statement of Dr. Prottas follows:]
714
Testimony by Jeffrey M. Prottas, Health Policy Center, Brandeis University
OBTAINING REPLACEMENTS: THE ORGANIZATIONAL
FRAMEWORK OF ORGAN PROCUREMENT*
Change begets change and technical change often begets complimentary
organizational innovation. The process is not, of course, inevitable nor is
it inevitably successful when it does occur*. Nevertheless one of the most
interesting and important public implications of tehcnical innovation is the
adaptation of implementing organizations to new demands. This phenomenon has
been observed for innovations ranging from computers^ to transit vehicles3. A
little noted but gratifyingly successful analogous process is presently
underway in the field of organ, more particularly, kidney procurement. In the
last decade our capacity, both technical and social, for replacing a
nonfunctioning human organ with another functional one has increased
significantly. For a number of reasons the human kidney has led this process
and there is now a large demand for transplantable kidneys. In response to
this need there has grown an entirely new type of organization — an "organ
procurement agency" (OPA) whose task it is to locate and obtain human organs
for transplantation. Indeed, under the dual impetus of medical capability and
government financing, there has grown an organ procurement system, complex in
organization and nation-wide in scope. This article will discuss this
procurement system, its sources, organzation, scale and the nature of its
"core technology," i.e., the organizational tasks essential to its success.
Technical and Social Basis of Organ Procurement
The need for organ procurement agencies is a function of the need for
human organs for transplantation purposes. This need, in turn, is a function
of the interaction of medical/technical advances, the prevalence of relevant
illnesses and the availability of the resources necessary to finance
transplantation. All of these have come together over the last decade.
Based in part on an article published In the Journal of Health Politics,
Policy and Law in the Summer of 1983.
715
There are a number of medical problems that must be resolved for any sort
of transplantation procedure to become clinically acceptable. Perfection of
surgical techniques and the development of immunosuppressant drugs are the
most critical and obvious. By themselves, however, they are insufficient.
The success of kidney transplantation, in terms of the numbers done,
demonstrates that some method must also be developed to permit the maintenance
of potential recipients in reasonable health while a suitable organ is being
located. Therefore, the development of the dialysis machine and the vascular
shunt have great importance in explaining the technical underpinnings of the
demand for replacement kidneys . These two medical developments, the first a
mechanism for filtering blood, the second a method of repeatedly obtaining
access to a patient's circulatory system, have permitted the development of
hemodialysis. Although there are other methods of dialyzing blood (cleansing
it of impurities) hemodialysis remains the predominate treatment for permanent
kidney failure. Patients on hemodialysis receive three 3 to 5 hour treatments
per week. These treatments involve pumping blood through a filtration system.
It is the existence of this non-surgical treatment that sets the medical stage
for the vast demand for human kidneys; the absence of a comparable treatment
for heart and liver failure has so far precluded any comparable demand for
those organs. On the other hand drug treatment of diabetes may be comparable
to dialysis in its contribution to supporting a large demand for pancreas
transplants.
Fifty-eight thousand Americans are now being treated by some form of
dialysis. This represents almost the total potential need for a replacement
for nonfunctional kidneys. (In fact there may be another 5 or 6 thousand
Americans with chronic kidney failure; the 58,000 figure only includes those
716
covered by the Social Security system. It is estimated that 10% of the U.S.
population is not so coveredS.) Not all of those on dialysis are candidates
for a transplant, most can be excluded for medical reasons. Nevertheless,
there are approximately 7,500 Americans on formal recipient registers awaiting
a kidney. Despite a slow increase in the number of transplants done each
year, this list has shown no sign of diminution. As about 3,400 cadaveric
transplants were done in 1982, there is clearly a great excess of demand for,
over supply of, replacement kidneys.
Indeed preliminary work done at the University of Toronto implies that
there may be a substantial reserve demand not listed in registries*. Some
have estimated this demand is in excess of 22,000?. The AMA' s Council on
Scientific Affairs sets it ev*n higher. They believe that half of those on
long-term dialysis may be potential candidates for a transplant. In their
view the desirability of that option will, in the next few years, be enhanced
by advances in the "control of the rejection mechanism. "8 Indeed one such
advance, an immunosuppressant drug called cyclosporin will probably enter
regular clinical use this summer. Many of the transplant surgeons I have
interviewed believe this drug will have a substantill effect on kidney graft
survival and an even more significant effect on graft survival rates for non-
renal organs. We must therefore anticipate a large increase in the demand for
transplantable organs, both renal and non-renal, in the near future.
In some sense the underlying human demand for a transplantable kidney (or
any other organ) is independent of technical/medical factors. It reflects the
frequency of kidney failure and the medical characteristics of its sufferers-
which defines how many victims are candidates for transplant surgery. In
practice the actual demand for transplantable kidneys represents some
interaction between technical and human factors. The inadequacy of early
717
estimates of the potential demand for dialysis and the continuous growth of
the dialysis population both illustrate this interaction effect.
In 1963, the Artificial Kidney Center in Seattle, the center of pioneer
work in dialysis, estimated that there were 5 to 20 "ideal" candidates per
million for dialysis in the State of Washington9. In 1967, the Gottschalk
report estimated that there were only 4,000-5,000 new potential dialysis
patients each year in the United States10! Even as late as 1972, median
estimates of 7,500 suitable patients was considered sound11; yet, in 1981,
21,535 patients started dialysis for the first time11. Since kidney failure
is 100% fatal if untreated these estimates provide a striking example of the
interaction between the demand for and the availability of a medical service.
This should be kept in mind when considering the probable demand for other
organ transplants.
But, as Braudel points out "...No innovation has any value except in
relation to the social pressure that maintains and imposes it. J In this
case neither the prevalence of kidney failure, nor the availability of
techniques to treat it, generated a serious demand for transplantable kidneys
until the U.S. Congress was prevailed upon to bear the cost of all forms of
treatment for permanent kidney failure. Congress' reason for doing so are
complex and need not concern us14, but the step itself was critical because
dialysis and kidney transplants are both extremely expensive and beyond the
means of almost all Americans. In 1972, the Congress passed the End-Stage
Renal Disease Program (PL 92-603) by which it undertook to cover, under the
Social Security system, all victims of permanent kidney failure. In 1967,
there were 1,000 patients on dialysis in the United States. In 1973, there
were 11,000 patients and last year (1982) an estimated 58.50015.
23-029 0-83-46
718
While the growth in the number of transplants has been much slower, they
too are clearly the result of this social decision to publicly support the
cost of treatment for kidney failure. Indeed it has been from the first the
official policy of the government to favor transplantation as a treatment
modality.
All these factors, technical, human and social, have worked together to
generate a need for human kidneys and this, in turn has brought into existence
organizations dedicated to fulfilling that need. (These organizations too are
supported by public funds under the End-Stage Renal Disease (ESRD) program.))
In 1982 approximately 4,400 cadaveric kidneys were obtained in the United
States. Of these perhaps 3,400 were in fact transplanted, representing 70% of
the organs transplanted that 'year. (The remainder were obtained from a living
relative of the recipient.) This represents only a small percentage of the
total number of organs theoretically available. Obviously estimating the
number of deaths that might have resulted in producing organs suitable for
transplantation is very difficult and such a figure must be treated with
reserve. Nevertheless it has been estimated that some 50,000 transplantable
kidneys become potentially available each year.15 Even if more conservative
estimates are used it is clear that the number of potentially usable kidneys
does not represent a limitation of the ability of organ procurement agencies
to meet the demand. On the contrary, the limiting factor in kidney supply
lies in the organizational ability to locate and obtain organs.
The Organ Procurement Process
From an organizational point of view organ procurement is a complex and
difficult task. Success requires the cooperation of many actors not in the
719
procurement agency itself — neuro-surgeons, nurses, families, other procurement
agencies, tissue typing laboratories and transplant surgeons. Each and any of
these people can, by acts of commission or omission, cause the procurement to
fail. It is the Procurement Agency's task to motivate all of them to cooperate
and to structure the situation so that they can do so in ways consistent with
their primary responsibilities. In addition the Agency must coordinate the
activities of each and complete other tasks assigned to it.
The actual sequence of organ procurement differs from agency to agency
and, indeed, from donor to donor, however, the basic elements are always the
same. The first step is a telephone referral. Usually an Intensive Care Unit
(ICU) nurse calls to say that they have a potential donor. (Most donors die in
such units; for medical and organizational reasons very few die in emergency
rooms.) The suitability of the donor is determined in a preliminary fashion
either over the phone or later at the hospital. Donor maintenance steps may
be necessary — maintaining fluid balance for example. At this point the
patient is still alive so, of course, no steps inconsistent with treatment are
taken. However, contact is not undertaken until it is clear that the patient
is dying. In some cases a representative of the Agency will go into the ICU
to be on hand when the patient dies. This varies by policy, timing and
geography. Once a patient has died a neuro-surgeon must be obtained to
declare brain death and the family must be notified. Most Agencies prefer the
physician or the nurse to have prepared the family for the possibility of
donation earlier, during the time they were preparing the family for the
imminent death of their relative.
Once the patient has been declared brain dead the family must be
approached for permission to remove the kidneys. Although every state has
720
passed the Uniform Anatomical Gift Act which permits a "will" authorizing
organ removal, hospitals will generally not remove organs without family
permission. Once approval is obtained steps are taken to maintain the
viability of the donor's kidneys and blood may be taken for preliminary
typing. The Agency must then arrange for an operating room and a removal
team. The kidneys must be removed under sterile conditions and by a
physician. In many cases an Agency will also try to obtain permission to
remove other organs. Most do this almost routinely for eyes and on special
request for bone, skin, heart or liver. If permission is obtained the
relevant agency is contacted to come and remove "their" organ.
Once the kidney is removed the agency has complete responsibility for it.
It must be evaluated and preserved. Preservation is done by one of two
methods. Either the kidney is packed in ice, or it is placed in a special
"perfusion machine" designed exclusively for kidney preservation.
Tissue samples are sent to a histocompatability laboratory. Tissue
typing may take from A to 10 hours. Once the immunological characteristics of
the donated kidney are known the search for a suitable recipient can begin.
All OPAs first search the list of transplantation centers in their catchment
area. Decision criteria for what constitutes an acceptable match vary and are
in the hands of a medical board or the transplant surgeon.
If no local recipient is suitable the Agency attempts to export the
kidney. All those east of the Rocky Mountains employ the UNOS (United Network
for Organ Sharing) list of transplant recipients to locate a potential
recipient. Each Agency uses somewhat different techniques for choosing which
organ procurement agency to call about a kidney. The first test is generally
the apparent quality of histocompatability match between the kidney and the
recipient. However, other factors often come in. Location is one — close
721
transplant centers are preferred as transportation cost and time is minimized.
But the existence of alternative potential recipients is also a factor. It is
not possible to be sure that any given recipient will actually test negative
with any specific kidney, therefore, sending a kidney is always a risk. If
the first patient's blood reacts to the offered kidney it is necessary to find
a substitute, for this reason, a transplant center with alternative possible
recipients is preferred. The procuring agency has the responsibility of
physically transporting the kidney. Once the kidney is placed with a local
transplant surgeon or sent to another center, the job of the procurement
agency is over. Naturally, an OPA will be on the other end of the organ
sharing process in which case once the kidney has been accepted by them and is
delivered it is tested against potential recipients locally. If no match is
found the OPA will then usually try to re-export the kidney. Those in organ
procurement have a very strong commitment to using every kidney available.
All this must be done at unpredictable intervals and within a very short
period of time. The location of a potential donor and the timing of his
availability are unpredictable. In some cases weeks, even months, can go by
without a single donor; at other times two, three or four donors may be
available simultaneously. The process of donation must be completed quickly.
Potential donors are typically not in the hospital long before death and while
a brain-dead donor can be maintained for some time before it becomes essential
to remove the kidneys, it is medically risky to delay and socially difficult.
Once a family has consented to donation they are understandably anxious to
have the process finished immediately.
Even after excision there is time pressure. A kidney out of the body
over 24 hours becomes increasingly difficult to place with a transplant team.
722
A survey of 35 transplant centers indicates that 25 of them will not use a
kidney that was removed more than 50 hours before (30 hours if a less costly
preservation system is used) . This 30 or 50 hours must include transportation
and tissue typing time. Time pressures are present throughout the procurement
process.
Of course, the original steps needed to procure kidneys start before the
death of any potential donor. A procurement agency must first decide which
hospitals ought to be asked to refer appropriate patients to the program.
This is a strategic decision of the first importance. Not all hospitals are
equally useful in this role. At a minimum a referral hospital must have an
emergency service (85% of donors die as a result of accidents) and a
neurosurgeon (or a neurologist) to declare brain death. (In practice only a
patient whose heart is still beating is of use as a donor, this obviously
requires that he or she be declared dead using brain death criteria.) Beyond
these requirements a number of delicate balances must be struck. Each agency
only has limited resources and experience has shown that most hospitals have
to be in frequent contact with the Agency if they are to routinely refer
donors. A smaller number of hospitals makes effective contact possible; a
larger number increases the coverage of the potential donor pool. The kind of
hospital is also an issue, large city hospitals see the most trauma but are
not always the most cooperative, smaller outlying hospitals have fewer
potential donors and are harder to cover (because they are geographically
dispersed) but are often willing to be involved. Finally, the issue of how
much contact is appropriate must be resolved. Excessive contact is both
wasteful and may antagonize critical personnel; too little contact and the
staff tends to forget to be watchful for opportunities.
723
Once a hospital has agreed to participate, the cooperation of critical
staff must be obtained. These are the neuro- surgeons, or less commonly, the
neurologists, and the intensive care nursing staff.
The cooperation of the neuro-surgeon is necessary as almost all potential
donors are his patients. He therefore has formal responsibility for them and
must give permission for the organ procurement agency to be contacted
regarding them. In addition, he must declare the patient brain dead and so
inform the family before any donation related activities can take place.
■ The intensive care, often the neuro-intensive care, nursing staff are
also critical. Most of the in-hospital burden of organ procurement falls on
them. They usually must actually contact the agency. They care for the dying
patient and must monitor his condition and perhaps take steps to protect his
kidneys. They often have the most dealings with the donor's family. Indeed
it is generally they who take the active role with the physician merely
acquiescing .
One of the primary responsibilities of a procurement agency is to
motivate these people. Unless the nursing staff and the physician cooperate
the agency will not even be informed that a potential donor exists. This
responsibility is discharged via some form of "professional education." This
ill-named activity absorbs a substantial part of the time of OPAs . It may
take any of a number of forms, from periodic visits to intensive care units
(ICUs) simply to maintain contact with nurses, to yearly meetings with all the
trappings of professional association gatherings. A major issue in organ
procurement is how "professional education" ought to be done. In any case
this, unlike hospital selection and contact, is not a single act but a major
ongoing responsibility. Motivation must be continually reinforced.
724
A separate activity undertaken by many OPAs is public, education.
Strictly speaking this is not part of the organ procurement process but is
meant to facilitate that process by increasing public awareness of and support
for organ donation. The ultimate goal of public education in this area is to
increase the probability that a potential donor's family will grant permission
to excise the kidneys. Procurement agencies vary greatly in their commitment
to public education and there is controversy over its effectiveness and
appropriateness1 .
The Organ Procurement System
As difficult as these organizational tasks may be, there is a large
network of organizations involved in completing them. Nation-wide there are
approximately 152 transplantation hospitals in th United States18; with few
exceptions each of these is involved through some organizational arrangement
in kidney procurement. About 85% of these hospitals run their own organ
procurement agency, the remainder depend on one of the 32 active "Independent
Organ Procurement Agencies." (There are 2 other such Agencies that don't
actually procure kidneys). All organ procurement agencies (OPAs) have certain
things in common. All are non-profit agencies, either directly incorporated
as such or operating as a division of a hospital. All are funded by the
same End-Stage Renal Disease Program that pays for dialysis treatments.
However, unlike all other aspects of the ESRD Program the government pays 100%
of "kidney aquisition costs", as opposed to 80% of costs covered for all other
medical expenses. In this sense OPAs are "fiscal drops"1', i.e. they are
solely dependent on the government for financing and they operate solely to
further a specific governmental goal but they are not governmental agencies in
725
a legal sense. They are a public-private hybrid that would be termed
"strange" were they not so common.
The Independent Organ Procurement Agencies (IOPAs) differ in a number of
ways from hospital based Agencies and are important out of proportion to their
number. The formal distinction lies in the fact that they are not part of any
direct medical delivery organization but are separately incorporated
non-profit organizations. But more important than the formal organizational
differences are the differences in size and effectiveness. On average the
IOPAs are larger, more effective and more innovative than are the hospital-
based Agencies — although, of course, exceptions to this generalization can be
found among the over 80 hospital-based Agencies.
Many of the IOPAs are regional in scope. For example one IOPA draws
organs from all of New England, two share almost all of Texas between them,
two others share Pennsylvania, and overlap into New Jersey, Ohio and West
Virginia. Although IOPAs represent only some 18% of the nation's procurement
agencies, they actually obtain over 40% of the nation's transplantable
kidneys. This disproportionate success reflects more than simply larger
catchment areas; IOPAs are, on average, more effective than hospital-based
agencies.
The Atlanta based Center for Disease Control has undertaken a number of
retrospective record reviews in hospitals to estimate the number of potential
kidney donors as a percentage of all in-hospital deaths"'0. While the
resultant figures are merely estimates and can be expected to vary over time
and across locations they do provide a yard-stick against which to measure
organ procurement agency success. If the entire nation were serviced by
726
procurement agencies as effective as the IOPAs, a 50% increase in the number
of kidneys procured could be expected. If it were covered by OPAs as
effective as the most effective IOPAs, the number of organs retrieved would be
doubled21!
Perhaps this effectiveness is part of the reason for the rapid growth in
the numbers of IOPAs in the last year. At the end of 1980 there were 21
organizations designated as IOPAs, by the summer of 1982 there were 34. The
importance of the IOPAs to the organ procurement system is not only large but
growing. This is not to say that one finds a high degree of uniformity among
IOPAs either in scale or effectiveness. Their explosive growth alone would
preclude this. Some have yet to obtain their first kidney, and some have
retrieved many hundreds over the years. Some directly serve more than half a
dozen transplant hospitals, some only one. The largest had a budget of 1.5
million dollars in 1980, the smallest (in the program at that time) has a
budget of only $33,280! There is also a great deal of organizational
variation to be found; some IOPAs grew out of local Kidney Foundations and
retain those ties, others eschew any relationship with the Kidney Foundation;
some are under the direction of the entrepreneurial physicians who founded
them, in others the medical presence is all but invisiable in daily
operations. Add to this the regional, operational and even philosophical
differences and the IOPAs are a heterogeneous group. In the next section we
will condiser what shared characteristics can explain their apparent successes
in organ procurement.
Variations among the hospital-based agencies is, of course, even greater.
Some are procurement agencies only in name, having no full-time staff and
procuring few if any organs, others operate full-fledged procurement agencies
727
with national reputations. Unfortunately detailed data on the variations
among hospital based procurement agencies is not presently available. The
author is presently engaged in gathering such data.
Despite the differences between and within the two types of organ
procurement agencies the nation does have a reasonably integrated organ
procurement effort. This is demonstrated by the dependence of organ
procurement agencies on the inter- agency exchange of kidneys. Again good data
is available only for the IOPAs, but it shows that approximately 37% of the
kidneys procured by IOPAs are exported by those Agencies to some
transplantation hospital outside of their catchment area. A marginally
smaller number are imported into by IOPAs from other centers. This means that
almost 40% of all kidneys transplanted in hospitals associated with IOPAs do
not originate in the region where the transplant takes place. As individual
IOPAs are, on average, more than twice the size of hospital-based agencies
this percentage is presumably far greater among hospitals with their own
procurement effort. (Among transplant hospitals in Washington, D.C., 60-80%
of the transplanted kidneys were obtained by an OPA other than the hospital's
own.)
This extensive inter-agency flow of organs is possible only because the
United Network for Organ Sharing (UNOS) provides a continually up-dated
computer print-out of all patients awaiting a transplant at any transplant
center east of the Rocky Mountains and most of those on the West Coast as
well. The UNOS listing displays potential recipients categorized by
histocompatability characteristics and so permits a simple search for
potential recipients.
728
The search is almost nation-wide because not all of the West Coast
agencies list with the UNOS system. In addition, there are certain regional
and "network" biases in inter- agency organ sharing. The regional effects are
largely the result of time constraints — kidneys cannot be maintained outside
of a human body very long and so there are strong reasons to ship them to an
accessible location. This also gives Agencies located at major air centers an
advantage and has caused some of the less accessible Agencies to purchase
airplanes. The "network" effect reflects the uncertainties of
histocompatiability matching and organ removal and preservation. Sharing an
organ involves both parties in an act of trust — the receiver must trust the
competence of the providing agency and the provider must trust the receiver to
find a suitable recipient if the best one listed on the computer doesn't prove
suitable. Larger agencies and those that import and export frequently develop
the contacts and trust and will therefore be preferred partners. Beyond these
caveats, however, the inter-dependency of procurement agencies is substantial
and makes it sensible to see them as part of a single national system rather
than as 120 purely local efforts.
Marketing and the Success of the IOPAs
The greater success of Independent Organ Procurement Agencies can, in
large part, be attributed to their greater willingness and capacity to see
their "clientele" as the staffs of non- transplant hospitals, and to
aggressively market organ procurement to that clientele. Historically, this
is not the orientation of organ procurement.
In most locations organ procurement efforts began as ad hoc activities of
involved physicians. These physicians employed their personal medical
729
contacts in their own and nearby hospitals to obtain assistance and referrals.
The basic motif of these activities was personal assistance to help supply the
raw material for the physician's work, or, more generously, to aid the
physician in the care of his patients. In most instances, formal organ
procurement agencies evolved when the physicians found the burden of work too
onerous and the yield of organs too small.
Organizationally, hospital-based procurement agencies remain extensions
of the transplant surgeon's or nephrologists' reach — they are structurally
ancillary to the transplantation team. Nor have all IOPAs outgrown this
orientation, in some the medical director's daily involvement enforces,
informally, the dominance of the direct medical service delivery orientation.
Nevertheless IOPAs as a group have moved, to varying degrees, away from this
definition of their role and therein lies the ground of their success.
The final goal of organ procurement is, of course, to provide a
transplantation team with the organs they need; but the basic task of an organ
procurement agency is to mobilize and maintain support for organ procurement
from those individuals and institutions that control suitable cadavers.
Within the transplantation hospital it may be possible (but often is not) to
use the power of the transplantation service to obtain cooperation from the
critical care units that control potential donors. Outside of the
transplantation hospital cooperation can only be obtained by manipulation.
The sine qua non of successful organ procurement is salesmanship.
There are three gorups that control an organ procurement agency's access
to human organs, two are medical professionals in non-transplant hospitals,
neuro-surgeons and intensive care nurses, and the third is the family of the
potential donor. These represent the critical environment of the Agency, not
730
transplant surgeons and these must be "sold" on organ donation If the Agency
is to be effective. IOPAs, organizationally and operationally more distant
from transplantation hospitals, have generally been more successful in
recognizing and adapting to this reality. The growth of the inter-agency flow
of kidneys has, of course, been a pre-condition for this change as a
procurement agency no longer depends on a single team to take all its kidneys.
Both psychologically and, to a lesser degree, practically, procurement
Agencies no long "work for" a single team but serve the entire transplantation
community.
The conceptualization of organ procurement as a medical marketing
activity rather than a medical service activity has implications for the sorts
of people hired by the Agencies, the role of medical training and expertise in
the Agency and the strategies pursued by the Agency's management. In all of
these areas IOPAs have made progress.
The "keys to the kingdom" are held, in organ procurement, by the nurses
and neuro- surgeons (sometimes neurologists) in non-transplant hospitals. It
is they who control access to donors by informing the Agency of suitable
patients. Their assistance is entirely voluntary — it cannot, ethically or
legally, be compensated in any significant manner. (Strictly, no one involved
in transplantation can declare a patient brain dead; practically, it is
undesirable for anyone responsible for the care of a potential donor to derive
any personal benefit from the donation of his or her organs.) Organ
procurement agencies are selling altruism.
Involvement in organ procurement is not costless to medical personnel, it
has both time and psychological costs. The neuro-surgeon has to declare a
patient brain dead — a more involved and touchier step than simply letting a
731
heart stop. He must explicitly confront his failure to save a patient,
indeed, often anticipate it, and he must deal with the grief of the patient's
family while explaining brain death to them. The nurse's responsibilities
also increase. She bears an even greater burden for dealing with and talking
to the family. She too must anticipate the death of a patient and often treat
the "patient" after death, or while awaiting its official declaration, in
order to protect his or her kidneys. This is a difficult psychological shift
from the single-minded dedication to saving life typical of intensive care
units. Indeed, in practice, it is on the nurse that the primary
responsibility falls for identifying potential donors and initiating the
entire process.
To induce this kind of cooperation organ procurement agencies depend
primarily on "transplantation" or "procurement" coordinators. Medical
expertise is relevant to the success of these coordinators almost solely as it
acts to legitimate them with the hospital staff. It is the universal
observation of coordinators that the medical expertise demanded of their jobs
can be learned quickly by any intelligent person. (The removal and
preservation of the kidney is another matter and is, often, not part of the
coordinator's job. Indeed the trend toward dividing these aspects of organ
procurement is symptomatic of its journey from medical to marketing
orientations.) Among IOPAs, from 30% to 100% of the coordinator's time is
spent in some form of marketing to these critical people. (Excluding time
spent preserving organs in those Agencies that continue to combine these
functions.) These marketing efforts are primarily of three types: personal
selling, known as "surveillance," group presentations, known as "professional
732
education," and the organization of conferences and testimonials. All three
are variants of classical marketing techniques.
There are controversies among IOPAs over the effectiveness and even
appropriateness of some of these marketing techniques; however, a majority of
IOPAs routinely use all three. Personal selling is used or approved of by 70%
of IOPAs, it is the most controversial approach. Concretely, it consists of
unscheduled periodic visits to critical care units of associated hospitals
primarily aimed at maintaining an awareness of organ procurement among ICU
nurses. Its efficacy depends on the development of a good personal
relationship between the coordinator and the hospital's ICU nurses. The
approach is, therefore, low key and supportive; quite consistent with modern
"customer-problem" approaches 2 to salesmenship.
"Professional education" approaches are more formalized. They usually
consist of "in-service" training classes for nurses. Their formal goals are
indeed educational and they certainly contain information of a technical and
organizational nature about organ procurement and transplantation. Like
"surveillance", however, their implicit goal is exhoratory. Unlike
surveillance they depend less on developing a personal relationship and more
on the use of professional and heirarchical authority to validate the
professional involvement of nurses in the program. The fact that these
sessions are formally sanctioned by the hospital and are presented in a
classroom format support the marketing message.
Organizing conferences and meetings is a widespread, although minor,
aspect of most IOPA's marketing efforts. The professional content of the
sessions reinforces the message that organ procurement is a professionally
appropriate activity in which to be involved. The fact that the meetings are
733
held in pleasant surroundings and that the costs are often subsidized by the
Agency also promotes good will and a sense of solidarity among participants
and the Agency. The soundness of this approach is attested to by widespread
corporate practice.
Inducing the family of the potential donor to grant permission to remove
the kidneys is the last step in the procurement process. It is also a most
delicate process requiring, from the "salesperson," both sensitivity and
dedication. Humanity and efficacy require that the bereaved family be
approached with consideration and empathy. All coordinators interviewed were
very concerned not to increase the grief of the potential donor's family. At
the same time, no routinized "pitch" could convince a family to give
permission. Success requires careful attention to the concerns of the
particular family being approached — reasons for permitting donation are
multi-faceted and complex and must be addressed. This is the most difficult
kind of "selling." Independent Agencies are remarkably successful at this.
Coordinators report permission rates of 60-80% among white families. Success
among blacks is much lower^-5.
Finally, IOPAs have a great advantage in flexibility over most
hospital-based Agencies. A hospital-based Agency that wishes to take a
marketing approach may find itself unable to choose its targets effectively.
Depending on its particular circumstances it may find itself limited to
working at a few pre-selected hospitals. If these are not fertile ground,
because of patient make-up, attitudes of key personnel, etc., there is little
that they can do. An IOPA, on the other hand, can pick and choose among
hospitals in order to find the most responsive to its marketing efforts. Of
course, in the highly politized atmosphere of many medical communities, the
?^-n2q n - 83 - 47
734
IOPA's choices may not be completely unfettered but it would still have the
advantage over a hospital-based program. Indeed, in some locations, the
IOPA was founded because the rivalry among hospitals could only be contained
by the introduction of a neutral outside party.
Conclusions and Recommendations
Like blood, human kidneys can neither be manufactured nor adequately
substituted for. Like blood, the potential supply of kidneys is practically
limitless. Like blood, the actual supply of kidneys is largely a function of
the effectiveness of the organizational infrastructure designed to obtain it.
Unlike blood, the demand for kidneys is limited, however, it is large and
growing. It presently exceeds supply substantially and there is reason to
believe that recent developments in innumospression drugs will further
increase that disparity. The looming non-medical issue in the transplantation
field is, therefore, whether the organ procurement system has the capacity to
respond to Increased calls for organs.
This is a question for public policy because the End-Stage Renal Disease
Program has made the federal government the sole purchaser of human kidneys.
It has financial implications for the ESRD program as transplants can be less
expensive than dialysis. It has human implications because a successful
transplant is both medically and socially superior to dialysis. Quality of
life is far better.
The experience of the Independent Organ Procurement Agencies demonstrates
that is is possible to greatly increase the number of kidneys retrieved in the
United States under present laws. What is needed is an acceptance of organ
procurement as an exercise in public service marketing aimed, primarily, at
735
medical professionals who can refer potential donors and, secondarily, at the
families of those donors. This requires both the psychological and
operational liberation of organ procurement from direct medical service units.
Independent Agencies have demonstrated that one way to obtain this is through
structural separation of the procurement agency and the transplant hospital.
It is too early to state categorically that structural separation is a
necessary condition for the development of a marketing orientation in organ
procurement. It is certainly not sufficient as some IOPAs are organizationally
distinct from transplant hospitals but operationally tied to a medical service
orientation. Organizational data on the hospital based programs is only now
being gathered and their lesser average effectiveness may hide some alternative
models for obtaining the necessary operational flexibility. The critical
factors for success in organ procurement are the desire and capacity to orient
the organization toward the suppliers of kidneys not the users; organizational
independence is a means to that end not an end in itself. Whether there are
other practical means remains to be determined.
One thing is already clear, it is possible to increase the available
cadaveric kidneys by orgnizational means. This has two important implications.
The first is obvious, this ought to be done and it is, at least in part, the
Federal government's responsibility to do it. The second is perhaps less
obvious. Altruism works. That it can be encouraged and fostered by sensible
"marketing" in no way undermines this fact. The marketing efforts that have
such a good effect on organ procurement merely increase the salience of the
altruistic impulse in those involved and diminish the obstacles to its
exercise^.
736
There are reasons to value the centrality of altruism In organ donation.
Titmus has presented the social and moral advantages of altruism in the context
of blood donations. He argues that the right to act altruisticly is an
important human right and that its exercise is morally and psychologically
beneficial. He further argues that society benefits from the enhanced sense of
communicy that flows from "gift relationships^."
It is not necessary to accept Titmus' s agruement to see that efforts to
increase our supply of transplantable organs ought to begin with improving the
extensive organ procurement system we have already developed. If incremental
improvements in our present approach can meet our needs, then more sweeping,
and risky, changes can be avoided.
Substantial increases in our supply of cadaveric organs can be obtained by
improving the effectiveness of the nation organ procurement systems without
recourse to basic changes in the law or ending our reliance on altruism.
Variations within the present system indicate that, if the entire nation were
serviced by organ procurement agencies as effective as the most effective
Independent Organ Procurement Agencies, it might be possible to almost double
the supply of organs. Such an increase would require the Health Care Financing
Administration to take steps to improve the system overall and would require a
number of operational changes to occur in the organ procurement agencies
themselves.
System-wide Reforms
Regionalization of Organ Procurement
The present organ procurement system has grown in response to local
medical practices, preferences and politics. As a result, the distribution of
737
OPAs across the country is absurdly uneven: a single agency services almost all
of New England, another almost all of Southern California; yet Washington, D.C.
has four agencies, Chicago has six and Louisiana, four! It may be that some
OPAs have grown too large to effectively service their catchment areas, but it
is certain that many OPAs are too small to do so. Some hospital based programs
do not, in practice, have a single full-time organ procurement coordinator;
many have only one. For a task that requires twenty-four-hour- a-day
availability, quick response to referrals and unrelenting efforts to insure
the participation of hospitals, nurses and doctors, there are clearly critical
economies of scale. Moreover when several agencies attempt to operate in the
same area, no amount of cooperation (and in multi-agency areas cooperation is
not always a reality) can avoid inefficiencies. There is often a duplication
of preservation and laboratory facilities and each agency faces artificial
constraints on its choices of community hospitals in which to work. (The
duplication of certain kinds of facilities occurs even in some Independent
Agencies because hospitals are unwilling to surrender control over certain
kinds of tissue-matching and preservation labs. This also is a poor use of
public money.) The Health Care Financing Administration ought to address
itself to this problem and encourage, or enforce, a more uniform coverage of
the nation via some regionalization program.
Oversight, Direction and Support
Organ procurement is only a small part of HCFA's total budget. This,
combined with a recent organization that eliminated the Office of End-Stage
Renal Disease, means that there is no one in the Administration with over-all
responsibility for organ procurement. This has meant a virtually untrammeled
738
independence for hospital- based agencies as well as a total lack of direction
and support. (Independent Agencies are administered separately.) The smaller
agencies especially could benefit from assistance from Washington in matters of
law and effective procedure. The absence of oversight raises other kinds of
problems. It appears probable (but the data is still very sketchy) that many
hospital based programs fund activities under "kidney acquisition" that may not
strictly belong under that rubric. Unlike all other reimbursements, organ
procurement is reimbursed at 100% of cost. Hospitals are very complex
organizations and activities closely related to organ procurement and
transplantation such as research, immunology laboratories, transplant recipient
work, etc., can easily shade into "kidney acquisition." This can be done
without the least intent to act inappropriately but, without guidance and
systematic oversight, it is inevitable that the ESRD program pay for activities
that are not really organ procurement.
One possible solution to this is closer oversight of hospital based
programs, another is to encourage the phasing out of hospital based programs in
favor of Independent Agencies. The oversight issue alone would not justify
such a step but, combined with the apparent superior effectiveness of
Independent Agencies, such a policy might be considered. Because the research
into hospital-based agencies is not completed, it is premature to urge such a
solution. However, it ought to be added that the rapid growth in the number of
Independent Agencies over the last year implies that the organ procurement
community itself sees certain persuasive advantages to that form of
organization.
739
Operational Reforms Within Organ Procurement Agencies
Motivating Medical Professionals
Obtaining the assistance of nurses and physicians in community hospitals
is the most important element in successful organ procurement. For this
reason, knowledge of variations in local attitudes and practices are of great
importance and no single, rigid formula for success can be insisted upon.
Nevertheless, certain kinds of activities have been shown to be effective in a
variety of settings.
• The utility of in-service training sessions as a motivational tool is more
or less universally acknowledged and so doesn't need to be stressed. The
effectiveness of "surveillance" is less widely accepted but is also great.
The Center for Disease Control has pioneered the use of surveillance in
organ procurement. In their terminology, surveillance is "the continual
process of identifying and reporting each potential donor soon enough to make
retrieval possible."26 While the CDC type of surveillance has proven
effective, it is also very time-consuming and expensive. A more operationally
applicable form of surveillance emphasizes the marketing goals of the organ
procurement agencies and so is directed more toward maintaining the involvement
of nurses than toward directly identifying potential donors. The type of
surveillance I advocate involves regular but unscheduled visits to critical
care units by organ procurement coordinators. The purpose of these visits is
not to find a donor but to increase the saliency of organ procurement among the
nursing (and perhaps physician) staff and to develop a personal relationship
with the staff. The development of this kind of relationship is a critical
component of many kinds of salesmenship and can be very effecacious. However,
it does not require the intensity of involvement implied by the CDC approach
740
and so permits a single coordinator to service a far greater number of
hospitals.
Strategic Planning and Hospital Selection
Which hospital to concentrate on is a critical decision for an organ
procurement agency. Most agencies think far too little about this decision,
and, as a result, many disperse their efforts too broadly. The desire to work
in as many hospitals as possible is an understandable one; it is the desire to
obtain access to as many potential donors as possible. However, some agencies
claim to work in 150 hospitals and will actually obtain organs from as many as
40 in the course of several years. Yet my own work and that of the CDC
indicate that only a small percentage of hospitals provide the bulk of the
donors; most OPAs spread themselves too thin.
The CDC methodology involves extensive reviews of medical records in part
to determine which hospitals ought to be worked with. This is certainly the
most accurate approach and necessary in a research/demonstration project, but
it is far too costly to be used routinely. In their excellent Georgia
demonstration, one third of the staff were involved solely in record reviews.
Employing cruder rules of thumb and using that third person to increase ones
organ procurement capacity are probably better approaches for most OPAs.
In practice the selection of appropriate hospitals must consider local
medical politics and the receptivity of critical staff within a given hospital.
Beyond that certain "first cuts" can be done. In almost every OPA so far
studied, suburban hospitals and regional trauma centers were the best source of
kidneys. Rural hospitals are often too small and without a staff neurosurgeon
or neurologist to declare brain death. Indeed they often transfer potential
741
donors to hospitals better suited to deal with their injuries. In addition,
for reasons not completely clear, many inner-city public hospitals are very
poor sources of referrals.
The most productive hospitals in which to invest staff time are probably
those that have provided a moderate number of referrals in the past. Units
that refer one patient a year probably cannot be effectively worked with. In
part this is because their patient mix may be inappropriate but it also
reflects the difficulty of motivating a staff that gets the satisfaction of
actually producing a donor so rarely. On the other hand, the most active
hospitals do not need to have surveillance. They obtain sufficient feedback
from actual donations to sustain their involvement, and the coordinator's
personal relationship is maintained in the best way - by working with nurses to
retrieve organs. The best return on investment therefore probably lies in
hospitals between these extremes. It is desirable for an OPA to limit the
number of hospitals to fit its resources rather than to spread its resources to
match all those hospitals willing to be involved.
The Wastage of Kidneys
The steps recommended up to now could increase the number of kidneys
procured by as much as 100%. However, the number of organs procured is not the
same as the number of organs actually transplanted. In 1981 23% of all kidneys
obtained from cadavers were not transplanted, they were wasted. Eighteen
percent of those procured by independent agencies were wasted.) Reduction of
this "wastage rate" could contribute to the nation's supply of organs in an
important way. As in so many areas there is great variation among OPAs in
terms of their wastage rates. Limiting ourselves to Independent Agencies, we
find rates that vary from 6% to over 40%. The causes of these variations are
742
not known and research into them would certainly repay the government in terms
of additional usable organs, and as any decrease in wastage decreases the
average cost of a kidney, it would probably repay the government directly as
well.
The probable causes of organ wastage are four; anatomical or biological
shortcoming in an excised organ, surgical errors in excision, administrative
shortcomings that cause the organ not to be placed with a recipient and non-
existence of a suitable recipient. Cause one and four are uncontrollable but
their overall contribution to wastage is not known. In addition, it ought not
be assumed that the lowest rate is the best; a very low wastage rate may
reflect an excessively conservative procurement policy that fails to obtain
many suitable organs. All of, these questions are easily researchable and HCFA
ought to direct its attention toward them.
Modifying the Voluntary System
In the last few years, as recognition of the kidney shortage has spread,
there has been a number of proposals for altering our present organ procurement
approach. In general, and to varying degrees, these proposals involve the
introduction of incentives or coercion into the system as a way of increasing
the rate of donation. In my judgement, these proposals are premature and, in
some instances, reckless.
It is possible that the reforms I have discussed will provide a supply of
organs sufficient to our needs in the future, in which case there is no reason
to abandon a successful approach. However, it must be admitted, that it is
also possible that the demand for organs, renal and non-renal, will outpace the
supply that our present purely voluntary system can provide. We are apparently
on the verge of important changes in the transplantation field, new organs are
743
/
being transplanted and new drugs are being developed. These changes could
sharply increase the demand for transplants as both the range of potential
recipients increases and as higher success rates make the transplantation
option relatively more attractive. We ought to prepare for this eventuality
now.
What follows is a brief evaluation of the more prominent modifications of
our present voluntary system. Some of these evaluations are tinged with
trepidation, some with explicit skepticism. At our present state of knowledge,
the best and most hopeful of them ought not to be tried; right now, we simply
know too little of the effect of introducing incentives or coercion into the
procurement process. In the view of many in the organ procurement business,
the entire process is fragile and could be dangerously disrupted by ill-
thought-out changes. I therefore urge, in the strongest terms, that a slow and
scientific inquiry be made into the probable effect of any proposal before it
be instituted. If such a process can be started before the pressing exigencies
of an increased organ shortage are felt (if they will be felt at all), we can
proceed in the future with far greater certainty and far less risk.
Plans for altering the Consent Process
Two plans have to be discussed for altering the present process of
consenting to become an organ donor: one would require everyone under 65 with
a driver's license to respond "yes" or "no" to the question of whether they are
willing to become a donor; the other alternative is to institute an "assumed
27
consent" law like those now existing in certain European countries .
I am very skeptical of both alternatives. The more modest of them,
requiring a declaration, is, in my judgement, neither enforceable nor
desirable. I am not sure that is is legally permissible to require drivers to
744
make such a declaration; I am reasonably sure that It Is practically
impossible to enforce such a law if passed. Even if passed, it would not serve
to increase the number of donations.
Under the Uniform Anatomical Gift Act, every person has the right to
direct that his or her organs be donated after death. (Although, admittedly,
few do.) Yet, except under extraordinary circumstances, no OPA I know of will
retrieve an organ solely based on such a declaration. Even when a signed donor
card is found (a legally binding document under the Gift Act), the donor's
family is asked to sign a consent form. No hospital, or OPA, wishes to take
the risks of entering into a conflict with a bereaved family. In part, this
represents their unwillingness to increase the family's grief and, in part,
their appreciation of public impact of, say, a bereft mother accusing a
hospital of mutilating her daughter. No single donation is worth that risk.
Requiring people to make a declaration would not change this. A "yes"
would still have to be validated by the family - although such a declaration
would be a significant aid in obtaining their consent. On the other hand, a
"no" would present a virtually insurmountable obstacle to obtaining family
consent. This approach strikes me as exposing the organ donation process to
very high risks for extremely speculative gains.
Most of the same objections can be applied to the "presumed consent"
approach: is it a politically practical step and would it change hospital and
OPA behavior? It certainly has a better chance of changing procurement agency
behavior as it would insulate the procurement process from public attitudes.
On the other hand, its overall impact on the number of organs procured is
unclear. Some European nations already use such a system yet, based on rather
confused data, none appear to do so well as the U.S. in organ procurement. In
745
any case, we are fortunate in this matter as we have others doing the
experimenting already. Certainly an inquiry into the European experience with
"presumed consent" must precede the implementation of this alternative.
"Direct" Incentives for Donors
As an alternative to altering the consent system, several people have
suggested providing direct Incentives to families, or individuals, who agree to
donations. These incentives take a number of forms: direct payments to
families, assumption of certain medical or funeral expenses, tax credits, etc.
I will not attempt to evaluate the advantages and disadvantages of each
alternative but certain general considerations ought to be mentioned. Before
any such system can be considered, three kinds of questions must be answered:
how will it affect those already willing to donate; is it cost effective; and
how will it affect the medical professionals Involved in donor referral?
The most basic question to be asked of any incentive system is whether it
will increase the total number of donations. To a large degree, this will
depend on how it affects those groups presently willing to donate. Some
involved in organ procurement fear that, in the atmosphere of grief and guilt
that surrounds most donations, the suggestion that the survivors might profit
in any way from the donor's death would decrease the likelihood of permission.
Whether this impressionistic view is valid remains to be tested, as does the
different effects of various ways of providing direct incentives to donors or
their families.
A second relevant issue is cost. Presently, some 2200 donors are obtained
each year without payment. If each of these were paid, say $500, the
government would have to spend $1.1 million simply to be where we are now.
746
This would be a good investment if the total number of donations went up
sharply, a poor one if the total went up only several hundred.
Lastly, it is necessary to consider how paying the donors will affect the
involved medical professionals. All involved in organ donation recognize that
the primary bottleneck is not family permission but donor referral. If the
willingness of nurses and doctors to make referrals is decreased by the
dimunition of altruistic motives on the part of donors, then such a step would
be counter-productive. This, too, is a matter for inquiry.
Direct Incentives for Medical Professionals
The issue of incentives for donor families naturally raises the analogous
issue of such incentives to encourage medical professionals to participate more
actively in the referral process. Direct money payments to such people raises
some difficult ethical and legal issues - although systems much like this are
in use in some places in the U.S. However, the efficacy of alternative types
of incentives (education credits, certifications, employment benefits, etc.)
ought to be considered. The question here is, is it possible to design a
reward package consistent with medical ethics that would increase the
motivation of critical medical professionals. As a practical matter, such a
package would be directed primarily at nurses.
One approach to developing such a package might entail the involvement
of hospital administrations in organ procurement. As employers, the hospitals
may be in a position to provide work-related incentives to nurses without
raising issues of conflicts of interest. Up to now official hospital
involvement in organ procurement has been minimal. Little has been asked of
hospitals and little offered to them. Legal permission to operate a
procurement effort within the institution was required and all that was offered
747
was payment for the use of supplies and facilities.
So a little considered, but possibly very effective, place to initiate an
incentive system into organ procurement is at the hospital level. If we find
that the present voluntary approach is not sufficient, applying incentives to
hospitals as organizations may act both to Increase access to more hospitals
and may also provide an effective methodology for motivating medical
professionals with a minimum of risk. How to obtain this increased help from
hospitals is, once again, a matter that bears inquiry.
bTon-Renal Organs
Before I close, it is important to mention a major change beginning in the
transplantation world and its implications for organ procurement. In the last
several years, there has been progress in the transplantation of non-renal
organs. Both liver and heart transplants are being done frequently at certain
medical centers, the commencement of pancreas transplant programs is being
considered at several others. It may be that, in the next few years, the
transplantation of non-renal organs will represent a significant percentage of
all transplants done in the United States.
Such an eventuality represents an important change in the world of organ
procurement agencies. Throughout this testimony, I have referred to these
agencies as "organ" procurement agencies, and so they refer to themselves.
Legally speaking, however, they are "kidney" procurement agencies. With
trivial expectations, each is totally funded by the End-Stage Renal Disease
Program, a program that only pays for kidney acquisition. In practice,
however, they have already exceeded that limitation. Almost all organ
748
procurement agencies routinely attempt to retrieve corneas and, frequently,
skin and bone as well. The added costs of such efforts are minimal as the
tissue-specific banks usually do the actual excision themselves. All the
agency does is ask permission of the family, make arrangements in the hospital,
and contact the eye, skin or bone bank. Government ignorance or benign neglect
has simply allowed these organ procurement efforts to "piggy-back" on kidney
procurement without cost.
As the number of liver and heart transplants has increased in the last few
years, "kidney" procurement agencies have taken responsibility for locating
these organs as well. The transplant centers needing such organs have
reembursed the agencies for the additional costs. So long as the total number
of non-renal transplants is 2 or 3 percent of the number of kidney transplants,
there is little problem with this informal, ad hoc approach. But what will
occur when the percent is 10 percent, or 30 percent, or even 60 percent!
Clearly, certain policy guidelines are needed.
The government has a limited number of options and a substantial number of
problems to resolve. The present organ procurement system will procure non-
renal organs regardless of government preferences. Indeed, no real
alternatives exist. Parallel organ procurement systems, one for kidneys -
funded by the End-Stage Renal Disease Program - and another procuring non-renal
organs, are clearly an absurdity. What the government must decide, therefore,
is who is going to pay for non-renal organs, how the cost of organ procurement
is to be allocated among different organs, what are permissible charging
procedures for non-renal organs, etc. In short, it must decide exactly what
the relationship between renal and non-renal organ procurement will be and how
that relationship will be played out within the organ procurement agencies.
749
The final form of that relationship will determine the final form of the
nation's organ procurement agencies. For this reason, the capacity of these
agencies to function effectively in this new environment ought to be a factor
in the final policy decision. If these agencies are left to face a dozen
reembursement systems, a dozen organ-sharing systems and several dozen
different payers, they will flounder. Most organ procurement agencies do not
have the managerial or financial expertise to operate such a system, nor would
the impact on organ acquisition cost of such complexity be desirable.
Steps need to be taken in this matter now before the scale of the problem
begins to interfere with organ procurement. At present, only the small scale
of non-renal transplants is keeping that part of the organ procurement effort
from chaos. Laudable attempts by some members of the North American Transplant
Coordinators Organization to develop ad hoc solutions can only be considered a
stop-gap measure; a permanent, effective solution can only come from
Washington.
The problem is a complicated one. It may have important financial
implications for the government. It will certainly play a major role in
defining the shape of the nation's organ procurement system and so it will
affect the availability of organs for transplantation. The final
responsibility lies with HCFA and, as new law may be necessary, the Congres.
The sooner work begins on the important issue, the better.
23-029 0-83-48
750
FOOTNOTES
1. Ogburn, W.F., Social Change, New York, Viking Press.
2. Northrop, A. et al., "The Management of Computer Applications in Local
Government," Public Administration Review: 42:3, May /June 1982.
3. Prottas, Jeffrey, "The Impacts of Innovation: Technological Change in A
Mass Transit Authority." Administration and Society,
(forthcoming) .
4. Fox, Renee and Swagey, Judith, The Courage to Fail, University of Chicago
Press, Chicage, 1978.
5. Jones, Judith, "End-Stage Renal Disease: Can the Government be a Prudent
Purchaser?" National Health Policy Forum, The George Washington
University, Washington, D.C., March 25, 1982. (unpublished).
6. Deber, Raisa, personal ..communication.
7. Aroesty, Jerome, "Demographic Profiles for End-Stage Renal Disease and
Kidney Transplantation." Rand, Santa Monica, 1982.
8. Council on Scientific Affairs, AMA, "Organ Donor Recruitment," Journal of
American Medical Association; 246:19 (November 13, 1981) : 2157-2158.
9. Fox, The Courage to Fail, p. 208.
10. Caplan, Arthur, "Kidneys, Ethics and Politics: Policy Lessons of the
ESRD Experience," Journal of Health Politics, Policy and Law.
Volume 6, Number 3, Fall 1981.
11. Fox, The Courage to Fail, p. 205.
12. Aroesty, Jerome, "Demographic Profiles for End-Stage Renal Disease and
Kidney Transplantation." Page 8.
13. Braudel, Fernand, The Structures of Everyday Life. Harper and Rowe, New
York, 1981.
14. Rettig, Richard, "Implementing the End-Stage Renal Disease Program of
Medicare," Rand Corporation, Santa Monica, September 1980.
15. Bart, K. et al., "Cadaveric Kidneys for Transplantation,"
Transplantation: 31:5:379-387.
16. Demkovich, Linda, "Kidney Dialysis Payments May Be test of Reagan's
Commitment to Competition," National Journal, 12/5/81.
751
FOOTNOTES (Continued)
17. Prottas, Jeffrey, "Encouraging Altruism: Public Attitudes and the
Marketing of Organ Donation." Milbank Memorial Fund Quarterly:
Health and Society, forthcoming.
18. Annual Report, End Stage Renal Disease Second Annual Report to Congress,
1980. Department of Health and Human Services, Health Care Financing
Administration.
19. Chase, Gordon, "Implementing a Human Services Program: How Hard Will It
Be?" Public Policy (Fall 1979).
20. Center for Disease Control, "A Proposal for an Expanded Kidney
Procurement Retrieval Effort," Atlanta, March 1979.
21V Prottas, Jeffrey, "Organizational Effectiveness in Organ Procurement: A
Study of Independent Organ Procurement Agencies," Report to the
Health Care Financing Administration, April 30, 1982.
22. Frey, John, "Missing Ingredient in Sales Training," in Salesmanship
and Sales Force Management, ed . , Burss, A., Hutchinson, S., Harvard
University, Cambridge, 1971.
23. Prottas, Jeffrey, "Encouraging Altruism: Public Attitudes and the
Marketing of Organ Donation."
24. Ibid.
25. Titmus, Richard, The Gift Relationship (New York), Vintage Books, 1972).
26. Bart, et al . "Increasing the Supply of Cadaveric Kidneys for
Transplantation," 31:5:379-387.
27. Decker, Ruth, "Spain's Law Governing Organ Donation." Dialysis and
Transplantation 10:11 (November 1981) pp. 899-900;
Farfor, J. A. "Organs for Transplants: Courageous Legislation" British
Medical Journal 1 (1977) pp. 497-498 (for French law).
752
Mr. Gore. We are really under a time constraint now.
I am going to start your testimony, Winifred Mack. We have a
close and important vote on the floor, and we are going to have to
finish up the hearing by 2 o'clock. So what I am going to do is start
your testimony and then interrupt it for the vote shortly, and then
we will come back and have some brief questions.
So please proceed. We will put your prepared statement in the
record. If you could summarize portions of it, that would be fine.
Ms. Mack. I have cut it down in my verbal testimony.
STATEMENT OF WINIFRED B. MACK, PRESIDENT, NORTH AMERI-
CAN TRANSPLANT COORDINATORS ORGANIZATION, SUNY AT
STONY BROOK
Ms. Mack. Mr. Chairman and members of the committee, as
president of the North American Transplant Coordinators Organi-
zation, I welcome the privilege of testifying before this committee
on behalf of the members of NATCO.
The North American Transplant Coordinators Organization is a
national, nonprofit organization representing 365 professionals in
the United States and several foreign countries. Our dedication is
that there be a better quality of life for thousands of patients with
end-stage organ failure and a respect for those who shared.
NATCO members represent various aspects of the transplant
community, including physicians, nurses, and allied health profes-
sionals working with the organ recipient as well as those whose
main objective is to obtain and distribute the valuable human
tissue so direly needed by the waiting victims of end-stage organ
failure.
To this end, our members provide information to medical person-
nel and the general public regarding all aspects of organ transplan-
tation. In addition, NATCO works to disseminate information con-
cerning new techniques in organ procurement, preservation, and
transplant surgery to its members.
Kidney recovery and transplantation became a reality in 1972
when the Federal Government enacted H.R. 1, which provided,
under medicare, that persons with kidney failure would receive full
medical treatment. To support these activities, a new breed of pro-
fessional known as the transplant coordinator evolved.
Most often, coordinators come from some other health back-
ground. Many of us are nurses or physicians' assistants; some are
medical laboratory technologists; a few from related areas such as
social work or psychology.
With the guidance of transplant surgeons and other physicians
as well as input from the clergy, public relations and media per-
sons, administrators, legal consultants, and other experts, the pro-
file of the transplant coordinator was developed.
Today, although still young by comparison to other groups of
health professionals, NATCO has established a training program
for new coordinators as well as ongoing continuing education pro-
grams to assist in the sharing of information and techniques uti-
lized by its members.
Additionally, several transplant institutions have opened their
doors to other centers wishing to train new personnel.
753
The term "coordinator" aptly describes the essence of our func-
tion, and the role may vary according to institutional needs. Specif-
ic details are in my written testimony.
Some coordinators deal specifically with the transplant recipient.
Other coordinators have responsibilities primarily to organ pro-
curement, which includes development of local hospitals as donor
referral sources. Each procurement center has a 24-hour hotline,
and a coordinator is available day or night to assist the donor hos-
pital with the legal issues, medical management of the donor, ob-
taining consent from the appropriate next of kin, and organizing
the surgical team for the recovery of organs.
If the organ cannot be used by the local transplant organ, using
a national computer system, the coordinator may arrange for shar-
ing and transporting of the recovered organ to another center in a
time period short enough to insure its viability.
Transplant centers have long recognized the need for public edu-
cation. As individuals, or in concert with other organ recovery pro-
grams, their coordinators have developed materials such as bro-
chures, donor cards, bumper stickers, poster campaigns, slide
shows, et cetera, for presentation in schools, local community
groups, civic organizations, churches, health fairs, and the like.
They keep channels of communication open with the media,
being available to answer reporters' questions, perhaps speak on
local and national television and radio programs, and encourage
and/or assist in the development of public service announcements.
Needless to say, one person cannot handle all the responsibilities
described, and many programs have few persons hired under the
general title of transplant coordinator.
It must be recognized, however, that these centers work under
conditions of extreme austerity, and coordinators have learned to
tap all available resources to insure the efficacy of their programs.
Collectively, transplant coordinators, under the aegis of NATCO,
have addressed some of the problems existing on a national level.
On September 23, 1982, NATCO inaugurated a formal system to
disseminate information concerning the need for extrarenal organ
donors to procurement programs throughout the United States and
Canada and to assist transplant coordinators and physicians in the
placement of these organs for transplantation.
Mr. Gore. Ms. Mack, if you could pause there, we will recess for
approximately 7 minutes and come back and finish up your testi-
mony.
Ms. Mack. Fine.
[Short recess taken.]
Mr. Gore. The subcommittee will come back to order.
Ms. Mack, you were proceeding with your statement. Please go
ahead.
Ms. Mack. Thank you, Mr. Chairman.
A recorded telephone message updated approximately twice a
day provides a listing of urgently needed hearts, livers, lungs,
heart/lungs, and pancreata for patients awaiting transplantation
at participating centers.
The 24-ALERT system operates 24 hours a day and gives details
of extrarenal donor requirements including organ needed, blood
type, age, size, cross-match requirements when needed, geographi-
754
cal recovery area, and 24-hour referral number. There are current-
ly 15 transplant centers listing their extrarenal organ needs with
24-Alert.
To date, 24-ALERT has facilitated the recovery and transplanta-
tion of 90 extrarenal organs, including the livers recovered for
Jaime Fiske and Brandon Hall and Justine Pinheiro, cases which
have received recent media attention.
NATCO 24-ALERT is a free, voluntary service easily accessible
by telephone to coordinators in hospitals anywhere in the country
by simply dialing 24-ALERT. I wish to stress, however, that infor-
mal referral of extrarenal organs has been in existence and
common among our members since 1978.
On April 4, 1983, 800-24-DONOR was established by NATCO;
800-24-DONOR is an information and referral number for profes-
sionals, possibly to be expanded for public information in the near
future. Staffed by NATCO members, it is designed to facilitate and
enhance procurement programs throughout the country by refer-
ring the caller to the nearest organ recovery center in his area.
Steps are currently being taken to publicize this number through
professional journals and mailings to the community it will best
serve.
As previously mentioned, the NATCO training and development
course is the only established professional training course provided
for new coordinators at this time. In addition, a desk-side reference
manual is now in the final stages of preparation for use both by
procurement and recipient coordinators.
Annual educational meetings serve to update, improve, and
share current knowledge pertaining to organ procurement, preser-
vation, and transplantation. Recognized leaders from various areas
of transplantation, as well as representatives from governmental
and private agencies, are invited to speak to our membership on
topics of common interest related to procurement, preservation,
general education and clinical application.
All future meetings will be held in conjunction with other impor-
tant meetings of the transplant community, enabling our members
to glean information from these prestigious groups.
In addition to the above major endeavors accomplished by
NATCO, individual committees are working diligently on projects,
short and long term, to attain specific goals and objectives of the
organization.
With the general background of transplant coordinators and
their representative organization, NATCO, presented herein, I feel
qualified to present the following recommendations to this commit-
tee for your consideration.
Although over 30 States have thus far enacted some form of
brain death legislation, for the remaining States, the physicians'
and hospitals' fear of litigation looms ominous. Passage of a brain
death law, and the media attention which generally accompanies
it, also serves to educate the public about this difficult-to-under-
stand phenomenon.
Imagine yourself, Mr. Gore, standing before the grieving family
of an 18-year-old boy who, while on his way to a part-time job, was
shot in the head by a couple of joy riders passing by. The respirator
hisses every few seconds; the cardiac monitor beeps; and the boy
755
lies motionless in his bed. The doctors have just informed his par-
ents that he is dead, but they know there is a heartbeat, and heart-
beat has always meant life to them.
Yesterday, they had a perfectly healthy, normal son. Today, they
are told their son is brain dead, whatever that means. Imagine
yourself trying to explain to this family that brain death is really
death. And then imagine asking them to think of somebody else
and to donate his organs for transplantation. They are frightened,
they are confused, they are angry, and the question which comes to
mind is, "Is our son really dead, or do they just want his organs?"
Brain death legislation will not answer all of the questions all of
the time, but if the issue is out in the open with legal support, it
somehow becomes clearer, and the consideration of organ donation
by individuals before their death becomes more likely.
We suggest that, using the definition recommended by the Na-
tional Conference of Commissioners on Uniform State Laws, you
strongly urge the 50 States to adopt brain death legislation.
Second, although our efforts at a local level in our own donor re-
ferral hospitals have gone a long way, we in this field are painfully
aware of the lack of understanding by our colleagues in the health
professions as to the legal, ethical, and medical issues surrounding
organ donation and transplantation.
We hope that NATCO's 800-24-DONOR number will alleviate
some of the problem. However, we recognize that a more broad-
based program is needed. An aggressive campaign of presentations
such as seminars to groups of professionals via local and national
associations and distribution of written materials would be helpful.
NATCO offers the following specific suggestions: (A) appropri-
ation of funds, perhaps in the form of NIH grants, would assist in
the development of professional educational programs and tools.
(B) Recommendations to State agencies entrusted with the re-
sponsibility of licensing of health professionals that information re-
lated to organ transplantation and donation be incorporated into
curricula and questions pertaining to these issues be included in
certifying examinations.
(C) A requirement that all hospitals receiving medicare reim-
bursement be mandated to have written policies and procedures for
brain death and organ donation.
We have, during these hearings, witnessed the testimony of des-
perate parents anxiously awaiting the availability of a cadaver
donor organ for their children. Our hearts ache for these parents,
and we truly appreciate their need to do all humanly possible to
achieve their goal.
However, transplant coordinators are acutely aware that there
are many Jaime Fiskes and Brandon Halls in this country in need
of livers and thousands of patients awaiting the availability of
renal as well as extrarenal cadaver donor organs.
It is easy to relate to one innocent baby's face as it comes across
the TV screen into our homes. And we as coordinators acknowl-
edge that the plea made for one child indeed increases, albeit only
temporarily, organ donation in general. But what of the mother of
two young children who fears that, for lack of a transplant, she
will not live long enough to see her babies reach adulthood; or the
756
man in whom renal failure has caused sterility and who may never
realize the joy of fathering a child?
It is imperative that the citizens of this Nation become aware
that organ transplantation is a therapeutic modality past stages of
experimentation and a viable alternative to life on a dialysis ma-
chine or blindness or, worst of all, death.
Great concern has been expressed during these hearings as to
the equitability of organ distribution to the waiting recipients. Sug-
gestions have been made in the form of a computerized matching
system or a first-come, first-served basis.
National systems such as the computer available through the
United Network for Organ Sharing, or NATCO's 24-ALERT, al-
ready exist to facilitate the most effective utilization of recovered
donor organs. It must be appreciated, however, that in the world of
medical science, a computer is only a tool to assist but not to sub-
stitute for the trained clinical judgment which must be exercised in
the care of the human patient.
In varying degrees, depending on the specific organ in question,
recipient selection is made on the basis of tissue matching, medical
urgency, length of time a patient may be waiting on the list, geo-
graphical location, donor-versus-recipient age, size and weight, or
any combination of these factors. What looks good in the computer
printout is not necessarily good in clinical application.
The family that donates an organ with the expressed intention
that it go to a particular recipient, or even a patient of the same
race, ethnic background, or age of the donor should be told that
such stipulations might result in the inability to find such a com-
patible recipient, or, more importantly, the inevitable rejection of
that transplanted organ.
Education of the general public about specific advances in ther-
apy have often resulted in pressure on the medical community to
utilize new techniques or alter long-accepted practices. We believe
that mass public education will raise the consciousness of Ameri-
can citizens, help them to more fully understand the complexity of
these issues, and ultimately stop the senseless waste of valuable
human tissues.
NATCO makes the following suggestions:
(a) A national coalition of organizations who have interest in the
recovery of human organs — eyes, skin, kidneys, liver, heart, bone,
et cetera — could pool their efforts and expertise to produce both
public and professional educational materials on all aspects of
organ donation and transplantation.
With input from the fields of medicine, advertising, media, and
public relations, fundraising, law, clergy, et cetera, a national cam-
paign could be launched to provide this informational source. Once
again, money in the form of grants could be used to seed this
agency.
(b) NATCO's Education Subcommittee for Public Education has
worked with both the National Kidney Foundation and the Ameri-
can Medical Association to increase organ donation. This year, the
first session of the 98th Congress introduced Senate Joint Resolu-
tion 78, to authorize and request the President to issue a proclama-
tion declaring this week, April 24-30, 1983, as National Organ Do-
757
nation Awareness Week. We ask this committee to recommend
that such a week be identified annually.
Finally, the Members of Congress, each represent leadership in
their local constituencies. We urge this committee to request each
of its colleagues to return to their home States, ask for time from
their local television stations, and publicly sign an organ donor
card such as the one you have before you.
This demonstration of moral leadership by political leaders will
go a long way in establishing organ donation as a natural sequel to
death.
I thank you very much.
[The prepared statement of Ms. Mack follows:]
758
TESTIMONY OF
WINIFRED B. MACK, PRESIDENT
NORTH AMERICAN TRANSPLANT COORDINATOR'S ORGANIZATION
MR. CHAIRMAN, MEMBERS OF THE COMMITTEE:
My name is Winifred B. Mack, R.N. , B.S.N. , M.P.A. (candidate) , President of
the North American Transplant Coordinator's Organization and a Transplant Coordin-
ator at the State University of New York, University Hospital at Stony Brook, Long
Island, New York. I welcome the privilege of testifying before this canmittee
on behalf of the members of NATCO.
The North American Transplant Coordinator's Organization (NATCO) is a
national, non-profit organization representing 365 professionals in the United
States and several foreign countries. Our dedication is "that there be a better
quality of life for the thousands of patients with end-stage organ failure. . .
and a respect for those who shared." NATCO members represent various aspects
of the transplant cortinunity, including physicians, nurses and allied health pro-
fessionals working with the organ recipient, as well as those whose main objective
is to obtain and distribute the valuable human tissue so direly needed by the
waiting victims of end-stage organ failure. To this end, our members provide
information to medical personnel and the general public regarding all aspects
of organ transplantation. In addition, NATCO works to disseminate information
concerning new techniques in organ procurement, preservation and transplant sur-
gery to its members.
Kidney recovery and transplantation became a reality in 1972, when the
Federal Government enacted HR-1, which provided, under Medicare, that persons
with kidney failure would receive full medical treatment. To support these
activities, a new breed of professional, known as the Transplant Coordinator,
evolved. Most often coordinators come from some other health background - many
of us are nurses or physician's assistants, sane are medical laboratory technolo-
gists, a few are fan related areas such as social work or psychology. With the
guidance of transplant surgeons and other physicians, as well as input from
I
i
759
clergy, public relations and media persons, administrators, legal consultants
and other experts, the profile of the Transplant Coordinator was developed. Today,
although still young by comparison to other groups of health professionals, NATCO
has established a training program for new coordinators, as well as on-going
continuing education programs to assist in the sharing of information and tech-
niques utilized by its members. Additionally, several transplant institutions
have opened their doors to other centers wishing to train new personnel.
The role of a Transplant Coordinator may vary according to institutional
needs. Some coordinators deal specifically with the transplant recipient, assist-
ing the physicians with the determination of medical suitability, arranging for
necessary laboratory and diagnostic testing, comnuni eating with other health
care providers (physicians, dialysis units, etc.) to keep current on the status
of the patient, providing for the collection of frequent blood samples for tissue
matching with specific donor organs, and educating and preparing the patient
emotionally and otherwise for the future transplant procedure.
Other coordinator's have responsibilities primarily to organ procurement.
This may include development of local hospitals as donor referral sources by
meeting with administrators, medical boards, nursing and other ancillary personnel
to assist in the formulation of policies and procedures for the determination of
brain death and organ donation. Frequent surveillance visits and continuing-
education programs are offered as a means of keeping organ donation "alive"
in the minds of the professionals in these hospitals. Coordinators develop
protocol manuals, posters, slide shows, telephone stickers, etc., for distribu-
tion in hospital emergency rooms, critical care units and the like. Each pro-
curement center has a 24 horn: "hot line" and a coordinator is available day or
night to assist the donor hospital with the legal issues, medical management of
the donor, obtaining consent from the appropriate next-of-kin, and organizing the
surgical team for the recovery of the organs.
760
VJhen the organs are obtained, coordinators may be present in the operating
room to help in their preparation and preservation for transplantation. Within
the transplant center they may arrange for the final cross-matchng and then
admission of the sui table recipient. Alternatively, if the organ cannot be used
by the local transplant program, using a national computer system, the coordinator
may arrange for the sharing and transporting of the recovered organ to another
center - all in a time period short enough to ensure its viability.
Transplant centers have long recognized the need for public education. As
individuals, or in concert with other organ recovery programs, their coordinators
have developed materials such as brochures, donor cards, bumper stickers, poster
campaigns, slide shows, etc., for presentation in schools, local connrunity groups,
civic organizations, churches, health fairs and the like. They keep channels of
cornnunication open with the media, being abailable to answer reporters' questions,
perhaps speak on local or national television/radio programs, and encourage
and/or assist in the development of public service announcements.
Needless to say, one person cannot handle all the responsibilities described
and many programs have a few persons hired under the general title of Transplant
Coordinator. It must be recognized, however, that - these centers work under
conditions of extreme austerity and coordinators have learned to tap all available
resources to ensure the efficacy of their programs.
Collectively, Transplant Coordinators, under the aegis of NATCO, have
addressed some of the problems existing on a national level:
1. NATCO 's 24-ALEKT On September 23, 1982, NATCO inaugurated a formal
system to disseminate information concerning the need for extrarenal organ donors
to procurement programs throughout the United States and Canada, and to assist
transplant coordinators and physicians in the placement of these organs for trans-
plantation. A recorded telephone message, updated approximately twice a day, pro-
vides a listing of urgently needed hearts, livers, lungs, hearts /lungs, and
pancreata for patients awaiting transplantation at participating centers. The
761
24-ALERT system operates 24 hours a day, and gives details of extrarenal donor
requirements including organ needed, blood type, age, size, cross-match require-
ments when needed, geographical recovery area and 24 hour referral number. There
are currently 15 transplant centers listing their extrarenal organ needs with
24 ALERT. To date 24 ALERT has facilitated the recovery and transplantation
of 90 extrarenal organs (34 hearts, 55 livers, 1 heart/lung block) including the
livers recovered for Jamey Fiske, Brandon Hall, and Justine Pinheiro, cases which
have received recent media attention. NATCO 24 ALERT is a free, voluntary service,
easily accessible by telephone to coordinators in hospitals anywhere in the country
by simply dialing 412-24 ALERT. Institutions who wish to add a potential recipient
to the recorded message, may do so by dialing 412-366-6777. I might add that
informal referral of extrarenal organs has been in existance and common among
our members since 1978.
2. NATCO' s 800-24-DONOR On April 4, 1983, 800-24 DONOR was established by
NATCO. 800-24 DONOR is an information and referral number for professionals,
possibly to be expanded for public information in the near future. Staffed by
NATCO members, it is designed to facilitate and enhance procurement programs
throughout the country by referring the caller to the nearest organ recovery
center in their area. Steps are currently being taken to publicize this number,
through professional journals and mailings (Journal of the American Medical Associ-
ation, April 15, 1983) , to the community it will best serve.
3. NATCO TRAINING AND DEVELOPMENT COURSE As previously mentioned, this is
the only established professional training course provided for new coordinators
at this tine. In addition, a desk-side reference manual is now in the final stages
of preparation for use by both procurement and recipient coordinators.
4. NATCO ANNUAL MEETING Annual educational meetings serve to update, improve,
and share current knowledge pertaining to organ procurement, preservation, and
transplantation. Recognized leaders from various areas of transplantation, as
well as representatives from governmental and private agencies are invited to speak
762
to our membership on topics of common interest related to procurement and pre-
servation, general education and clinical application. Meetings are held in
plenary and simultaneous sessions and workshop format, and active participation
by attendees is encouraged. All future meetings will be held in conjunction
with other important meetings of the transplant corrnunity (i.e. , American Society
of Transplant Surgeons, The International Congress of The Transplant Society) ,
enabling our members to glean information from these prestigious groups.
5. In addition to the above major endeavors accomplished by NATCO, individual
committees are working diligently on projects, short and long term, to attain
specific goals and objectives by the organization.
With the general background of Transplant Coordinators and their representa-
tive organization, NATGO, presented herein, I feel qualified to present the following
recommendations to this ccnmittee for your consideration:
1. BRAIN DEATH LEGISLATION Although over 30 states have thus far enacted some
form of brain death legislation, for the remaining states the physicians' and hos-
pitals ' fear of litigation loom ominous . Passage of a brain death law, and the
media attention which generally accompanies it, also serves to educate the public
about this difficult to understand phenomenum. Imagine yourself, Mr. Gore, standing
before the grieving parents of an 18-year old boy who, while an his way to a part-
time job one Saturday morning, was shot in the head by a couple of "joy riders" in .
a passing car. The respirator hisses every few seconds sending oxygen into his
otherwise unmoving lungs. The steady beep of the cardiac monitor drones on as the
boy lays motionless in his bed. The doctors have just informed these parents that
their son is dead, but they know there's a heartbeat, and heartbeat has always
meant life. Yesterday they had a perfectly healthy, normal son - today they are
told "he is brain dead," whatever that means. Imagine yourself trying to explain
that brain death is really death - and then imagine asking them to think of some-
one else and to donate his organs for transplantation. They're frightened, they're
763
confused, they're angry. And the question which comes to mind is, "Is our son
really dead, or do they just want his organs?"
Brain death legislation will not answer all of the questions all of the time,
but if the issue is out in the open, with legal support, it somehow becomes
clearer, and the consideration of organ donation by individuals before their death
becomes more likely. We suggest that, using the definition reoonnended by the
National Conferrence of Commissioners on Uniform State Laws, you strongly urge all
50 states to adopt brain death legislation.
2. PROFESSIONAL EDUCATION Although our efforts at a local level in our own
donor referral hospitals have gone a long way, we in this field are painfully aware
of the lack of understanding by our colleagues in the health professions as to the
legal, ethical and medical issues surrounding organ donation and transplantation.
We hope that NATCO's 800-24 DONOR will alleviate some of the problem. However, we
recognize that a more broad-based program, geared towards professional education
and information is needed. Presentation such as seminars to groups of professionals
via local and national associations, and distribution of written materials would
be helpful.
NATCO offers the following specific suggestions:
A. Appropriation of funds, perhaps in the form of N. I. H. grants, would assist
in the development of professional educational programs and tools.
B. Reccmtendations to state agencies entrusted with the responsibility of the
licensing of health professionals, that information related to organ transplantation
"and donation be incorporated into curricula and questions pertaining to these
issues be included in certifying examinations.
C. A requirement that all hospitals receiving Medicare reijrbursement be man-
dated to have written policies and procedures for brain death and organ donation.
3. PUBLIC EDUCATION We have, during these hearings, witnessed the testimony
of desperate parents, anxiously awaiting the availability of a cadaver donor organ
for their children. Our hearts ache for these parents, and we truly appreciate
764
their need to do all humanly possible to achieve their goal. However, Transplant
Coordinators are acutely aware that there are many Jamey Fiskes and Brandon Halls
in this country in need of livers, and thousands of patients awaiting the availability
of renal as well as extrarenal cadaver donor organs. It is easy to relate to one
innocent baby's face as it comes across the TV screen into our homes. And we as
coordinators acknowledge that the plea made for one child, indeed increases, albeit
only temporarily, organ donation in general. But what of the mother of two young
children who fears that for the lack of a transplant she'll not live long enough
to see her babies reach adulthood. Or the man in whom renal failure has caused
sterility and who may never realize the joy of fathering a child. It is impera-
tive that the citizens of this nation become aware that organ transplantation is
a therapeutic modality, past the stage of experimentation and a viable alternative
to life on a dialysis machine, or blindness, or worst of all, death.
Great concern has been expressed during these hearings as to the equitability
of organ distribution to the waiting recipients. Suggestions have been made in the
form of a computerized matching system, or a 'first-come, f ixst-served ' basis.
National systems, such as the computer available through the United Network for
Organ Sharing (UNOS) , currently accessed by approximately 140 centers, or NATCO's
24 ALERT, already exist to facilitate the most effective utilization of recovered
donor organs. It must be appreciated, however, that in the world of medical
science, a computer is only a tool to assist, but not to substitute for, the
trained clinical judgement which must be exercized in the care of the human patient.
In varying degrees, depending on the specific organ in question, recipient selection
is made on the basis of tissue matching, medical urgency, length of time a patient
may be waiting on the list, geographical location (re: time for transporting) ,
donor vs. recipient age, size and weight, or any combination of these factors.
What looks good in the computer print-out is not necessarily good in clinical
765
application. The family that donates an organ with the expressed intention that
it go to a particular recipient, or even a patient of the same race, ethnic
background or age of the donor, should be told that such stipulations might
result in the inability to find such a compatible recipient, or more importantly,
the inevitable rejection of the transplanted organ.
Education of the general public about specific advances in therapy have oft
resulted in pressure on the medical community to utilize new techniques or alter
long-accepted practices (e.g., the use of routine manography as a prophyllactic
diagnostic test for breast cancer) . We believe that mass public education will
raise the consciousness of the American citizen, help him/her to more fully
understand the complexity of these issues, and ultimately stop the senseless
waste of valuable human tissues.
NATCO makes the following suggestions:
A. A national coalition of organizations who have interest in the recovery of
human organs - eyes, skin, kidneys, liver, heart, bone, etc., could pool their
efforts and expertise to produce both public and professional educational materials
on all aspects of organ donation and transplantation. With input from the fields
of medicine, advertising, media and public relations, fund-raising, law, clergy,
etc., a national campaign could be launched to provide this informational source.
Once again, money in the form of grants, could be used to seed this agency.
B. NATCO 's Education subcommittee for Public Education has worked with both
the National Kidney Foundation and the American Medical Association to increase
organ donation. Ihis year, the first session of the 98th Congress passed S.J.
Resolution 78, to authorize and request the President to issue a proclamation
declaring April 24-30, 1983, as National Organ Donation Awareness Week. We ask
this committee to recommend that such a week be identified annually.
C. Finally, the members of Congress each represent leadership in their local
constitutiencies . We urge this committee to request each of their colleagues to
return to their hone states, ask for time form their local television stations, and
publicly sign an organ donor card, such as the one you have before you. This
demonstration of moral leadership, by political leaders, will go a long way in
establishing organ donation as a natural sequel to death.
766
Mr. Gore. Thank you very much. We appreciate that excellent
testimony. Many of your recommendations, I am certain, will be in-
cluded in the report and the recommendations of the subcommit-
tee.
I would also like to thank my constituent, Sherry Park, pioneer
in tissue typing work, for her assistance in making your testimony
possible here today.
We are running very short on time, and I am sorry about that,
but let me just ask a couple of brief questions.
Dr. Sell, I should point out that you are an imminent and inter-
nationally recognized immunologist, and you are in fact the scien-
tific director of the National Institute of Allergy and Infectious Dis-
eases. Is that correct?
Dr. Sell. That is correct.
Mr. Gore. So when you project that the dramatic advances in im-
munosuppression which have occurred recently are but a stage on
the way to complete prevention of graft rejection in only a few
years, we ought to take that prediction pretty seriously.
Do you believe that it is just a few years before graft rejection
will be a thing of the past?
Dr. Sell. Certainly, we anticipate that the vast increase in im-
munological research which is going on now will enable us to iden-
tify the elements of the immune system and better control them.
We anticipate that in the foreseeable future, maybe not the next
few years but certainly in the next decade, we will see ways of con-
trolling this immune response that are far superior to the ways
that we have today.
For example, we already have, through the new biotechnologies,
ways of making very specific antibodies to hit very specific targets
in the immune system. While these have not yet been used with
complete success, we do note that places like the Mass General
Hospital already are exploring these methods for controlling the
rejection episodes which still occur despite the immunosuppressive
agents that are currently available, including cyclosporin.
Mr. Gore. Some of the figures we received 2 weeks ago indicate
that the incidence of rejection has already dropped dramatically,
and it is just a new era.
You mentioned in that regard that you expect to see an explosive
increase in the demand for organs for purposes of transplantation.
Do you have any way of estimating the numbers involved, and
could you tell us whether or not the present system is at all capa-
ble of dealing with this?
Dr. Sell. I am perhaps not the best one to respond to that. I
cannot give you exact figures. The comment in my testimony really
had to do with the fact that if we can control the immune rejection
without using nonspecific toxic immunosuppressive agents that we
currently have available, we will be able to extend transplantation
to deal with problems that are not necessarily life threatening.
This will expand the patient populations greatly and therefore
expand the need beyond even those that have been discussed so
widely by other members of this panel and others who have testi-
fied at this meeting.
To estimate the total need would be difficult. We are certainly
talking in terms of tens of thousands of people.
767
Mr. Gore. Congressman Reid?
Mr. Reid. I have no questions, Mr. Chairman.
Mr. Gore. We are going to have a comprehensive report with
recommendations on a national strategy, and many of the recom-
mendations that you have made on this panel will be included in
our report. The recommendations of other witnesses who have ap-
peared during the 3 days of this series of hearings will in large
part also be included.
I hope that we can look forward to the day, not long from now,
when we will have a national strategy to enhance the awareness of
organ donation and how important it is to sustain life.
I think there are many things that obviously can be done right
away, and I hope that these hearings have helped, and I hope that
our report will help further.
I would like to thank the members of our last panel for their
contribution here today, and I would like to thank all of the wit-
nesses who have appeared during the 3 days of testimony. We will
look forward to continuing our work with many of you and many
of those others who have appeared here in our joint efforts to try
to solve these problems.
Thank you very much. The hearing is adjourned.
[Whereupon, at 2:14 p.m., the subcommittee recessed, to recon-
vene at the call of the Chair.]
APPENDIX
Additional Material Submitted for the Record
AMERICAN ASSOCIATION OF CRITICAL-CARE NURSES
Joanne Dttch. RN, MSN. CCRN
Ova &*u RN MN. CCRN
iMtt Sampson RN CCRN
JOVC* P "jnflin RN. MSN. CCRN
EXECUTIVE CM RECTOR
Edward A Shaw. MBA, PriO
a Kirfw RN. MS, CCRN
Ramon Lavandara RN, MA. MSN CCRN
Linda MM. RN. MSN, CCRN
Sinn Ruppert RN, MSN. CCRN
Sarah Sanf ord, RN. MA. CCRN
Elzabarh J Schaurar. RN. CCRN
Laura Ymxiq. RN. BSN. CCRN
April 27, 1983
The Hon. Albert Gore, Jr.
Subcommittee on Investigation
and Oversight
Committee on Science and
Technology
U. S. House of Representatives
House Annex 1, Room 822
Washington, DC 20515
Dear Congressman Gore:
On behalf of the American Association of Critical -Care Nurses,
I am pleased to submit the attached document, "Organ Procurement:
The ICU Nurse's Perspective," for use in your consideration of
the issues related to organ procurement. I must confess to
disappointment that time did not allow us an opportunity to
present our testimony during the hearings. Input from nurses
who are among the most significant links in the procurement
process is essential. Nevertheless, we are very pleased to be
able to offer this document and would hope that, should other
hearings be arranged, there might be time available for us to
present.
Thank you again for the opportunity to share this information
with you. I look forward to seeing the recommendations of
the hearings. If there is any further way in which I or the
association can help in the future, I would consider it a
privilege to do so.
Sincerely,
(/Joanne Disch, RN, MSN, CCRN
President
JD/enf
Att.
National Office: One Civic Plaza, Newport Beach, California 92660 • (714) 644-9310
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<9
ORGAN PROCUREMENT
THE ICU NURSE'S PERSPECTIVE
Organ transplants have long left the experimental days.
At present, they maintain a high rate of success as a major
surgical intervention to increase the quality and quantity
of life for those suffering from severe organ dysfunction
or failure. Sophistication in surgical techniques and
developments in immuno-suppressive therapy have greatly
increased the success of tranplantation of human organs
(Cleveland, 1975) . Unfortunately, relatively few of the
chronically ill awaiting transplants actually receive organs.
The problem appears to lie in the identification and referral
of organ donors, not in their availability.
An annual estimated 20,000 Americans die suddenly from
brain tumors, injury or strokes and have the potential to
become organ donors (Stuart et al, 1981) . These critically
ill and neurologically impaired patients usually require
intensive care units (ICUs) for the first few days. The
nurses in the ICU have a very unique role. The high nurse/
patient ratio (i.e., one nurse for one or two patients)
enhances the comprehensive care of all aspects of the patient's
physical illness and resulting psychosocial problems.
Critical care nurses are in a position to identify, facilitate
and complete the referral process of organ procurement.
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This paper will present an overview of various aspects
of the problem, the role of the ICU nurse, impeding factors
in the process and recommendations for improvement.
SCOPE OF THE PROBLEM
Cadaver donor transplantation has become an accepted
surgical intervention to treat organ failure. Skin, corneas,
livers, hearts and kidneys can be procured from appropriate
donors. However, only a small percentage of the needed
organs is obtained.
For example, more than 60,000 Americans presently
suffer from irreversible renal (kidney) failure and are
dependent upon hemodialysis to maintain life. Hemodialysis
requires the patient to be placed on a machine that does
the job of his nonfunctioning kidneys for four hours a day,
three times a week. It costs the patient almost $28,000
a year to maintain such therapy. In contrast, a kidney
transplant costs approximately $20,000 initially and $1,000
per year to maintain (Burns, 1980). Familial donors are
first approached but, due to incompatibilities, over 75%
are cadaver transplants (Renal Network Coordinating Council,
1982) .
Of the 20,000 possible donors mentioned earlier, only
16% of those kidneys are actually obtained (Stuart et al,
1981) . The supply does not come close to meeting the demand
of organ transplant recipients.
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Transplant centers have been developed to help facilitate
the referral process; however, the number of referrals still
remains low. Legal, logistical, ethical and personal
obstacles of all involved seem to stand in the way of the
actual donation. The nurse in the ICU setting has to deal
with many of these obstacles.
A study conducted by the Center for Disease Control
showed that over 74% of potential donors died in critical
care units (Renal Network Coordinating Council, 1982). Due
to the critical and usually sudden nature of the disease,
the patient is placed in the ICU for careful monitoring of
his vital signs, respiratory management and complete v
neurological assessment. The registered nurse is the person
primarily responsible for the patient's total physical and
psychosocial care. For an 8-12 hour shift, the nurse
concentrates her efforts on the care of just one or two
patients. She is responsible for caring for his wounds,
maintaining lines and support equipment, monitoring vital
signs, assisting the physician in diagnostic procedures
and supporting the family. The nurse is responsible for
continuity of care of the patient and his family and is
constantly looking for signs of improvement.
There are a multitude of factors involved in the organ
procurement process. The following section will focus on
one of the variables, the role of the ICU nurse and the
specific problems relating to the referral process.
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THE ICU NURSE: ROLE AND PROBLEMS
The Decision for Donation: Individual and Family
The decision for organ donation is a difficult one for
both the individual and family. The nurse, an informed
individual in health care, often struggles with the personal
commitment to organ procurement. She is involved with a
personal decision making process, as well as in professional
practice in assisting the family with a difficult decision.
As the public become aware of the successes of organ
donations, a positive attitude toward the issue evolves
(Cleveland, 1975). 70% of the population stated that they
were willing to donate organs. 80.7% of nurses surveyed
stated that they would be donors, but only 28.2% actually
carried donor cards (Sophie et al , 1983). Although
cognitively, organ donation appears to be logical, nurses
as well as others find it difficult to anticipate their
own death and thus make a written commitment regarding their
organs. The donor card is a legal document under the Uniform
Anatomical Gift Act. The witnessed signature on the card
lets others know of a desire to become an organ donor in the
event of sudden death (Kidney Foundation, 1980)- It is a
relatively simple procedure but a deeply personal decision.
There is something very unsettling in making preparations
for one's own death. Freud theorized that subconsciously
everyone believes in his own immortality. It is a difficult
thing to accept and is left incomplete by many.
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Consequently, in cases of severe illness or irreversible
brain injury, the decision for organ donation is left up to
the family. Family members are in crisis as they await
progress reports on the patient. Reports of 'brain death*
introduce a new dilemma. The usual definitions of death,
which to many mean the cessation of a heartbeat and breathing,
are incongruous with the concepts introduced in the definition
of 'brain death." Families visit the patient in the ICU and
observe the multitude of equipment and tubes required for his
care. He is comatose but shows some evidence of breathing
(ventilator-assisted) and a heartbeat. It is difficult for
families to realize that his brain has ceased to function.
The ICU nurses become primary support people for families
during this time. Nurses are frequently at the patient's
bedside along with the family and become an available resource
for questions, progress reports and reassurance. The environ-
ment of the ICU with its monitors, machinery, intermittent
alarms and incomprehensible blips is often frightening for
family members. The nurse takes time to explain and re-explain
all that is being done and what the monitors mean. She
reassures them that most support machinery is not as uncomfor-
table as it seems and is there to facilitate the care of the
patient.
During the crucial first one to three days in the ICU, a
rapport and relationship are established between the nurse
and the family. The family begins to relax and share their
(V^T) National Office One One Plaza, Newport Beach, California 92660 ■ (714)644-9310
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feelings and their experiences about the patient. Through
his family, the nurse gets to know the patient as a person.
The patient no longer exists as a 'body with a disease' but
as a person with a career, family and personality. Thus,
over a short period of time, the nurse becomes intensely
involved with and committed to both the patient and the
family.
Ethical Considerations
Ethical problems are not new to an ICU. Health care
education has emphasized the preservation of life and
functioning whenever possible (Cohen, 1977) . Dilemmas in
care are faced by the ICU nurses constantly in the care of
transplant donors. Once a diagnosis of brain death is
confirmed, the goals for treatment of the patient change.
Neurological patients are usually kept semi-dehydrated to
control cerebral edema (swelling) and undergo frequent
neurological exams to check for improvements or deterioration
in condition. Once brain death has been declared and
permission for a donor organ is obtained, the patient is
rehydrated to maximize kidney function, neurological checks
are discontinued and cardiovascular and respiratory functions
are supported specifically for the preservation of the
kidneys (or other organs) . Some nurses fear making an
error in the management of the patient at this time due to
a lack of familiarity with the policy and protocols of organ
procurement (Sophie, et al, 1983) .
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In addition, 21% of the nurses surveyed felt that it was
emotionally draining to have to care for a 'dead' body for
eight hours or more. The nurse has gotten to know the patient
through the family and in her mind, he is not just a body.
Up to now, the energy spent by the nurse has been for the
preservation of life, looking for signs of recovery and
hoping with the family for improvement. The diagnosis of
brain death is often disappointing and frustrating.
The patient is also occupying a bed space that may be
needed by someone healthier with a chance of survival. A
basic philosophical question arises: Should an ICU be
used for the purpose of maintaining cadaver transplants
while other patients await an ICU bed?
Nursing staff frequently becomes involved in bed space
issues and room assignments of incoming patients. Depending
upon the severity of the illness and the requirements for
care, nurses set priorities on the utilization of bed space
and thus nursing staff.
The nurse is often caught in the middle of an interdepart-
mental transfer of patients. For example, an ICU may not be
able to accept a patient from the emergency room due to a lack
of beds. A possible bed can be opened as soon as the trans-
plant team arrives to care for the donor organ. Meanwhile,
the waiting patient is cared for in the emergency room or
in another department which may not be an appropriate area
for the care required. It is an added stressor for the nurses
in that department.
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Donor Identification Process
The nurse remains the primary person in identifying
possible donors. Sophie et al (1983) surveyed 312 ICU
nurses on their perceptions of their role in organ procure-
ment, personal feelings and baseline knowledge. 63% felt
that nurses were the first to recognize possible donors, but
felt the ultimate decision for referrals be made by the
physician (65%) and the approach to the family should also
be made by the physician (79%) . She also found this group
very knowledgeable about the criteria for organ donation,
but about 25% of them did not know the policy for referral
in their hospital. They were also unaware of the attitudes
of the neurologists and neurosurgeons working in the unit.
Nurses possess the knowledge and awareness to recognize
possible donors, but the physician is usually the person to
approach the family. The physician, however, may also be
dealing with his feelings about the loss of his patient
and/or be unable to make the commitment to the diagnosis of
brain death (Stuart et al, 1981) . This physician may have
been caring for the patient for many years. A sudden death
may be equally traumatic for him as for the family and the
nurse. He may find it difficult to discuss the options
objectively with the family even if the family has introduced
or accepted the idea.
The organ procurement process is often a complicated and
extensive procedure. The physician may not want to make
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National Office: One Civic Plaza, Newport Beach, California 92660 • (714) 644-9310
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AMERICAN ASSOCIATION OF CRITICAL-CARE NURSES
things any more difficult for himself and the family by
having to deal with the needs of the transplant team.
The care of the patient is a collaborative effort between
the nurse and the physician. It becomes a problem for
families when there are inconsistencies in messages given
them about any facet of the patient's condition. Families
look to the nurse/physician team for support and stability.
Family stress and disorganization are intensified when a
discussion of important issues is conflicting or nonexistent.
This frequently occurs when the grief of the physician
becomes an obstacle in communication in the organ procure-
ment process.
Lack of Rewards
A minority (25%) of nurses stated that caring for such
patients is rewarding (Sophie et al, 1983). A retrospective
study on donors' families was done by Morton and Leonard in
1979. All families were pleased with their decision to allow
the donation, an option many would not have considered had
someone not suggested it. The most comfort came from the
knowledge that they had either fulfilled the patient's wish
or that something tangible and positive had come out of his
death.
The family often receives feedback about the results of
the organ transplant. The nurse caring for the patient may
not receive such feedback. Her memory of the final outcome
of the patient's stay in the ICU is a picture of him being
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taken to surgery to remove the donor organs. It is an
unfinished termination of the nurse's relationship with the
patient.
The roles of nurses in an ICU are as patient advocate,
care giver and educator of patient and family to facilitate
the adaptation to his illness. In order to do this, the
nurse must deal with her own grief and loss over losing a
patient. Timing of each step in the organ procurement
process becomes important. The family as well as the nursing
and medical staff must be allowed time to accept the situation.
It is often difficult for the nurse to keep an objective
perspective on all these factors in an extremely busy and
stressful environment.
RECOMMENDATIONS
The overall goal is to stimulate the nurse and physician
to notify the transplant team about potential donors. The
enhancement of the goals of the organ procurement process
must be viewed from a collaborative nurse-physician perspec-
tive. The following recommendations are made based on this
concept.
(1) Prepare nurses and physicians through continual
staff education. Educational series need to encompass
hospital procedures and criteria for donor referral,
the availability and function of the transplant team
(and coordinator if one is available) , responsi-
bilities and interrelationships of other departments,
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and a baseline knowledge of ethical issues involved.
It will also be helpful to provide guidelines in
dealing with the family's grief response.
(2) Provide avenues for nurse and physician support.
This support can be in the form of positive feedback
on the outcome of recipients, visits to the donor
center (Sophie, 1983) , a reliable support person
to assist nurses and physicians in dealing with
their grief and loss and perceptions regarding the
changing goals of patient care. An ethics committee
can also function as a support system for the
health team.
(3) Increase consistency of in-hospital family support.
Time is of the essence in the decision making process
for all involved. Additional family counseling such
as a psychiatric liaison or clergy may be helpful
at this time.
(4) Ongoing public education. As public awareness on the
subject increases, initiation of donations from the
patient and family may increase (Van Hook, 1982).
CONCLUSIONS
The present system of organ procurement is failing to
meet the needs of a large population of transplant recipients.
The problems lie in the many variables involved in obtaining
organs for donation, not in the availability. Most decisions
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AMERICAN ASSOCIATION OF CRITICAL-CARE NURSES
occur amidst a highly stressful environment and during a
critical time in the patient's and family's lives. The
various factors from the perspectives of ICU nurses have
been discussed.
It is obvious that the nurse plays a major role in
facilitating the organ procurement process. It is imperative
to recognize this role and support the nurse and physician
in a collaborative effort in increasing referrals. Recom-
mendations were stated to enhance this overall goal in
facilitating the process of organ procurement.
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BIBLIOGRAPHY
Burns, Carol. "Nurses, the Key To Obtaining Renal Donations."
Nephrology Nurse. October 1980, p. 974.
Cleveland, Signdy E. "Changes in Human Tissue Donor Attitudes:
1969 - 1974." Psychosomatic Medicine. Vol. 37, No. 4,
p. 306. July/August 1975.
Cohen, Cynthia B. "Ethical Problems of Intensive Care."
Anesthesiology. 17: 217-227, 1977.
Kidney Foundation of Southern California. "Your Driver's
License Could Save Someone's Life." January 1980. A
pamphlet published by the Northrop Corporation.
Morton, J. B. and D. R. Leonard. "Cadaver Nephrectomy: An
Operation on the Donor's Family." British Medical Journal.
January 27, 1979, p. 239.
Council on Scientific Affairs. "Organ Donor Recruitment."
JAMA. November 13, 1981, Vol. 246, No. 19, p. 2157.
Peele, Amy S. "Organ Procurement: Current Trends and
Philosophies" from Comprehensive Nephrology Nursing.
C. J. Richard, ed . Little, Brown & Co. (in press)
Renal Network Council of the Upper Midwest. Give to the
Future -- Support Organ Donation, Hospital participation,
(pamphlet) April 1982.
Schulman, Barbara. Transplant Coordinator, UCLA Medical
Center, Los Angeles, California. Personal communication,
1983.
Smith, Susan, R.N. Clinical Nurse Specialist, UCLA Medical
Center, Los Angeles, California. Personal communication,
1983.
Sophie, Laura Ruse et al. "Intensive Care Nurses' Percep-
tions of Cadaver Organ Procurement." Accepted for
publication in Heart & Lung, 1983 (in press) .
Stuart, Frank P. and Frank J. Veith and Ronald E. Canford.
"Brain Death Laws and Patterns of Consent To Remove
Organs for Transplantation from Cadavers in the United
States and 28 Other Countries." Transplantation. Vol. 31,
No. 4, p. 238, 1981.
National Office: One Civic Plaza, Newport Beach, California 92660 • (714) 644-9310
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AMERICAN ASSOCIATION OF CRITICAL-CARE NURSES
Van Hook, Jane. "The Role of the Critical Care Nurse in
Organ Donation." Presentation at the training course
for transplant coordinators in procurement. Boston,
October 1982.
Van Hook, Jane. "Gaining the Support of Neurologists,
Neurosurgeons and the Medical Examiner-Coroner."
Presentation at the training course for transplant
coordinators in procurement. Boston, October 1982.
Yokoyama Oshiro, Susan, R.N. Staff nurse in the medical
intensive care unit, UCLA Medical Center, Los Angeles,
California. Personal communication, 1983.
National Office: One Civic Plaza, Newport Beach, California 92660 • (714) 644-9310
784
BOARD OF
DIRECTORS
OFFICERS
President
Dawn Brennan
President-Elect
Mary Baker
Immediate
Past President
Nancy Sharp
Secretary
Norma Gomez
Treasurer
Marcia Keen
REGIONAL
VICE PRESIDENTS
North Central
Janet Parker
Northeast
Carol Ware
Southeast
Beth Ulrich
Western
Peggy Bruks
EXECUTIVE
COUNCIL
COMMITTEES
Awards
Gall Wick
Bylaws
Evelyn Butera
CEAB
Christine Ceccarelli
Chapters
Sally Burrows-Hudson
Clinical Practice
Susan Perras
Educational
Programming
Betty Irwin
Government
Relations
Julianne Mattimore
Kathleen Smith
Journal
Jean MacMullen
Long Range
Planning
Geraldme Biddle
Newsletter
Marie Hughes
Nominations
Jacqueline Butterbaugh
Professional
Relations
Louise Battista
May 5, 1983
Albert Gore, Jr., Chairman
Subcommittee on Investigations and Oversight
Canrtittee on Science and Technology
819 House Office Building, Annex 1
Washington, D.C. 20515
Dear Mr. Gore:
The American Association of Nephrology Nurses and Technicians
wishes to commend you on the hearings recently conducted by your
Subcommittee on the topic of transplantation. We were impressed
with the depth of knowledge you and the members of the Subcommittee
demonstrated on the subject and the level of concern exhibited for
patients around this country in need of organ transplants. All
of the issues in this very complex area were well covered during
the three days of hearings.
Nurses all around our country are intimately involved in the
care of patients awaiting transplantation and those receiving
transplants of all types. Nurses are also responsible for recog-
nizing and rendering care to potential organ donors, very often
acting as the initial contact with transplant coordinators from
local transplant programs or organ procurement agencies. In light
of this knowledge, our organization was distressed about the lack
of nursing representation on the panels presenting testimony be-
fore your Subcommittee.
Our Government Relations Committee has prepared the attached
statement for the record on the issues raised during the trans-
plantation hearings. We appreciate this opportunity to add nursing
input to the excellent testimony already before your Subcommittee.
If you have any questions or if we can be of any further
assistance to you in pursuing this topic, please do not hesitate
to contact us.
Sincerely,
A/dUhLyJ- &te**U^
Dawn T. Brennan, R.N.
President
AANNT National Office
North Woodbury Road / Box 56, Pitman, New Jersey 0807 1
Telephone: (609)589-2187
785
^ -nr
y
The American Association of Nephrology Nurses and Technicians
TESTIMONY
PRESENTED TO THE
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
APRIL 27, 1983
AANNT National Office
North Woodbury Road / Box 56, Pitman, New Jersey 08071
Telephone: (609)589-2187
786
INTRODUCTION
The American Association of Nephrology Nurses and Technicians (AANNT) is a 3500
member organization involved in the delivery of care to the nephrology patient.
Our members provide services to patients from the time they develop renal in-
sufficiency (mild kidney disease) , through the time when they are at end-stage
renal disease (ESRD) requiring some type of dialy tic therapy and transplantation.
Because of this intimate involvement with renal patients , the AANNT welcomes the
opportunity to submit its testimony to the Committee on Science and Technology.
NECESSITY FOR INCREASE IN ORGAN DONATION
Of the approximately 65,000 patients currently on some form of dialytic therapy
in this country, experts estimate that between 10 and 20% are appropriate candi-
dates for kidney transplantation. Currently there are approximately 4500 trans-
plants performed per year. One major reason for this discrepancy between the
number of transplants performed and suitable recipients is the lack of available
donor organs. Since this is true of renal transplantation about which there has
been considerable public awareness for the past twenty-five years, it is not sur-
prising to find the lack of donor organs a problem for the transplantation of
other organs.
DATA SYSTEM
Organ procurement efforts and, in fact transplantation itself, are hindered by
the lack of reliable national statistics. Unfortunately, the lack of data is
particularly obvious in the field of renal transplantation, the oldest and most
active aspect of organ transplantation. Renal transplantation is also the only
type of transplantation (except for corneal) which is government funded by the
Medicare program and yet, accurate national statistics related to the number of
donor organs, where they were procured, from what population group, how they
787
•ere used, and patient morbidity and mortality are nonexistent. In order to
.advise patients about transplanation as a mode of therapy, and to refer them to
particular centers, health care professionals need accurate comparative data
for each transplant facility derived from those national figures. Data regard-
ing transplant recipients that ©re needed are geographic and demographic charac-
teristics, graft survival rates, and patient morbidity and mortality rates.
Without such accurate data, neither we as health care professionals nor patients
seeking transplanation, nor third party payors — including the federal government—
nor the public at large will be able to make well-informed decisions. The AANNT
supports the Department of Health and Human Services recommendation that such data
collection be federally mandated as a requisite for Medicare reimbursement. Our
organization, recognizing the important role that Networks play in data collection,
support their continuation.
ORGAN PROCUREMENTS
The AANNT believes that effective organ procurement activities can best be accom-
plished through Organ Procurement Agencies (OPA' s) who would be responsible for
coordinating the harvesting, preservation, and transportation of donated organs,
and coordinating the identification of prospective recipients. In addition, public
and professional education could be planned, coordinated and executed by the OPA's.
OPA's should be formed to serve all transplant centers in a reasonable georgraphic
region. The size of the geographic regions covered by an OPA would depend on the
population, the number of transplant centers in the area, and the number of hos-
pitals and trauma centers to be served. The OPA should include a large enough
area to allow for the best use of resources and avoid duplication of services. It
should be small enough to allow for reasonable travel and frequent visitation by
coordinators to all facilities that might provide organ donors. Beyond the de-
velopment of local OPA's we encourage regional organ-sharing networks, perhaps
788
modeled after the Southeastern Organ procurement Foundation (SEOPF) and inter-
regional cooperation. We believe that such an organization would provide the
necessary structure for effective organ procurement activities without excess-
ive cost-
BRAIN DEATH POLICY
TheiAANNT supports a recommendation that the states develop statutes defining
Brain Death as a criteria for the pronouncement of death. This would facilitate
the collection of organs. Some states do not recognize Brain Death as the cessa-
tion of life.
PUBLIC EDUCATION . _ .
There is a need for a public education program to dissiminate the information that
there are thousands of people in need of organ donation. The goal of such a pub-
lic education program should be to strive to increase the public's awareness of
the need for organ donation (kidneys, livers, heart, eyes, etc.) at the time of
death (their own or family members) . The AANNT would encourage a public education
program aimed at developing a positive attitude toward organ donation. Nationally,
public consciousness could be raised by a coordinated media campaign which would
reach the general public. Increased use of public service spots — TV, radio, maga-
zines and newspapers — could increase the number of donor organs available. Costs
of these coordinated media campaigns should be shared by Medicare and third-party
payors. At present the reimbursement policies do not allow this flexibility.
Reaching the public through the education process should be part of the business
of "harvesting" donor organs. Public education costs should be uniformly recog-
nized by third-party payors. Additionally, public education programs should be
aimed at increasing awareness of the need for transplantable organs in local
hospitals, service organization, the media, schools, and colleges. Transplant
789
. aiic! transplant coordinators would do well to instill a positive attitude
toward organ donation in students in high schools and colleges. The AANNT supports
the continued use of organ donor cards and consent for organ donation on drivers'
licenses. This points up again the need for public education so that firstcon-
tact personnel with a potential organ donor will be alert to the victim's wishes
and make the appropriate personnel aware of this.
PROFESSIONAL EDUCATION
The AANNT encourages education aimed at developing counselling skills on organ
donation and transplantation in the medical profession itself. Medical schools
and nursing schools should devote energy to educating their students to work with
families and relations of suitable donors. This could be a condition of govern-
ment funding for these institutions and programs.
PRESUMED CONSENT
The AANNT believes that this concept as presented at the Oversight Hearings may
have merit in the future; however, the potential for generating negative senti-
ment about organ donation in the population as a whole should be anticipated and
prevented. Therefore, the AANNT supports a study of public attitude in this area
prior to moving in this direction.
RESEARCH
The AANNT joins the NIH and other organizations who support the funding of in-
creased and continued research in the field of immunology. As noted by others,
more data are needed in the use of Cyclosporin-A, the refinement of tissue-typing
techniques, donor specific transfusions and the area or organ preservation.
EMERGENCY DEPARTMENT RESPONSIBILITY
It is the position of the AANNT that each hospital emergency department be re-
quired (as a condition of reimbursement from Medicare/Medicaid and/or as JCHA
requirement for accreditation) to document on intake whether a patient is considered
23-029 0 - 83 - 50
790
to be a potential organ donor candidate and fuLr' r to document a;:: ropriate
followup when the patient is so designate 3.
NATCO
The AANNT wholeheartedly supports the suggestions by the North American Trans-
plant Coordinators Organization, in particular, the suggestion that a national
organ donation awareness week be identified annually and that . jcal representa-
tives publicly sign donor cards in their home districts to enhance their constitu-
ents'awareness of the need for more organ donors around the country.
CONCLUSION
The AANNT strongly support the growth and development of transplantation of organs
as a viable therapy for some patients. It is hoped that the disparity between
the supply and demand will be narrowed. Our representatives stand ready to answer
any questions.
791
rsMPHr
NATIONAL ASSOCIATION OF PATIENTS ON
HEMODIALYSIS ANDTRANSPLANTATION. INC.
1 56 William St., New York, N.Y. 10038
(212)619-2727
April 25, 1983
Honorary Chairman
CONGRESSMAN CHARLES B RANGEL
Officers
JOHN NEWMANN. PhD.MPH,
President
PAULL FEINSMITH
First Vice-President
SHIRLEY S BIER
RAYMOND F BOUDOIN
Vice-Presidents
PATRICIA HERLINGER
Secretary
MARTHA ORR
Assistant Secretary
KENNETH KOLATOR
Treasurer
LAWRENCE Z FALTER
Assistant Treasurer
Stall
MARGARET DIENER M P H
Executive Director
MAUREEN LUNDIN
Editor. NAPHT NEWS
Medical Advisor
ELI A FRIEDMAN. MD
Professor ot Medicine
Director of Dialysis Units
State University ot New York
Downstate Medical Center
Medical Advisory Board
CHRISTOPHER R BLAGG. M D
Director
Norlhwesl Kidney Center
KHALID BUTT. M D
Director of Transplantation
State University of New York
Downstate Medical Center
IRAGREIFER, MD
Director of Pediatrics and
Children's Kidney Center
The Hospital of Albert Einstein
College ot Medicine
MALCOLM A HOLLIDAY. M D
Professor of Pediatrics
University of California
San Francisco General Hospital
WILLEM J KOLFF. M D
Head, Division ot Artificial Organs
University ot Utah
JOHN P MERRILL, M D
Director. Cardiorenal Section
Peter Bent Bngham Hospital
GEORGE E SCHREINER. M D
Professor ot Medicine
Georgetown University School
School of Medicine
BELDING H SCRIBNER, M D
Professor of Medicine
University ot Washington
GERALD THOMSON. M D
Professor of Medicine
Harlem Hospital
The Honorable Albert Gore, Jr.
Chairman
Subcommittee on Investigation and Oversight
Committee on Science and Technology
House of Representatives
Washington, D.C. 20515
Dear Congressman Gore:
On behalf of the National Association of Patients
on Hemodialysis and Transplantation, I would like
to thank you for your interest in organ
transplantation and congratulate you for holding
hearings on this important and timely topic.
Our Association has a membership of over 10,000
individuals with irreversible kidney failure from
all states and U.S. territories. Obviously, the
topic of transplantation is of great interest and
concern to our members, and I would like to offer
some comments for your consideration.
Before beginning, I would like to point out that
as an organization we do not endorse any one
therapy over other available therapies but believe
that all patients should have the full range of
options available to them. Currently, of course,
those with kidney failure can be treated by
dialysis (in several forms) as well as by a kidney
transplant. Neither therapy is perfect and both
have some disadvantages. Thus, some patients,
myself included, have chosen not to have a
transplant at the present time. However, we all
are waiting and watching for continued medical
advances which will make transplantation of
kidneys more successful and see it as the ultimate
solution to our medical problem.
As you are aware, the number of kidney transplants
per year in this country are between 4,000 and
5,000. There are a number of reasons why more
transplants are not done, and I want to share some
of those reasons expressed by our members:
1. As I already indicated, transplantation is not
yet a perfect therapy. Some patients have simply
chosen to stay with dialysis until the success
rate improves further.
A NON PROFIT ORGANIZATION
792
2. There are insufficient cadaveric kidneys available at
this time. Not all states have adopted "brain death"
legislation, and inclusion of uniform donor cards on
drivers' licenses is far from universal. Both of these
measures are needed to increase the supply of organs along
with further public and medical professional education.
3. We have been surprised to learn that some transplant
institutions will not include a patient on their waiting
list for an organ if that person in on a list at another
unit. For someone awaiting a transplant, this is a most
frustrating circumstance.
4. There are financial disincentives for patients even
though Medicare pays for much of the cost of the surgery.
For living-related donation, there are often substantial
travel and living costs in connection with the procedure.
For all transplant candidates who are not physically near a
transplant center, travel costs can be prohibitive for both
the patient and the family.
5. Kidney patients are usually quite sophisticated about
medical procedures and want to have a transplant done at the
facility which has been most successful with this procedure.
Information about facility-specific success rates is very
difficult for patients to obtain but is greatly desired by
them.
6. Medicare coverage ends 36 months after a successful
transplant, but obtaining other health insurance is
extremely difficult. Medical bills (e.g. repeated checkups,
daily medications), even for a person with a successful
transplant, are often substantial and inability to get any
insurance coverage is a major problem. This has served as a
disincentive in two ways. In the first instance, some
people have indicated that this inhibits choosing a
transplant. An even greater problem is that those
individuals who have had a successful tranplant often seek
to stay on the disability rolls to insure continued Medicare
coverage. They also often find that employers are hesitant
to hire them because of increases in insurance premiums
which may result from frequent claims against the policy.
We welcome efforts by the Science and Technology Committee
to remove barriers to transplantation and to encourage organ
donation. We urge you to consider the following
recommendations for action:
793
1. institutions currently certified by Medicare to perform
transplants should be prohibited from refusing to include
patients on their waiting lists who are on other lists.
Further such institutions should be required to publish, on
a yearly basis, their success rates with both living-related
and cadaveric transplants on both a short term (one year)
and long term basis (five or ten years).
2. Medicare coverage should continue indefinitely for
recipients of kidney transplants. We do not believe that
this would increase the cost to the ESRD program in any
significant amount and would undoubtedly serve to decrease
funds spent by the disability program.
3. We urge that liver transplantation no longer be classed
as an experimental procedure so that Medicare and Medicaid
funding be available to pay the costs of this expensive but
life-giving therapy. Many of our members have experienced
the frustration of facing death and/or financial ruin
because of failing kidneys. The extension of Medicare
coverage to those with kidney failure in 1973 has saved
countless lives, and we have the deepest sympathy for those
with liver failure who must have a transplant to survive.
4. We ask that the federal government use its good offices
to encourage changes in state laws to establish a uniform
definition of death and to make uniform organ donor cards
more widely available.
5. We urge continued support for research into the causes
of kidney and other organ failure as well as research to
improve the technical success of transplantation with a
minimization of side effects.
Again, I thank you for your interest in this topic and I
would be happy to provide any further information.
Sincerely,
Newmann, Ph.D., M.P.H.
President
794
<s>
Medic Alert Foundation
International
Phone 209/668-3333
Turlock, California 95380
TWX 510 766 3302 A/B MAPI TLK
FOUNDER AND HONORARY
CHAIRMAN 1956-1977
Marlon C. Collins. M.D.
GENERAL SECRETARY
Mrs. Marlon C. Collins
PRESIDENT
Alfred A. Hodder
DIRECTOR OF
MEDICAL AFFAIRS
Luther L. Terry, M.D.
DIRECTOR OF
PROFESSIONAL RELATIONS
George M Wheatley, M.D.
BOARD OF DIRECTORS
CHAIRMAN
Douglass S. Thompson. M.D.'
VICE-CHAIRMAN
Richard S. Wilbur, M.D.-
SECRETARY
George J. Sledel, J.D.-
TREASURER
Lee E. Schwartz, C.P.A.*
Mary Cockayne
Mrs. Marlon C. Collins'
Darrell Elchhoff
C. Robinson Fish III. C.L.U.
Whll Hobbs
Alfred A. Hodder
James T. Howell. M.D.
Everett H. Johnson, M.D.
John I. Maurer, M.D.
George Podgorny. M.D
Maria Prado. A.R.N.P
Chief William F. Oulnn
Maureen H. Roberts. M.D.
William T. Robinson"
George J. Sledel, J.D.'
Luther L. Terry. M.D.
Malcolm C. Todd. M.D.
Reverend George
Twlgg-Porter, S.J.. M.A.
Grace Ulbrlcht
Percy Wood
'Executive commit!*
April 13, 1983
Honorable Albert Gore, Jr.
Chairman
U.S. House of Representatives
Subcommitee on Investigations and Oversight
of the Committee on Science, and Technology
Room 822 - Annex Building 1
Washington, D.C. 20515
Dear Mr. Gore:
At the invitation of the staff of your
Subcommittee on Investigations and Oversight, I
am submitting the attached Statement in behalf of
the Medic Alert Foundation International for
inclusion in the record of the hearings on organ
transplantation scheduled for April 13-14, 1983.
The purpose is this Statement is to make
known to the Congress, through your Subcommittee's
examination of the foregoing issue, the national
resources which our Foundation currently provides,
and those it is planning for the future, as a
nationally recognized computer-based personal
medical emergency information system. Specifically,
it points out how that system can be utilized to
identify donors of live human organs, advise those
physicians and Institutions with waiting potential
transplant recipients, and help process that activity.
As indicated, this is a Statement offered by
three senior Foundation officials: Douglass S.
Thompson, M.D. , Chairman of its Board of
Directors, James T. Howell, M.D. , also a member of
the Board who Is working with its Special Task
Force on Information and Communications
Technology, and George M. Wheateley, M.D. , also a
members of that Task Force as the Foundation's
Director of Professional Relations. Any one or
all of these physicians is available to provide
you, or members of your staff, with any additional
information that might be required.
rcred A. Hodder
President
A Charitable, Tax-Exempt. Nonprofit Foundation
795
*STATEMENT- PRESENTED BY THE MEDIC ALERT FOUNDATION INTERNATIONAL
OF TURLOCK, CALIFORNIA REGARDING THE POTENTIAL ROLE
OF ITS PERSONAL MEDICAL EMERGENCY INFORMATION SYSTEM
TO ASSIST IN THE DEVELOPMENT OF A HUMAN ORGAN
TRANSPLANTATION REGISTRATION AND INFORMATION PROGRAM
This STATEMENT is presented by the Medic Alert Foundation
International in the hope that it will be helpful to the Subcommittee in
expanding its understanding of a critical aspect of organ transplantation
- - - that of the timely and accurate identification and clearance of
prospective donors, and expiditing the process of providing such organs to
those waiting for transplants. This information is offered for whatever
help it may be in the Subcommittee's consideration of the development of
public policy, and possible legislation designed to solve some of the
important socio-economic and scientific problems involved with what has
become a significant life-saving medical development.
The Medic Alert Foundation is a voluntary not-for-profit
organization which - - - since it was founded in 1956 - - -
has provided a personal emergency medical information
system to serve those individuals who have special medical
conditions, or other health factors, which must be
immediately made known to physicians and other medical
professionals called upon to treat them in the event of a
medical emergency.
. Within that system, that basic information is carried on a
specially designed and internationally recognized Medic
Alert bracelet or necklace, and is amplified on a wallet
card carried by all subscriber-members. All of that data,
and more, is also stored in the the computers based at the
Foundation's headquarters in Turlock California, where it
is available on a 24-hour-a-day basis to physicians and
authorized emergency medical personnel, institutions and
services anywhere in the continental United States, or any
other part of the world.
Currently, there are more than 2 million subscriber-members
who avail themselves of these Medic Alert services,
including employees of many companies who offer this
coverage as a health and medical benefit.
In its 27 years of operation, the Medic Alert Foundation
and the system it operates has become a recognized world-
wide organization; the internationally accepted standard
for providing this very special type of protection to its
subscriber-members; and acknowledged by the medical
profession for providing accurate and timely service.
*Submitted to U.S. House of Representatives Subcommittee on Investigations
and Oversight of the Committee on Science and Technology in connection
with its hearings on organ transplantation, April 13-14, 1983.
796
STATEMENT - 2 -
As such, the Medic Alert Foundation is in a position to
help address one of the principle problems in implementing
live human organ transplantation programs - - - the timely
and accurate identification and clearance of prospective
donors - - - today and in the future. Ultimately, it might
even manage and expidite the process of matching such
organs to those waiting for transplants.
Not only could the current Medic Alert symbol and system
help meet an immediate need to register and identify more
organ donors, but plans now under development by the
Special Task Force on Information and Communications
Technology of the Foundation' s Long Range Planning
Committee, are ideally suited to include what would be
needed by such an organ transplantation registration and
identification program of the future.
The process of the timely and accurate identification and
clearance of prospective organ donors is relatively
uncomplicated in the case of immediately available
volunteers. However, it becomes exceptionally complicated
when it involves those individuals who have expressed their
wish to be organ donors, but, by virtue of unpredicitible
circumstances, may be expiring in an emergency unit as the
result of a tragic accident.
In addition, for the medical profession to be able to
identify such individuals as organ donors; make known the
availability of such organs to those who need to know;
salvage those viable organs by precise surgical techniques;
gain such permission as may be needed to perform those
necessary procedures to extract and transfer human living
tissue; and insure proper care and the immediate delivery
of those organs to the proper destination, require
complicated, demanding and exacting procedures.
Many Medic Alert subscriber-members and others have already
registered themselves in a variety of ways to indicate
their wish to be organ donors. They can be identified, as
such, on their Medic Alert bracelets and wallet cards, and
by other identification including their drivers' liscenses
from some states. What is needed immediately and in the
future, however, is an established symbol, standard, system
and network within which such potential donors can be
registered, and immediately identified as organ donors.
797
STATEMENT - 3 -
We submit that a recognized and standardized system would
offer the protocol by which physicians, and other emergency
medical personnel treating accident cases in emergency
units, can be alerted that organ donations are intended,
and may be performed. Within the context of that same
system, they would also be able to utilize its network to
advise those who are waiting for the availabiliaty of such
organs to be prepared to receive them for implantation.
As planned, the Medic Alert service of the future will not
only continue to employ its internationally recognized
symbol and bracelet, but will become a fully electronic
computer-based personal emergency medical information
system. As such, it will utilize all of the new
technologies of microprocessing to encode, store, update
and trasmit health and medical data suitable to such a
system. In that way, it will afford all Medic Alert
subscriber-members the opportunity to have the basic
elements of their own medical record abstract immediately
available including their wish to be an organ donor
by carrying that information on their own person.
In plans already under development, this would be achieved
by having such information contained in a silicon chip
embedded in the bracelet, or on a magnetic strip included
on the wallet card. Either could be read at the scene of
an accident or in a hospital or other emergency facility,
by utilizing simple electronic readers. Additional
information could also be called up from the Foundation-
based computers on electronic terminals.
In essence, the Medic Alert Foundation and system, as they
exist today, can provide direct and immediate assistance in
registering and identifying an ever- increasing number of
organ donors. Plans for the future, on the other hand,
have the potential for including a fully computerized
registration and information system for a human organ
transplantation program. Therefore, it would seem
appropriate that the latter program be developed by the
Medic Alert Foundation in conjunction with a cooperative
effort among those agencies and organizations directly
concnerned with the problems of transplantation.
798
STATEMENT - 4 -
We appreciate the opportunity to submit the foregoing information and
ideas to this Subcommittee. We trust that what we have presented will be
helpful in the work of developing the most effective and productive organ
transplantation program possible.
In that regard, we would note that the Medic Alert Foundation stands
ready to cooperate in any way it can toward the achievement of such a goal.
Therefore, we would welcome the opportunity to explain and further detail
our current personal emergency medical information system, and what is being
planned for that system in the future. As indicated, that latter work is
already underway, and documentation of it is available.
MEDIC ALERT FOUNDATION INTERNATIONAL
Douglass S. Thompson, M.D
Chairman, Board of Directors
Clinical Professor of Obstretics and Gynecology
University of Pittsburgh Medical School
Pittsburgh, Pennsylvania
James T. Howell, M.D.
Member, Board of Directors and
Long Range Planning Committee
Director of Long Range Planning
Georegetown University Medical Center
Washington, D.C.
George M. Wheatley, M.D.
Director of Professional Relations
Medical Director
Sugffolk County Department of Social Services
Hauppauge, Long Island, N.Y.
April 13, 1983
ESRD
NETWORK 23
799
End Stage Renal Disease Network of the Greater Capital Area, Inc.
4701 Willard Avenue Suite 610 Chevy Chase, Maryland 20815
(301) 652-0067
April 11, 1983
Honorable albert Gore, Jr. , Chairman
Subcommittee on Investigations and Oversight
Conmittee on Science and Technology
U.S. House of Representatives
House Annex #1, Hxm 822
Washington, D.C.
Dear Chairman Gore:
1 am prompted to write this letter to you because I have come to learn of
your Subcommittee's planned hearings this month on the subject of human
organ transplants. Please make this communication a part of the official
record of the hearing.
I personally am a renal transplant patient of five years and prior to that
was a home hemodialysis patient for five years. I write this letter as
Chairperson of the Patient Action Committee of The End Stage Benal Disease
Network #23. This Committee includes patients in all modalities of kidney
care (hemodialysis-both in center and home, continuous ambulatory peritoneal
dialysis, and transplantation) . Network #23 represents the National Capital
Area — the District of Columbia, Northern Virginia, and surrounding Maryland
counties.
We wish to make the point that Medicare needs to be changed somewhat. The
cut-off of Medicare benefits at 36 months after transplantation needs to be
extended for the life of the kidney, and Medicare should cover some of the
medications that transplanted kidney patients must take, at least those
iimunb-suppressive drugs that are common to all transplanted patients.
I am taking the liberty of sending with this letter a copy of a paper which
my Conmittee authored on this subject in 1981 and which I entered as evidence
when I testified before the Senate Finance Conmittee that same year in a
hearing similar to those you will be holding. While the numbers in this
paper are obviously a little stale, the message and principles involved are
still cogent.
800
Letter to Honorable Albert Gore, Jr. , Chairman
April 11, 1983
Page 2
We are prompted to raise this issue again for a couple of reasons. The
current 36-manth cut-off of Medicare coverage for transplanted kidney
patients is arbitrary. It must be remembered that a kidney transplant is
not a total cure (like an appendectomy) , but it is just another modality
for treating the diseased condition and the maintenance costs continue.
Lastly, we understand that new immuno-suppressive drugs will soon be on the
market and available (e.g. cyclosporin A) that are reputed to be able to
elevate significantly the degree of success in organ transplantation. This,
of course, would apply not only to kidneys, but to all other human organs
that can be transplanted (liver, heart, etc.) . Peports we have heard indicate
that the success rate can be increased through the use of cyclosporin A from
the current 50 percent to 85 percent. Further, some unwanted side effects
will be drastically reduced, we are told.
However, cyclosporin A, while being ascribed these wonderful attributes, is
also reported to be very expensive; we have heard reports that it could
amount to $5,000 per year per patient. If all this is true, the mere avail-
ability of the newest drug (which patients would want, if they could have
it) could present still a further financial disincentive to transplantation.
In summary, it seems to us as though the Medicare changes we recommended in
1981 (i.e. , removing the current 36-month barrier and allowing routine
medications be covered) still need to be considered by the Congress.
Sincerely yours,
Ernest T. Bauer
Chairperson
Patient Action Committee
ESRD Network #23
Enclosure
801
REMOVING THE CURRENT 36-MONTH BARRIER TO CONTINUATION OF
MEDICARE INSURANCE COVERAGE AFTER A KIDNEY TRANSPLANT
Background
Medicare, through Social Security Act Amendments, now covers 80%
of the medical costs for End Stage Renal Disease patients up until 36 months
after kidney transplant. This provision in the law covers 80% of the costs
for hemodialysis, continuous ambulatory peritoneal dialysis and surgery for
kidney transplantation, as well as the routine medical maintenance and hospital
visits that are required subsequent to kidney transplant. This cut-off
of Medicare benefits at the 36-month point is contained in P.L. 95-292
dated June 19, 1978. The specific reference is in Section 226 A,b,2 and
reads as follows:
Entitlement "shall end, in the case of an individual who receives
a kidney transplant with the thirty-sixth month after the month in
which such individual received such transplant, or in the case of
an individual who has not received a kidney transplant and no longer
requires a regular course of dialysis, with the twelth month after
the month in which such course of dialysis is terminated."
Recommendation
The Patient Advisory Committee of End Stage Renal Disease Network
#23 (which includes the District of Columbia, Northern Virginia, and
the Southern Maryland) submits that this provision in the law which ends
Medicare coverage at the 36-month point is inequitable and constitutes
potentially a financial disincentive for many peole to receive a kidney
transplant. We recommend that Medicare coverage be extended from the
current 36-month statutory limit to the life of trie kidney.
802
Page 2
Rationale
With Medicare and the Social Security Program already having invested
vast amounts in many renal patients by way of years on dialysis and perhaps
the cost of a kidney transplantation (or several), it makes little sense for
Medicare to cease payments after 36 months because this tends only to denigrate
the large investment which Medicare already has in these patients. Also,
many patients with a transplanted kidney might not be able to bear the burden
of the financial cost of medical maintenance on their own and would thus be
inclined to take poorer care of themselves. Considering the large investment
already made by Medicare in patients with a transplanted kidney, proper and
adequate medical care should be almost as much a concern of Medicare as it is
of the individual patient himself.
The philosophy of the federal Medicare program is to promote better and
cheaper modalities for treating end stage renal disease. In the typical
case (and assuming these options are medically possible), a patient is
encouraged to dialyze at home (as opposed to in center dialysis) and
ultimately to receive a kidney transplant. The Patient Advisory Committee
of ESRD Network #23 suggests that this 36-month barrier articulated
in P.L. 95-292 tends also to militate against this basic philosophy of
Medicare.
We do not dismiss the important fact that expenses involved in all forms
of treatment for kidney disease and its multiple related complications are
prohibitive. At present, Medicare coverage is provided for 80% of the cost
of dialysis and its related maintenance. Some patients have been treated
by some form of dialysis since it became available. Improvements in tech-
nology and better knowledge of kidney disease promise these patients an
ever-increasing lifespan. For many, it is the best, or only acceptable, form
803
Page 3
of treatment. We do not challenge their right of choice in mode of treat-
ment.
There is a need, however, to establish an equity among all modes of
treatment. The person with a kidney transplant is covered in the same
manner as the dialysis patient for 36 months following a successful kidney
transplant. At that time his coverage is terminated, but his expenses are
not. We propose the extension of Medicare coverage to include the life of
the kidney.
The initial first year expenses for a kidney transplant exceed those of
the maintenance costs for the same time period with a form of dialysis.
Following the first year of transplantation, however, these costs drop
dramatically. But, they remain beyond the financial reach of many individuals.
There are frequent lab services, expensive medication, and the preventive care
so important to the transplant recipient who has his immune system suppressed.
The body seeks to protect itself from the invasion of foreign matter, i.e.
the kidney.
Protecting the kidney from rejection in this manner requires drug therapy.
In turn, the body is vulnerable to other infections and diseases, requiring
the patient to practice careful preventive medicine. Lab tests keep a check
on the status of the kidney and anticipate potential problems. And there are
complications. Among others, these include cataracts, lowered resistance, and
bone demineral ization that may require hip replacement.
In spite of these problems, a kidney transplant represents the best hope
of reintegrating the person with end stage renal disease back into a more
normal life. Physicians have said that while a machine may be able to
maintain life, it can never equal the benefits obtained from a working organ.
Loss of the kidney necessitates a return to a form of chronic treatment on
dialysis.
804
Page 4
The present termination of medical coverage for a kidney transplant
after 36 months is a disincentive to the patient considering transplanta-
tion. Employers are reluctant to provide insurance coverage to a renal
patient. Those patients who have entered the end stage renal disease
program through disability are reluctant to reenter the job market and
risk the loss of their entitlement to Medicare. While not able to handle
full recovery status or return to their original type of employment, some
transplant recipients could handle some form of partial recovery. They
cannot, however, afford to lose their Medicare coverage. The government has
a substantial investment in the person with kidney disease. It needs to
encourage transplantation as an attractive alternative, whenever medically
and emotionally feasible. The government needs to provide the security
of continued Medicare coverage so that the transplant recipient has the
confidence to attempt to return to some manner of self-reliance without
fear of loss of vitally needed medical coverage.
Kidney Transplant Statistics
Since 1973, when Medicare first began to cover the costs of end stage
renal disease, kidney transplants have been on the rise. The following
table, which has been prepared from statistics secured from the U.S.
Department of Health and Human Services presents the latest information
that is available on kidney transplants for the Nation as a whole:
805
Page 5
CALENDAR YEAR
TOTAL TRANSPLANTS
LIVING RELATED
CADAVERIC
1973
1,500
Unknown
Unknown
1974
3,179
Unknown
Unknown
1975
3,730
Unknown
Unknown
1976
3,175
911
2,264
1977
3,973
1,495
2,478
1978
3,949
1,172
2,777
1979
4,271
1,205
3,066
1980
4,630
1,270
3,360
While these statistics are impressive and show that surgical kidney
transplants have risen dramatically in eight years (and in this time
over 28,000 ESRD patients have been taken off the highly expensive dialysis
regimen at least for a time), they do not indicate the number of persons
living today in the United States with a successfully transplanted kidney.
Those particular data for the nation as a whole are not available.
Because of this gap in the current data colection system, we have tried instead
to present as best we can the picture on the successful living kidney
transplant population as we know it exists in Network #23 and then extrapolate
that figure to approximate the nationwide statistic.
To present a comparable table on transplant activities for the
metropolitan Washington, D. C. area and environs, the table below depicts
comparable kidney transplant activity between the years 1977 and 1980
(the only years for which information is available) for ESRD Network #23:
23-029 0-83-51
806
Page 6
CALENDAR YEAR
TOTAL TRANSPLANTS
LIVING RELATED
CADAVERIC
1977
95
45
50
1978
62
21
41
1979
79
28
51
1980
93
26
67
In these four years, there were 329 kidney transplants performed and,
as of December 31, 1980, there were 149 of these patients who have a successful,
still-living transplanted kidney. Of this 149 total, 51 (34%) have had
their transplants more than 36 months and are, therefore, patients who would
benefit by the legislative change we are recommending.
In an attempt to extrapolate the experience in Network #23 and apply that
to the nation as a whole, we find that approximately 25% of all transplanted
patients and their kidneys survive beyond the 36 month period. Utilizing
the total number of transplants as listed in the first table above, there were
performed since 1973 in this country a total of 28,407 kidney transplants.
Assuming that 25% of those kidneys will still be functioning 36 months after
the transplant (i.e. the Washington experience) , that would leave a total
for the nation as a whole of 9,658 kidney transplants still functioning.
Thus, there are, as best we can guess, about 9,700 patients living in this
country with transplanted kidneys beyond the 36 month period, where Medicare
would be picking up 80% of their expenses for routine medical maintenance
and hospital visits.
Estimated Costs
The average kidney patient must report back to his renal transplant center
(hospital) for extensive blood tests, urinalyses, and other medical checks, in-
cluding a doctor's examination on the average of once a month. For patients who
have no other medical complication, the cost of these monthly maintenance visits
807
Page 7
approximates $300-$600. On that basis, and merely extending the figures,
the total cost for removing this 36 month barrier after transplant for current
kidney patients would run somewhere in the magnitude of $28-$56 million per
year (i.e. $300 X 12 [months X 9700 [patients X 80%). This amount can be
compared to the cost of these patients remaining on hemodialysis for a year.
The amount would be approximately $192,758,400.00 ($138 X 12 [treatments
per month X 12 [months X 9,708 [patients . Thus, by these patients being
and remaining transplanted, an estimated $136,758,400.00 to $164,758,400.00
per year would theoretically be saved.
As a secondary issue, the patient population would also advocate having
the cost of monthly medications also covered by the Medicare insurance program.
These routine medications for most kidney transplant patients run in the
magnitude of $100- $200 for routine anti-rejection medications (such as imuran
and prednizone). These costs are not now covered. Extending the same then
arithmetic (i.e. $100 X 12 X 9700 X 80%), medications could cost an additional
$9.0 to $19.0 million per year.
Patients on dialysis, however, have some of their medications covered by
Medicare - albumin, inferon, decaducolium, antibiotics given intravenously or
intermuscularly, and most emergency drugs.
For some transplant patients, their secondary insurance coverage will
reimburse them for these medication costs, but not all renal transplant
patients have a secondary carrier because they can't afford one or are not
employed in a situation where such medical insurance is part of the normal
benefits package.
In summary, the end stage renal disease patient population recommends
that the current barrier which calls for Medicare insurance coverage to cease
after 36 month after transplant be eliminated. Medical costs continue at a
modest level for many of these patients beyond the 36 month period and our
recommendation is that the insurance coverage be extended for the life of the
808
Page
kidney. The second point we would make is that Medicare coverage be extended
to cover also the cost of routine medications which must be taken by patients
with transplanted kidneys and which costs are currently excluded from
excluded from payment by Medicare. Such changes, it seems to us, can be made
by deleting and adding the appropriate language to Public Law 95-292.
These legislative recommendations, while offered by ESRD Network #23,
are also supported by other ESRD Networks around the country, as well as
by the National Association of Patients on Hemodialysis and Transplantation
and the American Society of Transplant Surgeons.
It must be stressed that we view these proposals as being not so
much a further extension of a program, which we are fully aware is costing
much more than the Congress and the Administration ever dreamed it would
cost in the first instance, but rather an attempt to make more equitable
the treatment of patients. Thus, our argument is one of equity; the
extra costs involved are relatively minor compared to the total cost of
the program and to what the costs would be if they remained on dialysis.
809
22 April 1983
Honorable Albert Gore, Jr., Chairman
Subcommittee on Investigations and Oversight
Committee on Science and Technology
U. S. House of Representatives
House Annex # 1, Room 822
Washington, D. C. 20515
Dear Chairman Gore:
Congratulations on your decision to tackle the gargantuan
issues pertaining to organ transplantation. I would like
to submit for your consideration the following observations
and attached copies of reports which I feel are pertinent
to the subject of organ transplantation. Please place
this letter and the enclosures in the official record.
I feel well qualified to comment on some of the issues
faced by your committee. My disposition and educational
background are those of an activist. Much of my energy
is focused on the concerns of the renal patient. And of
most importance - I have a personal commitment. I received
a kidney transplant in early March 1977. Prior to that,
I spent two years as a hemo and peritoneal dialysis patient.
My own kidneys began to fail in January of 1971 following
a complicated still-birth pregnancy. In those early years,
i/became well-versed on what was then an infant technology.
I watched anxiously as it developed, knowing its paramount
importance to me. How far we have come.' It is recognized
now that the transplantation of kidneys is a viable
alternative and we have progressed to a second phase that
has turned its attention to finding the best means of
improving the quality of life for a person with renal
disease.
I am a member of ESRD NETWORK 23 Patient Action Committee
(representing The Washington Metropolitan Area of The
District of Columbia, Northern Virginia, and suburban
Maryland), specializing in legislative issues. Our committee
has written a paper (see attached copy) advocating the
extension of medicare coverage following a kidney transplant
to the 'life of the kidney'. The paper also endorses the
expansion of medicare coverage to include medications which
are used to treat the transplant patient.
810
At the present time, medicare coverage for the renal
patient is inequitable. A kidney transplant is only one
of several modalities for the treatment of renal disease
and should not be regarded as a cure. Successful treatment
requires a life-time commitment to special medication and
health care maintenance. A kidney transplant is not
without complications. Most of these are attributed to
the current types of medication required. There is hope
that the new drugs that are emerging, while very expensive,
will eliminate or at least dramatically decrease these
drug related complications. The technology of dialysis
has also improved, making this modality also possible for
long-term treatment. The equipment, supplies, and compli-
cations associated with dialysis are fully covered for the
'life of the modality'. The termination of medicare
coverage 36 months after a kidney transplant is discriminatory.
In 1982 I was a member of The National Rehabilitation
Task Force to End Stage Renal Disease Programs, serving
on the subcommittee studying financial incentives (see
attached copy of final report). The Task Force explored
several areas affecting rehabilitation of the renal patient,
touching on all modalities including that of kidney trans-
plants. The points raised by The Task Force are applicable
to all organ transplant programs and relevant to your
current investigation.
The cost to maintain a successful kidney transplant is
beyond the financial ability of the average person. It
is difficult to maintain medical insurance and next to
impossible to regain such insurance upon return to the
work force. Lack of medical insurance may force the
kidney transplant to forgo needed treatment and jeopardize
the continued success of the transplant. Loss of the
transplanted kidney results in a return to dialysis. Or,
the prospect of inability to meet the financial require-
ments of a kidney transplant could be a negative factor
in the consideration of which modality to choose. This
decision should be based purely on medical considerations.
Regulations governing disability eligibility have no
provision for a partial disability classification. Faced
with the lpss of medical coverage, prohibitive medical
costs, and^unable to make a full time return to the work
force discourages any attempt to relinquish a disability
classification. Changes need to be made to provide for
the person who is able to return toja partial income earning
status and at the same time insure the security of continued
medical coverage.
811
In conjunction with the discussion found in the attached
reports, I urge the committee to address^
(1) The extension of medicare coverage following
a kidney transplant to the 'life of the kidney .
The expansion of medicare coverage to those
medications necessary for maintenance of a
successful organ transplant.
(2) Changes in the present disability regulations
to allow for varying degrees of disability.
The findings of The Task Force and the position paper
produced by ESRD NETWORK 23 PAC complement each other.
Both express concern for developing the best means of
reintegrating the person with renal disease mto_ a_ lit e-
style that is personally productive while recognizing the
realities associated with a catastrophic illness. The
transplanting of kidneys was a pioneer in the field of
organ transplantation. Other developing organ transplan-
tation programs can benefit from a study of the growing
pains experienced in the field of kidney transplantation.
Thank you for allowing me access to this forum. I hope
that my comments will prove useful to your investigation.
Two Enclosures
812
ARMITAGE & FARNUM
ATTORNEYS AT LAW
SUITE 1040
OZARK NATIONAL LIFE BLDG.
RICHARD E. ARMITAGE 906 GRAND
THOMAS H. FARNUM KANSAS CITY. MISSOURI 641 06
816-421 5002
April 12, 1983
The Hon. Albert Gore, Jr.
Chairman, Sub-Committee on
Investigations & Oversight
Committee on Science & Technology
United States House of Representatives
Room 822, House Annex #1
Washington, D.C. 20515
Re: Sub-Committee Hearings on Organ Procurement
Dear Congressman Gore:
I am writing on behalf of the Midwest Organ Bank, Inc.,
(hereinafter referred to as MOB) , a non-profit organ procurement
agency and histo-compatibility laboratory located in Kansas City,
Missouri. Because of the MOB ' s long-standing interest and con-
cerns pertaining to the federal government's role in the End-Stage
Renal Disease Program, both from a fiscal and a program standpoint,
the MOB desires to make its views known to the Sub-committee in
light of the forthcoming hearings on organ procurement. There-
fore, we respectfully request that this letter and the enclosed
documents be attached to and made a part of the record of those
hearings scheduled for April 13, 14, and 27th, 1983.
The focal point of the MOB's concerns in the past and at the
present is the impact of the current regulations affecting reimburse-
ment to OPA's and histo-labs as a result of Public Law 95-292 passed
by Congress in 1978. Because of those concerns, we prepared a
Position Paper in the summer of 1980 which was submitted to the Sub-
committee on Health of the House of Ways and Means Committee, and
the Sub-committee on Health of the Senate Finance Committee. In
1980 and 1981, we spent considerable time talking with various
congressmen and senators in the Missouri and Kansas region about
these concerns and whether or not the reimbursement regulations
could have a stagnating effect on transplantation in this country.
You will find enclosed a copy of that Position Paper which outlines
in some detail those areas which we felt needed to be reviewed in
light of the regulatory scheme promulgated by the Health Care Finan-
cing Administration. You will also find enclosed a memorandum which
813
is basically a summary of the Position Paper and is useful as a
guide for analyzing any of those areas. We believe both documents
are self-explanatory and speak for themselves, and we are hopeful
that they will assist you in some way as you look into the total
organ procurement program as it currently exists.
Also in relation to the fiscal aspect of reimbursement to
OPA's and histo-labs, we are greatly concerned as to the impact of
the new prospective reimbursement provisions of the Medicare Reform
Act recently passed by Congress. More specifically, we understand
that HCFA is currently studying proposed regulations to determine
whether or not those funds reimbursed for tissue-typing and kidney
acquisition shall be included in the kidney transplant DRG. We
would like to go on record opposing the inclusion of such costs
within the DRG since the rates for kidney acquisition and for
tissue-typing vary distinctly from OPA to OPA and histo-lab to
histo-lab It is our position that those costs should be directly
reimbursed outside the DRG formula. Otherwise, to include those
costs within the allotted DRG amount would undoubtedly put the
brakes on the future of transplantation as a viable medical therapy.
My review and interpretation of the new statute indicates that Con-
gress did not intend to mandate that organ retrieval and tissue-
typing costs be included within the DRG formula.
We would also like to briefly address those issues which will
be raised at the hearings on April 13 and 14 pertaining to problems
within the organ procurement system, and specifically those areas
of inquiry reflecting possible changes in the structure of the
retrieval program. As to the area of inquiry pertaining to the
Uniform Anatomical Gift Act, it is our opinion that the Act is cer-
tainly not the panacea for increased organ donation. Obviously the
Act is helpful in reflecting the wishes of the potential donor, but
the key to transforming a potential donor to an actual donor occurs
within the hospital setting. Therefore, we are not certain that the
Uniform Anatomical Gift Act should be the subject of any great degree
It is the [IUd s
increase their efforts toward this goal. The MOB, for instance, is
particularly pleased with its own system for harvesting organs in
the Missouri and Kansas regions as results will indicate Per^P»
reviewing successful retrieval efforts within various OPAs would be
the best beginning in determining or suggesting an overall program.
814
Additionally, it has long been the position of the MOB that
there are many areas of the country which are extremely under-
developed in organ retrieval. It would seem logical that the first
step would be to recognize and designate those areas or states of
the country which are in need of an organ retrieval effort, and
then possibly assist established OPAs to enter these areas and set
up an organized system. However, successful OPAs have great diffi-
culty in going about this project without some type of seed money
or grant program, and where the current regulations simply do not
allow for such expansion. It is this first step in bringing in
the entire country within organized retrieval efforts which should
be analyzed and addressed.
The second area of inquiry concerning whether or not emergency
rooms should be required to document whether patients are potential
organ donors is one of great sensitivity and should be approached
very carefully. It is the MOB's position that utilizing statutes
or regulations to screen potential donors may be too intrusive, and
therefore should be approached cautiously and with input from all
groups associated with retrieval activity. Again, there are many
resources currently available which, if utilized by and coordinated
between hospitals and OPAs could easily provide a greater degree of
successful retrieval other than this proposition.
As to the third area of inquiry as to whether hospitals should
be required to have on-site transplant coordinators, it is our
position that again there are systems being utilized which could
probably be more successful than that which may be mandated by
statute or regulation. For instance, the MOB utilizes retrieval
teams within a great number of hospitals within its region from
which kidneys are procured. Each of these retrieval teams consist
of volunteers including an ICU nurse, an emergency room nurse, a
neurosurgeon, and a representative of pastoral care. The MOB
has worked with these various hospitals over the past years in
establishing these retrieval teams. This has allowed a tremendous
amount of coordination between the MOB and the retrieval hospital
in providing all aspects of donor activity from treatment to donor
family ministry. The key elements of this effort are the volunteers
which make up these retrieval teams. It is our opinion that this
system has worked quite successfully and is the greatest substitution
for any type of federal regulatory system that might be imposed.
The fourth area of inquiry concerning the utilization of tax
incentives for cadaveric organ donation is of such great sensitivity
that, again, it should be approached with great caution with input
from all groups associated with organ retrieval efforts. The MOB
does not take an official position on this issue but warns the Sub-
committee that even a public forum on this issue could sensitize
-3-
815
some individuals against organ donation. It must be remembered
that organ retrieval is still somewhat in its infancy, and the
evolution of social attitudes toward organ donation require a
high degree of sensitivity and emotion. Thus, creating monetary
incentives for organ donation may or may not be an appropriate
vehicle to that end.
Regarding the fifth area of inquiry as to whether or not
more regional networks should be established for the exchange,
collection, and distribution of organs, the MOB would agree in
general to such a proposition. The only caveat in establishing
a framework for multi-regional efforts would be the role of the
federal government in this area. The MOB does not feel that it
would be the role of the government to take an active part in
creating and managing regional sharing networks. It is the MOB's
position that organ retrieval can be best managed in the private
sector. However, and reflecting on our comments concerning the
first area of inquiry above, federal grant projects or seed money
concepts allowing established OPAs to more fully regionalize into
under-developed areas of the country may be an effective role for
the government. Additionally, because of its resources, the
government could coordinate an exchange of ideas from the various
OPAs, and thereby assisting the private sector in establishing
effective regional networks for the purposes outlined in the
proposition.
Finally, as to the sixth area of inquiry as to whether there
should be more effective national registries of patients awaiting
transplantation, the MOB fully supports this proposition, and in
the same vein as its recommendations pertaining to the establish-
ment of more regional networks. Furthermore, the current regulations
stifle the opportunity of established OPAs to retrieve organs other
than kidneys. Allowing organ retrieval to extend into extra-organ
retrieval, and utilizing the current kidney registries now utilized,
would do much to further advance activity in all phases of transplant
therapy.
We hope that these comments will be of some value to your Sub-
committee in its review of the total organ procurement program. If
we can assist you further by answering any questions or providing
further information, please do not hesitate to contact me, or the
Midwest Organ Bank through its Executive Director, Mr. Larry Kist,
4006 Central, Kansas City, Missouri 64111. Thank you in advance
816
for your attention to this information and we look forward to the
findings of the Sub-committee in its efforts.
I am,
REA/jmp
Enclosures
cc : Mr. Larry Kist
Respectfully yours,
[CHARD E. ARMITAGE
Attorney at Law
817
MEMORANDUM
TO: Congress DATE: August, 1980
FROM: Midwest Organ Bank, Inc.
RE: Public Law 95-292
The purpose of this memorandum is to provide a general over-
view of the concerns on behalf of independent organ procurement
agencies and histocompatibility laboratories with Public Law 95-292
and the supporting regulations. Public Law 95-292, signed into law
on June 13th, 1978, amends the End-Stage Renal Disease coverage
under the Medicare program. The portion of that legislation attrib-
utable to this discussion is attached to the memorandum. A more de-
tailed discussion of the issues is located in the Position Paper pre-
pared by the Midwest Organ Bank and presented to the Subcommittee on
Health of the House Ways and Means Committee.
I. LEGISLATION
Public Law 95-292 essentially provides for reimbursement of
costs through transplant centers to organ procurement agencies and
histocompatibility laboratories. Following passage of this amend-
ment, the Health Care Financing Administration promulgated certain
regulations substantially placing organ procurement agencies and
histocompatibility laboratories within the existing provider regu-
latory scheme. Prior to passage of the amendment, reimbursement was
based on a negotiation of budgets between the local intermediary and
the O.P.A. and laboratory within its region. Following passage of
the amendment, the regulations provided for the appointment of a
national intermediary with cost reimbursement to be based on cost-
reports and audits conducted by that intermediary.
II. ISSUES
The specific concern of the Midwest Organ Bank with the pro-
posed cost reimbursement policy is that it may reduce the potential
for increased kidney transplants performed. The chief concerns of
the Midwest Organ Bank lie in the fact that the proposed cost reim-
818
bursement policy,
1. would appear to limit the agencies' ability to fund
or make capital equipment expenditures;
2. may severely hamper efforts to educate the general
public in organ donation by decreasing or disallowing
funds available for this effort;
3. limit the ability of the effected agencies to carry
out professional educational programs in organ re-
trieval by decreasing or disallowing funding for
these efforts;
4. may limit the agencies' ability to expand operations
as needed;
5. may severely restrict research activities and reduce
the chances for technological improvement;
6. may restrict the amount of reimbursement or disallow
reimbursement for special methods of transporting
kidneys ;
7. severely limit the ability of the effected agencies
to acquire funding from other sources ;
8. would interfere with non-renal business activities of
the agencies and laboratories ;
9. would generally dictate allowable costs and the extent
of the allowance of those costs.
In addition to the concern that the cost reimbursement policy may ad-
versely effect the number of kidney transplants, there is an additional
concern. This concern is related to the fact that the regulations for
reimbursement of O.P.A.'s and laboratories were issued on December 14,
1978, and to date no one seems to know exactly how the reimbursement
mechanism will be formulated or implemented. Included in this is the
possibility that when policies are finally developed, such regulations
may be retroactive. This could prove financially devastating to many
of the O.P.A.'s and laboratories. It is the feeling of the Midwest
Organ Bank that these concerns illustrate the disincentives to the
O.P.A.'s and laboratories to either stay in business or expand their
existing programs. Ultimately, such disincentives will result in
fewer available kidneys for transplantation.
819
The Midwest Organ Bank provides its services in a two-state
area of Kansas and Western Missouri. Its function is to provide
cadaveric transplants and tissue typing for patients throughout this
area It is important to point out the positive effect that such
agencies as the Midwest Organ Bank has to the transplant program
Sonant as well as to the nation on a whole. In 1979 the Midwest
Sr^an Bank supplied the equivalent of 120 kidneys with its organ re-
trieval efforts. The agency supplied the equivalent of A of the
kidneys used for cadaveric transplants in the United States. This
figure is significant in light of the fact that the region contains
only 3% of the Medicare population. Furthermore, it should be noted
that the independent agencies as a whole retrieve approximately 45 „
of all cadaveric kidneys used in transplantation.
III. POSITION
The position of the Midwest Organ Bank is primarily based upon
the relationship between the federal government and the independent
0 P.I 's and laboratories. What the Midwest Organ Bank proposes to
seek on behalf of all independent agencies and laboratories is an
emohasis on the "independent status" of such organizations Instead
of the use of a massive regulatory scheme incompatible with such or-
ganizations the return to a contractual relationship would appear
more viable' Similar to the reimbursement mechanism utilized prior
to the passage of Public Law 95-292, the Midwest Organ Bank contends
that cost containment can be realized through an annual prospective
budget negotiation process. It should be noted that Congress was
not necessarily dissatisfied with the previous program, but only with
the rising costs associated with transplantation.
The real issue then is whether Congress comprehended the type
of reimbursement mechanism and regulations installed in assoc t ion
with this legislation. If so, the inten to increase the number of
transplants for dialyzed patients will either stagnate or decrease.
The Midwest Organ Bank supports and encourages cost effectiveness
within its ownSoperat ion and recognizes that this is a chief concern
of Congress. However, other alternatives in the implementation of
the legislation should be explored.
820
PUBLIC LAW 95-292— JUNE 13, 1978
92 STAT. 309
42 L'SC 1395x.
42 USC 1395/.
Regulations.
ity), transplantation services, self-care home dialysis support services
which are furnished by the provider or facility, and routine profes-
sional services performed by a physician during a maintenance dialysis
episode if payments for his other professional services furnished to an
individual who has end-stage renal disease are made on the basis spec-
ified in paragraph (3) (A) of this subsection, and (H) payments to
or on behalf of such individuals for home dialysis supplies and equip-
ment. The requirements prescribed by the Secretary under subpara-
graph (A) shall include requirements for a minimum utilization rate
for covered procedures and for self-dialysis training programs.
"(2) (A) With respect to payments for dialysis services furnished
by providers of services and renal dialysis facilities to individuals
determined to have end-staj;e. renal disease for which payments may
be made under part B of this title, such payments (unless otherwise 42 USC 1395j.
provided in this section) shall be. equal to 80 percent of the amounts
determined in accordance, with subparagraph (B); and with respect
to payments for services for which payments may be made under part
A of this title, the amounts of such payments /which amounts shall 42 USC 1395.
not exceed in resnect to costs in nrocnrini* or.n.ns nttrihntnhle tn nnV-
inents made, to an or/r;tn_{)nx-nrcment agency or histocompatibility
lanoraTory. the costs incurred by that aLwyor laboratory ) shall be
determined in accordance with section 1801 (v). Payments shall be
made to a renal dialysis facility only if it agrees to accept such pay-
ments as payment in full for covered services, except for payment by
the individual of 20 percent of the estimated amounts for such services
calculated on the basis established by the Secretary under subpara-
graph (B) and the deductible amount imposed by section 1833(b).
"(B) The Secretary shall prescribe in regulations any methods and
procedures to (i ) determine the costs incurred by providers of services
and renal dialysis facilities in furnishing covered services to indi-
viduals determined to have end-stage renal disease, and (ii) deter-
mine, on a cost-related basis or other economical and equitable basis
(including any basis authorized under section IRtil(v)), the amounts
of payments to be made for part R services furnished by such providers
and facilities to such individuals. Such regulations shall provide for
the implementation of appropriate incentives for encouraging more
efficient and effective delivery of services (consistent with quality
care), and shall include, to the extent determined feasible by the Sec-
retary, a system for classifying comparable providers and facilities,
and prospectively set rates or target rates with arrangements for
sharing such reductions in costs as may be attributable to more efficient
and effective delivery of services.
"(C) Such regulations, in the case of services furnished by pro-
prietary providers and facilities may include, if the Secretary finds it
feasible and appropriate, provision for recognition of a reasonable
rate of return on equity capital, providing such rate of return does not
exceed the rate of return stipulated in section lSf»l(v) (1) (B).
"(D) For purposes of section 1878, a renal dialysis facility shall he 42 USC 1395oo
treated as a provider of services.
"(3) With respect to payments for physicians' services furnished to
individuals determined to have end-stage, renal disease, the Secretary
shall pay 80 i>ereent of the amounts calculated for such services —
"(A) on a reasonable charge basis (but may, in such case, make
payment on the basis of the prevailing charges of other physicians
for comparable services) except that payment may not. be made
under this subparagraph for routine services furnished during a
maintenance dialysis episode, or
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